Advanced Solid Tumors
Conditions
Keywords
Colorectal, colon, CRC, solid tumors, check point inhibitors, immunotherapy, metastatic
Brief summary
This is a multicenter, open-label, dose-escalation, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, pharmacokinetic (PK), pharmacodynamics, and immunogenicity of durvalumab (MEDI4736) in combination with monalizumab (IPH2201) in adult participants with selected advanced solid tumors and the combination of durvalumab and monalizumab (IPH2201) standard of care systemic therapy with or without biological agent and monalizumab (IPH2201) with biological agent administered to participants with recurrent or metastatic colorectal cancer (CRC).
Detailed description
The study consists of 3 parts: dose escalation (Part 1), dose expansion (Part 2), and dose exploration (Part 3). Part 1 will evaluate dose escalation of durvalumab in combination with monalizumab in adult participants with select advanced solid tumor malignancies. Part 2 will evaluate further the identified dose of durvalumab in combination with monalizumab from Part 1 in adult participants with select advanced solid tumor malignancies. Part 3 will evaluate dose exploration of durvalumab in combination with monalizumab and standard of care systemic therapy with or without biological agent, and monalizumab in combination with biological agent in adult participants with CRC.
Interventions
DRUGMonalizumab
Participants will receive IV infusion of monalizumab as stated in arm description.
DRUGDurvalumab
Participants will receive IV infusion of durvalumab as stated in arm description.
DRUGCetuximab
Participants will receive IV infusion of cetuximab as stated in arm description.
DRUGmFOLFOX6
Participants will receive IV infusion of mFOLFOX as stated in arm description.
DRUGBevacizumab
Participants will receive IV infusion of bevacizumab as stated in arm description.
Sponsors
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Participants must have histologic documentation of advanced recurrent or metastatic cancer. 2. Participants must be at the recurrent/metastatic setting, with selected advanced solid tumors. 3. Participants must have at least one lesion that is measurable by RECIST v1.1 4. Part 3, Dose exploration, CRC participants can be treatment naïve but should not have received more than two line of systemic therapy in the recurrent/metastatic setting.
Exclusion criteria
1. Prior treatment with immunotherapy agents. Prior treatment with antitumor vaccines may be permitted upon discussion with the medical monitor. 2. Prior participation in clinical studies that include durvalumab alone or in combination, where the study has registrational intent and the analyses for the primary endpoint have not yet been completed 3. Receipt of any conventional or investigational anticancer therapy within 4 weeks prior to the first dose of study treatment 4. Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions is acceptable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Day 1 through 246.9 weeks (maximum observed duration) | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. Any TEAEs data is inclusive of both serious and other adverse events (non-serious). |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1 (baseline) through 246.9 weeks (maximum observed duration) | Change from baseline in SBP and DBP (minimum post baseline change \[PBC\] and maximum PBC) are reported. |
| Change From Baseline in Respiratory Rate (RR) | Day 1 (baseline) through 246.9 weeks (maximum observed duration) | Change from baseline in RR (minimum PBC and maximum PBC) are reported. |
| Change From Baseline in Pulse Rate (PR) | Day 1 (baseline) through 246.9 weeks (maximum observed duration) | Change from baseline in PR (minimum PBC and maximum PBC) are reported. |
| Change From Baseline in Body Temperature (BT) | Day 1 (baseline) through 246.9 weeks (maximum observed duration) | Change from baseline in BT (minimum PBC and maximum PBC) are reported. |
| Change From Baseline in Oxygen Saturation (OS) | Day 1 (baseline) through 246.9 weeks (maximum observed duration) | Change from baseline in OS (minimum PBC and maximum PBC) are reported. |
| Number of Participants With Notable Change in QTcF and QTcB From Baseline | Day 1 (baseline) through 246.9 weeks (maximum observed duration) | Participants who had notable QTcF and QTcB interval change from baseline are reported. |
| Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Day 1 (baseline) through 246.9 weeks (maximum observed duration) | Number of participants with at least 2-Grade shift from baseline in laboratory parameters are reported. |
| Number of Participants With Dose Limiting Toxicities (DLTs) | From Day 1 to 28 days after the first dose of study drugs | DLT: Any study drug related Grade (G) 3 or higher toxicity that occurred during DLT evaluation period including: any G\>=3 noninfectious colitis/pneumonitis, liver transaminase elevation (TE) \>=5 but =\<8 upper limit of normal (ULN), any G4 immune-mediated AE (imAE)/immune-related AE (irAE), any G\>=3 clinically significant non-hematologic toxicity, TE \>8 ULN or total bilirubin (TBL) \>5 ULN, increase in AST or ALT \>=3 ULN along with TBL \>=2 ULN, thrombocytopenia (G3/4 associated with G3/higher hemorrhage, G3 that did not improve by at least 1 grade within 7 days, and G4), G4 febrile neutropenia (FN), G3 FN of \>=5 days and G3 FN regardless of duration, G4 neutropenia of \>7 days, G3/4 neutropenia not associated with fever/systemic infection, and anemia (G3 and G4). |
| Percentage of Participants With Objective Response (OR) in Exploration Cohorts C1A and C1B | Baseline (Days -28 to -1) through 54.8 months (maximum observed duration) | The OR is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST V 1.1) guidelines. The CR is defined as disappearance of all target and non-target lesions and normalization of tumor marker level lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in between. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With OR | Baseline (Days -28 to -1) through 54.8 months (maximum observed duration) | The OR is defined as best overall response of CR or confirmed PR according to RECIST V 1.1 guidelines. The CR is defined as disappearance of all target and non-target lesions and normalization of tumor marker level lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in between. |
| Percentage of Participants With OR in Exploration Cohorts C2A and C2B | Baseline (-28 to -1 day) through 54.8 months (maximum observed duration) | The OR is defined as best overall response of confirmed CR or confirmed PR according to RECIST V 1.1 guidelines. The CR is defined as disappearance of all target and non-target lesions and normalization of tumor marker level lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in between. |
| Percentage of Participants With Disease Control (DC) | Baseline (-28 to -1 day) through 54.8 months (maximum observed duration) | The DC is defined as best overall response of confirmed CR, confirmed PR, or stable disease (SD) based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and normalization of tumor marker level lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in between. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. Participants with SD were included in the DC if they maintained SD for \>= 8 weeks from start of treatment. The DCR16 and DCR24 are reported (participants with SD \>= 16 weeks and \>=24 weeks). |
| Percentage of Participants With DC in Exploration Cohorts (C1A, C1B, C2A, and C2B) | Baseline (-28 to -1 day) through 54.8 months (maximum observed duration) | The DC is defined as best overall response of confirmed CR, confirmed PR, or SD based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and normalization of tumor marker level lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in between. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. Participants with SD were included in the DC if they maintained SD for \>= 8 weeks from start of treatment. The DCR16 and DCR24 are reported (participants with SD \>= 16 weeks and \>=24 weeks). |
| Duration of Response (DoR) | Baseline (-28 to -1 day) through 54.8 months (maximum observed duration) | The DoR is defined as the duration from the first documentation of OR (confirmed CR or confirmed PR) to the first documented disease progression (PD) based on RECIST v1.1 or death due to any cause, whichever occurred first. The CR is defined as disappearance of all target and non-target lesions and normalization of tumor marker level lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in between. The PD is defined as at least a 20% increase in the sum of diameters of target lesions or unequivocal progression of existing non-target lesions, taking as reference the smallest sum on study and appearance of one or more new lesions. The DoR was evaluated using Kaplan-Meier method. |
| DoR in Exploration Cohorts (C1A, C1B, C2A, and C2B) | Baseline (-28 to -1 day) through 54.8 months (maximum observed duration) | The DoR is defined as the duration from the first documentation of OR (confirmed CR or confirmed PR) to the first documented PD based on RECIST v1.1 or death due to any cause, whichever occurred first. The CR is defined as disappearance of all target and non-target lesions and normalization of tumor marker level lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in between. The PD is defined as at least a 20% increase in the sum of diameters of target lesions or unequivocal progression of existing non-target lesions, taking as reference the smallest sum on study and appearance of one or more new lesions. The DoR was evaluated using Kaplan-Meier method. |
| Progression-Free Survival (PFS) | Baseline (-28 to -1 day) through 54.8 months (maximum observed duration) | The PFS is defined as the time from the start of study treatment until the first documentation of PD based on RECIST v1.1 or death due to any cause, whichever occurred first. The PD is defined as at least a 20% increase in the sum of diameters of target lesions or unequivocal progression of existing non-target lesions, taking as reference the smallest sum on study and appearance of one or more new lesions. The PFS was estimated using Kaplan-Meier method. |
| Progression-Free Survival (PFS) in Exploration Cohorts (C1A, C1B, C2A, and C2B) | Baseline (-28 to -1 day) through 54.8 months (maximum observed duration) | The PFS is defined as the time from the start of study treatment until the first documentation of PD based on RECIST v1.1 or death due to any cause, whichever occurred first. The PD is defined as at least a 20% increase in the sum of diameters of target lesions or unequivocal progression of existing non-target lesions, taking as reference the smallest sum on study and appearance of one or more new lesions. The PFS was estimated using Kaplan-Meier method. |
| Overall Survival | Baseline (-28 to -1 day) through 54.8 months (maximum observed duration) | The overall survival is defined as the time from the start of study treatment until death due to any cause. The overall survival was estimated using Kaplan-Meier method. |
| Overall Survival in Exploration Cohorts (C1A, C1B, C2A, and C2B) | Baseline (-28 to -1 day) through 54.8 weeks (maximum observed duration) | The overall survival is defined as the time from the start of study treatment until death due to any cause. The overall survival was estimated using Kaplan-Meier method. |
| Maximum Observed Serum Concentration (Cmax) of Monalizumab | Day 85: Pre-dose and end of infusion (within 10 minutes) after cohort specific infusions | Serum Cmax of monalizumab at pre-dose and end of infusion are reported. |
| Minimum Observed Serum Concentration (Cmin) of Monalizumab | Day 85: Pre-dose and end of infusion (within 10 minutes) after cohort specific infusions | Serum Cmin of monalizumab at pre-dose and end of infusion are reported. |
| Serum Concentration of Durvalumab | Pre-dose (PRE) on Day 1 of Weeks 1, 5, 9, 13, and 25 and post-dose (POST) on Day 1 of Weeks 1 and 13 | Serum concentration of durvalumab is reported. |
| Serum Concentration of Cetuximab | Pre-dose (PRE) on Day 1 of Weeks 1, 5, 9, and 13 and post-dose (POST) on Day 1 of Weeks 1, 5, and 13 | Serum concentration of cetuximab is reported. |
| Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Day 1 through 54.8 months (Day 1 of Weeks 1, 5, 13, and 25, and 90 days after the last dose of monalizumab) | Number of participants with positive ADA to monalizumab are reported. Persistent positive is defined as positive at \>= 2 post-baseline assessments (with \>=16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at \>= 2 post-baseline assessments (with \<16 weeks between first and last positive). Treatment-boosted ADA is defined as baseline ADA titer that was boosted to a 4-fold or higher level following drug administration. Treatment-emergent ADA is defined as the sum of treatment-induced ADA (post-baseline positive only) and treatment-boosted ADA. |
| Number of Participants With Positive ADA to Durvalumab | Day 1 through 54.8 months (Day 1 of Weeks 1, 5, 13, and 25, and 90 days after the last dose of monalizumab) | Number of participants with positive ADA to monalizumab are reported. Persistent positive is defined as positive at \>= 2 post-baseline assessments (with \>= 16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at \>= 2 post-baseline assessments (with \<16 weeks between first and last positive). Treatment-boosted ADA is defined as baseline ADA titer that was boosted to a 4-fold or higher level following drug administration. Treatment-emergent ADA is defined as the sum of treatment-induced ADA (post-baseline positive only) and treatment-boosted ADA. |
| Number of Participants With Positive ADA to Cetuximab | Day 1 through 54.8 months (Day 1 of Weeks 1, 5, 9 [if EOT occurred], and 13, and 30 days after the last dose of monalizumab) | Number of participants with positive ADA to cetuximab are reported. Persistent positive is defined as positive at \>= 2 post-baseline assessments (with \>=16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at \>= 2 post-baseline assessments (with \<16 weeks between first and last positive). Treatment-boosted ADA is defined as baseline ADA titer that was boosted to a 4-fold or higher level following drug administration. Treatment-emergent ADA is defined as the sum of treatment-induced ADA (post-baseline positive only) and treatment-boosted ADA. |
| Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | Screening (Days -28 to -1) | Number of participants with PD-L1 expression in pre-treatment tumor biopsies is reported. The participants were stratified into four categories: tumor cells (TC) \>= 25%, TC\<25%, TC\>=1%, and TC\<1%, based on the historical use of PD-L1 cutoffs. |
| Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | Screening (Days -28 to -1) | The HLA-E expression in pre-treatment tumor biopsies is reported. |
Countries
Australia, Belgium, Canada, France, Hungary, Italy, New Zealand, South Korea, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W Participants received intravenous (IV) infusions of durvalumab 1500 mg every 4 weeks (Q4W) in combination with monalizumab 22.5 mg every 2 weeks (Q2W) up to 3 years until unacceptable toxicity, documentation of confirmed disease progression (PD), or documentation of subject withdrawal for another reason. | 3 |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W Participants received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 75 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. | 3 |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W Participants received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 225 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. | 3 |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W Participants received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. | 18 |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W Participants received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q4W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. | 18 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) Participants with microsatellite-stable colorectal cancer (MSS-CRC) received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. | 40 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) Participants with ovarian cancer received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. | 40 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) Participants with endometrial MSS received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. | 40 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) Participants with non-small cell lung cancer (NSCLC) received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. | 20 |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W Participants with first-line (1L) MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W plus mFOLFOX (oxaliplatin 85 mg/m\^2 IV infusion, folinic acid 400 mg/m\^2 infusion, fluorouracil 400 mg/m\^2 IV bolus, followed by 2400 mg/m\^2 continuous IV infusion over 46 to 48 hours on Day 1) Q2W plus IV infusion of bevacizumab 5 mg/kg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. | 18 |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W Participants with 1L MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W, plus mFOLFOX6 (oxaliplatin 85 mg/m\^2, folinic acid 400 mg/m\^2, fluorouracil 400 mg/m\^2 IV bolus, followed by 2400 mg/m\^2 continuous IV infusion over 46 to 48 hours on Day 1) Q2W plus IV infusion of cetuximab (loading dose of 400 mg/m\^2 on Day 1, followed by maintenance dose of 250 mg/m\^2 IV infusion every week starting on Day 8, then changed to 500 mg/m\^2 IV infusion Q2W) up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. | 18 |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W Participants with recurrent or metastatic third-line (3L) RAS mutant MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m\^2 on Day 1 then 500 mg/m\^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. | 40 |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W Participants with recurrent or metastatic 3L RAS mutant MSS-CRC received IV infusion of monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m\^2 on Day 1 then 500 mg/m\^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. | 41 |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W Participants with recurrent or metastatic 3L RAS/BRAF wild type MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m\^2 on Day 1 then 500 mg/m\^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. | 44 |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W Participants with recurrent or metastatic 3L RAS/BRAF wild type MSS-CRC received IV infusion of monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m\^2 on Day 1 then 500 mg/m\^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. | 37 |
| Total | 383 |
Baseline characteristics
| Characteristic | Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 58 Years STANDARD_DEVIATION 21.7 | 55.7 Years STANDARD_DEVIATION 18 | 59 Years STANDARD_DEVIATION 15.1 | 56.4 Years STANDARD_DEVIATION 13.5 | 60 Years STANDARD_DEVIATION 13.5 | 53.6 Years STANDARD_DEVIATION 12.9 | 61.5 Years STANDARD_DEVIATION 9.1 | 63.7 Years STANDARD_DEVIATION 8.5 | 63.2 Years STANDARD_DEVIATION 7.9 | 60.8 Years STANDARD_DEVIATION 9.9 | 55.4 Years STANDARD_DEVIATION 9.4 | 55.8 Years STANDARD_DEVIATION 10.7 | 52.3 Years STANDARD_DEVIATION 10.6 | 55.9 Years STANDARD_DEVIATION 11.3 | 58.8 Years STANDARD_DEVIATION 9.6 | 57.8 Years STANDARD_DEVIATION 11.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants | 3 Participants | 0 Participants | 6 Participants | 5 Participants | 3 Participants | 2 Participants | 1 Participants | 1 Participants | 3 Participants | 6 Participants | 4 Participants | 0 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 2 Participants | 3 Participants | 15 Participants | 17 Participants | 34 Participants | 35 Participants | 37 Participants | 16 Participants | 17 Participants | 17 Participants | 37 Participants | 35 Participants | 40 Participants | 37 Participants | 344 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 3 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 4 Participants | 9 Participants | 8 Participants | 14 Participants | 13 Participants | 58 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants | 4 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 2 Participants | 2 Participants | 1 Participants | 15 Participants |
| Race (NIH/OMB) White | 3 Participants | 3 Participants | 3 Participants | 15 Participants | 15 Participants | 36 Participants | 35 Participants | 30 Participants | 16 Participants | 13 Participants | 13 Participants | 29 Participants | 30 Participants | 25 Participants | 22 Participants | 288 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 2 Participants | 17 Participants | 6 Participants | 15 Participants | 40 Participants | 40 Participants | 6 Participants | 8 Participants | 8 Participants | 17 Participants | 16 Participants | 17 Participants | 18 Participants | 216 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 12 Participants | 25 Participants | 0 Participants | 0 Participants | 14 Participants | 10 Participants | 10 Participants | 23 Participants | 25 Participants | 27 Participants | 19 Participants | 167 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 3 | 3 / 3 | 0 / 3 | 16 / 18 | 14 / 18 | 29 / 40 | 34 / 40 | 28 / 40 | 19 / 20 | 10 / 18 | 8 / 18 | 29 / 40 | 29 / 41 | 29 / 44 | 27 / 37 |
| other Total, other adverse events | 3 / 3 | 3 / 3 | 3 / 3 | 18 / 18 | 16 / 18 | 39 / 40 | 40 / 40 | 39 / 40 | 20 / 20 | 18 / 18 | 18 / 18 | 39 / 39 | 41 / 41 | 44 / 44 | 36 / 37 |
| serious Total, serious adverse events | 1 / 3 | 0 / 3 | 1 / 3 | 8 / 18 | 4 / 18 | 11 / 40 | 16 / 40 | 17 / 40 | 7 / 20 | 10 / 18 | 11 / 18 | 10 / 39 | 5 / 41 | 9 / 44 | 11 / 37 |
Outcome results
Primary
Change From Baseline in Body Temperature (BT)
Change from baseline in BT (minimum PBC and maximum PBC) are reported.
Time frame: Day 1 (baseline) through 246.9 weeks (maximum observed duration)
Population: As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Body Temperature (BT) | BT min PBC | -0.30 degree Celsius | Standard Deviation 0.3 |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Body Temperature (BT) | BT max PBC | 0.63 degree Celsius | Standard Deviation 0.32 |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Body Temperature (BT) | BT min PBC | -0.37 degree Celsius | Standard Deviation 0.38 |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Body Temperature (BT) | BT max PBC | 0.93 degree Celsius | Standard Deviation 0.92 |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Body Temperature (BT) | BT min PBC | -0.67 degree Celsius | Standard Deviation 0.55 |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Body Temperature (BT) | BT max PBC | 0.50 degree Celsius | Standard Deviation 0.26 |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Body Temperature (BT) | BT min PBC | -0.66 degree Celsius | Standard Deviation 0.56 |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Body Temperature (BT) | BT max PBC | 0.78 degree Celsius | Standard Deviation 0.72 |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Change From Baseline in Body Temperature (BT) | BT max PBC | 0.60 degree Celsius | Standard Deviation 0.73 |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Change From Baseline in Body Temperature (BT) | BT min PBC | -0.48 degree Celsius | Standard Deviation 0.28 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Change From Baseline in Body Temperature (BT) | BT max PBC | 0.65 degree Celsius | Standard Deviation 0.43 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Change From Baseline in Body Temperature (BT) | BT min PBC | -0.62 degree Celsius | Standard Deviation 0.39 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Change From Baseline in Body Temperature (BT) | BT min PBC | -0.63 degree Celsius | Standard Deviation 0.42 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Change From Baseline in Body Temperature (BT) | BT max PBC | 0.64 degree Celsius | Standard Deviation 0.46 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Change From Baseline in Body Temperature (BT) | BT min PBC | -0.47 degree Celsius | Standard Deviation 0.32 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Change From Baseline in Body Temperature (BT) | BT max PBC | 0.77 degree Celsius | Standard Deviation 0.47 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Change From Baseline in Body Temperature (BT) | BT min PBC | -0.51 degree Celsius | Standard Deviation 0.26 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Change From Baseline in Body Temperature (BT) | BT max PBC | 0.72 degree Celsius | Standard Deviation 0.46 |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Change From Baseline in Body Temperature (BT) | BT max PBC | 0.89 degree Celsius | Standard Deviation 0.51 |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Change From Baseline in Body Temperature (BT) | BT min PBC | -0.84 degree Celsius | Standard Deviation 0.46 |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Change From Baseline in Body Temperature (BT) | BT min PBC | -0.79 degree Celsius | Standard Deviation 0.48 |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Change From Baseline in Body Temperature (BT) | BT max PBC | 0.56 degree Celsius | Standard Deviation 0.43 |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Change From Baseline in Body Temperature (BT) | BT max PBC | 0.75 degree Celsius | Standard Deviation 0.57 |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Change From Baseline in Body Temperature (BT) | BT min PBC | -0.51 degree Celsius | Standard Deviation 0.39 |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Change From Baseline in Body Temperature (BT) | BT max PBC | 0.70 degree Celsius | Standard Deviation 0.53 |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Change From Baseline in Body Temperature (BT) | BT min PBC | -0.52 degree Celsius | Standard Deviation 0.33 |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Change From Baseline in Body Temperature (BT) | BT min PBC | -0.65 degree Celsius | Standard Deviation 0.45 |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Change From Baseline in Body Temperature (BT) | BT max PBC | 0.91 degree Celsius | Standard Deviation 0.64 |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Change From Baseline in Body Temperature (BT) | BT max PBC | 0.81 degree Celsius | Standard Deviation 0.66 |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Change From Baseline in Body Temperature (BT) | BT min PBC | -0.66 degree Celsius | Standard Deviation 0.58 |
Primary
Change From Baseline in Oxygen Saturation (OS)
Change from baseline in OS (minimum PBC and maximum PBC) are reported.
Time frame: Day 1 (baseline) through 246.9 weeks (maximum observed duration)
Population: As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who were evaluable for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Oxygen Saturation (OS) | OS min PBC | -1.00 Percentage of oxygen saturation | — |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Oxygen Saturation (OS) | OS max PBC | -1.00 Percentage of oxygen saturation | — |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Oxygen Saturation (OS) | OS max PBC | -3.00 Percentage of oxygen saturation | — |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Oxygen Saturation (OS) | OS min PBC | -3.00 Percentage of oxygen saturation | — |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Change From Baseline in Oxygen Saturation (OS) | OS max PBC | -3.00 Percentage of oxygen saturation | — |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Change From Baseline in Oxygen Saturation (OS) | OS min PBC | -3.00 Percentage of oxygen saturation | — |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Change From Baseline in Oxygen Saturation (OS) | OS min PBC | -0.67 Percentage of oxygen saturation | Standard Deviation 1.53 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Change From Baseline in Oxygen Saturation (OS) | OS max PBC | -0.67 Percentage of oxygen saturation | Standard Deviation 1.53 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Change From Baseline in Oxygen Saturation (OS) | OS max PBC | -21.00 Percentage of oxygen saturation | — |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Change From Baseline in Oxygen Saturation (OS) | OS min PBC | -21.00 Percentage of oxygen saturation | — |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Change From Baseline in Oxygen Saturation (OS) | OS min PBC | 0 Percentage of oxygen saturation | — |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Change From Baseline in Oxygen Saturation (OS) | OS max PBC | 0 Percentage of oxygen saturation | — |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Change From Baseline in Oxygen Saturation (OS) | OS max PBC | 0.50 Percentage of oxygen saturation | Standard Deviation 2.12 |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Change From Baseline in Oxygen Saturation (OS) | OS min PBC | 0.50 Percentage of oxygen saturation | Standard Deviation 2.12 |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Change From Baseline in Oxygen Saturation (OS) | OS max PBC | -4.00 Percentage of oxygen saturation | — |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Change From Baseline in Oxygen Saturation (OS) | OS min PBC | -4.00 Percentage of oxygen saturation | — |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Change From Baseline in Oxygen Saturation (OS) | OS max PBC | 0.50 Percentage of oxygen saturation | Standard Deviation 0.71 |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Change From Baseline in Oxygen Saturation (OS) | OS min PBC | 0.50 Percentage of oxygen saturation | Standard Deviation 0.71 |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Change From Baseline in Oxygen Saturation (OS) | OS min PBC | -1.00 Percentage of oxygen saturation | — |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Change From Baseline in Oxygen Saturation (OS) | OS max PBC | -1.00 Percentage of oxygen saturation | — |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Change From Baseline in Oxygen Saturation (OS) | OS min PBC | -0.33 Percentage of oxygen saturation | Standard Deviation 2.8 |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Change From Baseline in Oxygen Saturation (OS) | OS max PBC | -0.33 Percentage of oxygen saturation | Standard Deviation 2.8 |
Primary
Change From Baseline in Pulse Rate (PR)
Change from baseline in PR (minimum PBC and maximum PBC) are reported.
Time frame: Day 1 (baseline) through 246.9 weeks (maximum observed duration)
Population: As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who were evaluable for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Pulse Rate (PR) | PR min PBC | -5.33 beats/min | Standard Deviation 2.52 |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Pulse Rate (PR) | PR max PBC | 38.33 beats/min | Standard Deviation 10.02 |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Pulse Rate (PR) | PR max PBC | 16.67 beats/min | Standard Deviation 6.11 |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Pulse Rate (PR) | PR min PBC | -14.33 beats/min | Standard Deviation 6.51 |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Pulse Rate (PR) | PR min PBC | -7.00 beats/min | Standard Deviation 1.73 |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Pulse Rate (PR) | PR max PBC | 21.67 beats/min | Standard Deviation 8.08 |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Pulse Rate (PR) | PR max PBC | 19.33 beats/min | Standard Deviation 15.05 |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Pulse Rate (PR) | PR min PBC | -15.67 beats/min | Standard Deviation 11.83 |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Change From Baseline in Pulse Rate (PR) | PR max PBC | 17.78 beats/min | Standard Deviation 11.12 |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Change From Baseline in Pulse Rate (PR) | PR min PBC | -15.39 beats/min | Standard Deviation 9.2 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Change From Baseline in Pulse Rate (PR) | PR min PBC | -14.70 beats/min | Standard Deviation 9.39 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Change From Baseline in Pulse Rate (PR) | PR max PBC | 20.28 beats/min | Standard Deviation 10.03 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Change From Baseline in Pulse Rate (PR) | PR max PBC | 20.68 beats/min | Standard Deviation 13.42 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Change From Baseline in Pulse Rate (PR) | PR min PBC | -12.24 beats/min | Standard Deviation 10.1 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Change From Baseline in Pulse Rate (PR) | PR min PBC | -11.38 beats/min | Standard Deviation 10.98 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Change From Baseline in Pulse Rate (PR) | PR max PBC | 22.60 beats/min | Standard Deviation 12.17 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Change From Baseline in Pulse Rate (PR) | PR max PBC | 25.80 beats/min | Standard Deviation 11.27 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Change From Baseline in Pulse Rate (PR) | PR min PBC | -13.95 beats/min | Standard Deviation 9.12 |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Change From Baseline in Pulse Rate (PR) | PR min PBC | -15.67 beats/min | Standard Deviation 8.84 |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Change From Baseline in Pulse Rate (PR) | PR max PBC | 21.28 beats/min | Standard Deviation 13.48 |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Change From Baseline in Pulse Rate (PR) | PR max PBC | 21.06 beats/min | Standard Deviation 12.24 |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Change From Baseline in Pulse Rate (PR) | PR min PBC | -18.11 beats/min | Standard Deviation 11.98 |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Change From Baseline in Pulse Rate (PR) | PR min PBC | -15.74 beats/min | Standard Deviation 11.2 |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Change From Baseline in Pulse Rate (PR) | PR max PBC | 23.54 beats/min | Standard Deviation 12.83 |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Change From Baseline in Pulse Rate (PR) | PR min PBC | -13.15 beats/min | Standard Deviation 11.89 |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Change From Baseline in Pulse Rate (PR) | PR max PBC | 23.88 beats/min | Standard Deviation 11.31 |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Change From Baseline in Pulse Rate (PR) | PR min PBC | -13.91 beats/min | Standard Deviation 7.04 |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Change From Baseline in Pulse Rate (PR) | PR max PBC | 25.18 beats/min | Standard Deviation 13.71 |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Change From Baseline in Pulse Rate (PR) | PR max PBC | 27.38 beats/min | Standard Deviation 13.92 |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Change From Baseline in Pulse Rate (PR) | PR min PBC | -11.68 beats/min | Standard Deviation 9.02 |
Primary
Change From Baseline in Respiratory Rate (RR)
Change from baseline in RR (minimum PBC and maximum PBC) are reported.
Time frame: Day 1 (baseline) through 246.9 weeks (maximum observed duration)
Population: As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Respiratory Rate (RR) | RR min PBC | -2.00 breaths/min | Standard Deviation 2 |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Respiratory Rate (RR) | RR max PBC | 2.00 breaths/min | Standard Deviation 3.46 |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Respiratory Rate (RR) | RR max PBC | 2.33 breaths/min | Standard Deviation 0.58 |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Respiratory Rate (RR) | RR min PBC | -3.00 breaths/min | Standard Deviation 1 |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Respiratory Rate (RR) | RR min PBC | -1.33 breaths/min | Standard Deviation 2.31 |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Respiratory Rate (RR) | RR max PBC | 2.67 breaths/min | Standard Deviation 1.15 |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Respiratory Rate (RR) | RR min PBC | -1.78 breaths/min | Standard Deviation 1.31 |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Respiratory Rate (RR) | RR max PBC | 1.72 breaths/min | Standard Deviation 1.49 |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Change From Baseline in Respiratory Rate (RR) | RR max PBC | 1.83 breaths/min | Standard Deviation 1.42 |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Change From Baseline in Respiratory Rate (RR) | RR min PBC | -1.50 breaths/min | Standard Deviation 1.86 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Change From Baseline in Respiratory Rate (RR) | RR min PBC | -1.93 breaths/min | Standard Deviation 1.86 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Change From Baseline in Respiratory Rate (RR) | RR max PBC | 2.40 breaths/min | Standard Deviation 2.37 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Change From Baseline in Respiratory Rate (RR) | RR min PBC | -1.53 breaths/min | Standard Deviation 1.52 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Change From Baseline in Respiratory Rate (RR) | RR max PBC | 2.53 breaths/min | Standard Deviation 2.24 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Change From Baseline in Respiratory Rate (RR) | RR max PBC | 2.40 breaths/min | Standard Deviation 2.62 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Change From Baseline in Respiratory Rate (RR) | RR min PBC | -1.83 breaths/min | Standard Deviation 1.62 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Change From Baseline in Respiratory Rate (RR) | RR min PBC | -1.55 breaths/min | Standard Deviation 3.12 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Change From Baseline in Respiratory Rate (RR) | RR max PBC | 4.05 breaths/min | Standard Deviation 3.09 |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Change From Baseline in Respiratory Rate (RR) | RR min PBC | -2.00 breaths/min | Standard Deviation 1.94 |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Change From Baseline in Respiratory Rate (RR) | RR max PBC | 2.50 breaths/min | Standard Deviation 2.09 |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Change From Baseline in Respiratory Rate (RR) | RR max PBC | 3.39 breaths/min | Standard Deviation 3.62 |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Change From Baseline in Respiratory Rate (RR) | RR min PBC | -1.67 breaths/min | Standard Deviation 1.78 |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Change From Baseline in Respiratory Rate (RR) | RR min PBC | -2.15 breaths/min | Standard Deviation 2.23 |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Change From Baseline in Respiratory Rate (RR) | RR max PBC | 1.85 breaths/min | Standard Deviation 1.73 |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Change From Baseline in Respiratory Rate (RR) | RR min PBC | -1.59 breaths/min | Standard Deviation 1.52 |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Change From Baseline in Respiratory Rate (RR) | RR max PBC | 2.00 breaths/min | Standard Deviation 1.55 |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Change From Baseline in Respiratory Rate (RR) | RR min PBC | -2.00 breaths/min | Standard Deviation 1.33 |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Change From Baseline in Respiratory Rate (RR) | RR max PBC | 2.59 breaths/min | Standard Deviation 1.83 |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Change From Baseline in Respiratory Rate (RR) | RR min PBC | -1.92 breaths/min | Standard Deviation 1.89 |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Change From Baseline in Respiratory Rate (RR) | RR max PBC | 3.14 breaths/min | Standard Deviation 4.6 |
Primary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Change from baseline in SBP and DBP (minimum post baseline change \[PBC\] and maximum PBC) are reported.
Time frame: Day 1 (baseline) through 246.9 weeks (maximum observed duration)
Population: As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP min PBC | -15.67 mmHg | Standard Deviation 18.01 |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP max PBC | 23.67 mmHg | Standard Deviation 11.93 |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP min PBC | -19.00 mmHg | Standard Deviation 21.63 |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP max PBC | 27.33 mmHg | Standard Deviation 5.69 |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP max PBC | 19.00 mmHg | Standard Deviation 5.57 |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP max PBC | 11.67 mmHg | Standard Deviation 4.93 |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP min PBC | -26.00 mmHg | Standard Deviation 10.82 |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP min PBC | -22.00 mmHg | Standard Deviation 10 |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP min PBC | -10.67 mmHg | Standard Deviation 9.07 |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP min PBC | -14.67 mmHg | Standard Deviation 11.55 |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP max PBC | 18.00 mmHg | Standard Deviation 9.64 |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP max PBC | 28.67 mmHg | Standard Deviation 20.82 |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP max PBC | 29.22 mmHg | Standard Deviation 15.78 |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP min PBC | -17.89 mmHg | Standard Deviation 9.58 |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP max PBC | 14.06 mmHg | Standard Deviation 12.75 |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP min PBC | -22.94 mmHg | Standard Deviation 12.73 |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP max PBC | 12.39 mmHg | Standard Deviation 9.3 |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP min PBC | -18.61 mmHg | Standard Deviation 11.05 |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP max PBC | 22.00 mmHg | Standard Deviation 19.16 |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP min PBC | -23.06 mmHg | Standard Deviation 20.48 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP max PBC | 21.10 mmHg | Standard Deviation 12.04 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP min PBC | -16.60 mmHg | Standard Deviation 10.4 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP min PBC | -21.45 mmHg | Standard Deviation 12.89 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP max PBC | 15.58 mmHg | Standard Deviation 9.69 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP min PBC | -17.60 mmHg | Standard Deviation 9.81 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP max PBC | 22.15 mmHg | Standard Deviation 17.39 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP max PBC | 12.63 mmHg | Standard Deviation 11.11 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP min PBC | -22.55 mmHg | Standard Deviation 13.35 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP max PBC | 19.83 mmHg | Standard Deviation 10.15 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP min PBC | -21.23 mmHg | Standard Deviation 12.29 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP max PBC | 23.55 mmHg | Standard Deviation 14.13 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP min PBC | -13.05 mmHg | Standard Deviation 7.21 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP max PBC | 22.95 mmHg | Standard Deviation 11.69 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP min PBC | -19.15 mmHg | Standard Deviation 10.28 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP min PBC | -26.40 mmHg | Standard Deviation 12.75 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP max PBC | 16.65 mmHg | Standard Deviation 9.46 |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP min PBC | -29.28 mmHg | Standard Deviation 19.19 |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP max PBC | 27.17 mmHg | Standard Deviation 21.63 |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP min PBC | -18.11 mmHg | Standard Deviation 8.98 |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP max PBC | 18.11 mmHg | Standard Deviation 9.33 |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP min PBC | -20.50 mmHg | Standard Deviation 9.79 |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP max PBC | 14.22 mmHg | Standard Deviation 12.18 |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP min PBC | -24.61 mmHg | Standard Deviation 10.92 |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP max PBC | 23.61 mmHg | Standard Deviation 11.27 |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP max PBC | 20.74 mmHg | Standard Deviation 15.31 |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP min PBC | -16.13 mmHg | Standard Deviation 9.33 |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP max PBC | 13.54 mmHg | Standard Deviation 10.01 |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP min PBC | -23.31 mmHg | Standard Deviation 12.88 |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP min PBC | -20.80 mmHg | Standard Deviation 11.87 |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP min PBC | -16.39 mmHg | Standard Deviation 9.94 |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP max PBC | 13.10 mmHg | Standard Deviation 8.98 |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP max PBC | 17.20 mmHg | Standard Deviation 10.51 |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP min PBC | -25.57 mmHg | Standard Deviation 13.99 |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP min PBC | -18.09 mmHg | Standard Deviation 9.69 |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP max PBC | 23.00 mmHg | Standard Deviation 13.18 |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP max PBC | 16.05 mmHg | Standard Deviation 10.06 |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP max PBC | 22.59 mmHg | Standard Deviation 15.69 |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP max PBC | 14.43 mmHg | Standard Deviation 9.01 |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP min PBC | -17.68 mmHg | Standard Deviation 12.15 |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP min PBC | -25.05 mmHg | Standard Deviation 16.86 |
Primary
Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters
Number of participants with at least 2-Grade shift from baseline in laboratory parameters are reported.
Time frame: Day 1 (baseline) through 246.9 weeks (maximum observed duration)
Population: As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received. Here, number analyzed (n) denotes number of participants analyzed for the specified laboratory parameter.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Blood bilirubin increased | 0 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Aspartate aminotransferase increased | 0 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Gamma Glutamyl Transferase increased | 0 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Creatinine increased | 1 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypoalbuminemia | 1 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Platelet count decreased | 0 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Neutrophil count decreased | 0 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyperglycemia | 0 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count increased | 0 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count decreased | 0 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | White blood cell decreased | 0 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Anaemia | 0 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypertriglyceridemia | 0 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lipase increased | 0 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Serum amylase increased | 0 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyponatremia | 1 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyponatremia | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Aspartate aminotransferase increased | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypertriglyceridemia | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Gamma Glutamyl Transferase increased | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count decreased | 1 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Creatinine increased | 1 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Blood bilirubin increased | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypoalbuminemia | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | White blood cell decreased | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Platelet count decreased | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lipase increased | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Neutrophil count decreased | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Anaemia | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count increased | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Serum amylase increased | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyperglycemia | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyponatremia | 1 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyperglycemia | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Serum amylase increased | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Aspartate aminotransferase increased | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Blood bilirubin increased | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lipase increased | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypertriglyceridemia | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Anaemia | 1 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | White blood cell decreased | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count decreased | 1 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count increased | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Neutrophil count decreased | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Platelet count decreased | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypoalbuminemia | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Creatinine increased | 1 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Gamma Glutamyl Transferase increased | 0 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypertriglyceridemia | 0 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Creatinine increased | 1 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count increased | 0 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lipase increased | 0 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Gamma Glutamyl Transferase increased | 1 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyperglycemia | 0 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Platelet count decreased | 0 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count decreased | 4 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | White blood cell decreased | 0 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyponatremia | 2 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypoalbuminemia | 6 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Serum amylase increased | 0 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Neutrophil count decreased | 0 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Aspartate aminotransferase increased | 0 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Blood bilirubin increased | 0 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Anaemia | 2 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lipase increased | 0 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyperglycemia | 0 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count decreased | 4 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Gamma Glutamyl Transferase increased | 4 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Blood bilirubin increased | 0 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyponatremia | 3 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Aspartate aminotransferase increased | 0 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Creatinine increased | 4 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypertriglyceridemia | 0 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypoalbuminemia | 3 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Platelet count decreased | 1 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Anaemia | 1 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Serum amylase increased | 0 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Neutrophil count decreased | 0 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | White blood cell decreased | 0 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count increased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count increased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyponatremia | 3 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Anaemia | 2 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyperglycemia | 3 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypertriglyceridemia | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Platelet count decreased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | White blood cell decreased | 1 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Gamma Glutamyl Transferase increased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count decreased | 5 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lipase increased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypoalbuminemia | 6 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Aspartate aminotransferase increased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Blood bilirubin increased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Serum amylase increased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Neutrophil count decreased | 1 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Creatinine increased | 4 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyponatremia | 5 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count increased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Blood bilirubin increased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypertriglyceridemia | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lipase increased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypoalbuminemia | 6 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Gamma Glutamyl Transferase increased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Serum amylase increased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Platelet count decreased | 1 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | White blood cell decreased | 1 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Anaemia | 1 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Neutrophil count decreased | 2 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count decreased | 7 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyperglycemia | 4 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Creatinine increased | 4 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Aspartate aminotransferase increased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Aspartate aminotransferase increased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypertriglyceridemia | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count decreased | 8 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Gamma Glutamyl Transferase increased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count increased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypoalbuminemia | 6 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyperglycemia | 3 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyponatremia | 5 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lipase increased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Platelet count decreased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Creatinine increased | 8 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Serum amylase increased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Blood bilirubin increased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Anaemia | 2 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | White blood cell decreased | 2 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Neutrophil count decreased | 1 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Creatinine increased | 2 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Aspartate aminotransferase increased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Blood bilirubin increased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lipase increased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Gamma Glutamyl Transferase increased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypertriglyceridemia | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyperglycemia | 5 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Anaemia | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | White blood cell decreased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count decreased | 5 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count increased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Neutrophil count decreased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Platelet count decreased | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyponatremia | 1 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypoalbuminemia | 2 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Serum amylase increased | 0 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyperglycemia | 1 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Gamma Glutamyl Transferase increased | 0 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Neutrophil count decreased | 9 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Anaemia | 1 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Blood bilirubin increased | 3 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Creatinine increased | 4 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lipase increased | 5 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count decreased | 5 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | White blood cell decreased | 7 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Serum amylase increased | 4 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypoalbuminemia | 2 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypertriglyceridemia | 3 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count increased | 1 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Aspartate aminotransferase increased | 2 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyponatremia | 4 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Platelet count decreased | 2 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Anaemia | 2 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | White blood cell decreased | 6 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Gamma Glutamyl Transferase increased | 0 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count increased | 0 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Neutrophil count decreased | 11 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyponatremia | 2 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Platelet count decreased | 2 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypertriglyceridemia | 3 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyperglycemia | 5 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Aspartate aminotransferase increased | 2 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypoalbuminemia | 2 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lipase increased | 10 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Creatinine increased | 2 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Blood bilirubin increased | 2 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Serum amylase increased | 6 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count decreased | 4 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count increased | 0 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Aspartate aminotransferase increased | 0 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypertriglyceridemia | 0 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count decreased | 6 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyperglycemia | 0 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Serum amylase increased | 0 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Creatinine increased | 0 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | White blood cell decreased | 0 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyponatremia | 0 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Neutrophil count decreased | 0 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Anaemia | 2 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lipase increased | 5 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Platelet count decreased | 1 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Blood bilirubin increased | 7 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypoalbuminemia | 9 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Gamma Glutamyl Transferase increased | 0 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Gamma Glutamyl Transferase increased | 0 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | White blood cell decreased | 2 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypertriglyceridemia | 0 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Aspartate aminotransferase increased | 0 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count increased | 0 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Platelet count decreased | 0 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypoalbuminemia | 2 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lipase increased | 6 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyperglycemia | 0 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Serum amylase increased | 0 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Creatinine increased | 0 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Blood bilirubin increased | 7 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Anaemia | 2 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count decreased | 3 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyponatremia | 0 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Neutrophil count decreased | 1 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lipase increased | 7 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | White blood cell decreased | 4 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypertriglyceridemia | 0 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyperglycemia | 0 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Blood bilirubin increased | 3 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Neutrophil count decreased | 1 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Creatinine increased | 0 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyponatremia | 0 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count increased | 0 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count decreased | 7 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Gamma Glutamyl Transferase increased | 0 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Anaemia | 0 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Serum amylase increased | 0 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Platelet count decreased | 0 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Aspartate aminotransferase increased | 0 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypoalbuminemia | 6 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Anaemia | 2 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count decreased | 8 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyponatremia | 0 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hyperglycemia | 0 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Gamma Glutamyl Transferase increased | 0 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Aspartate aminotransferase increased | 0 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Blood bilirubin increased | 6 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | White blood cell decreased | 1 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Neutrophil count decreased | 1 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lymphocyte count increased | 2 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypertriglyceridemia | 0 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Serum amylase increased | 0 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Hypoalbuminemia | 5 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Creatinine increased | 0 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Lipase increased | 5 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Platelet count decreased | 3 Participants |
Primary
Number of Participants With Dose Limiting Toxicities (DLTs)
DLT: Any study drug related Grade (G) 3 or higher toxicity that occurred during DLT evaluation period including: any G\>=3 noninfectious colitis/pneumonitis, liver transaminase elevation (TE) \>=5 but =\<8 upper limit of normal (ULN), any G4 immune-mediated AE (imAE)/immune-related AE (irAE), any G\>=3 clinically significant non-hematologic toxicity, TE \>8 ULN or total bilirubin (TBL) \>5 ULN, increase in AST or ALT \>=3 ULN along with TBL \>=2 ULN, thrombocytopenia (G3/4 associated with G3/higher hemorrhage, G3 that did not improve by at least 1 grade within 7 days, and G4), G4 febrile neutropenia (FN), G3 FN of \>=5 days and G3 FN regardless of duration, G4 neutropenia of \>7 days, G3/4 neutropenia not associated with fever/systemic infection, and anemia (G3 and G4).
Time frame: From Day 1 to 28 days after the first dose of study drugs
Population: The DLT-Evaluable population included all participants enrolled in the dose-escalation part who received at least 1 dose of study drugs and completed the safety follow-up through the DLT-evaluation period or experienced any DLT during the DLT-evaluation period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
Primary
Number of Participants With Notable Change in QTcF and QTcB From Baseline
Participants who had notable QTcF and QTcB interval change from baseline are reported.
Time frame: Day 1 (baseline) through 246.9 weeks (maximum observed duration)
Population: As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who were evaluable for this outcome.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>30 msec | 1 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>60 msec | 0 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>60 msec | 0 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>30 msec | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>30 msec | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>30 msec | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>60 msec | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>60 msec | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>30 msec | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>60 msec | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>60 msec | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>30 msec | 0 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>60 msec | 1 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>30 msec | 2 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>60 msec | 1 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>30 msec | 3 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>60 msec | 0 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>30 msec | 1 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>30 msec | 2 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>60 msec | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>60 msec | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>30 msec | 6 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>60 msec | 1 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>30 msec | 5 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>30 msec | 5 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>60 msec | 2 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>60 msec | 3 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>30 msec | 5 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>60 msec | 1 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>30 msec | 2 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>60 msec | 1 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>30 msec | 4 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>60 msec | 1 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>30 msec | 2 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>30 msec | 3 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>60 msec | 1 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>60 msec | 0 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>60 msec | 0 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>30 msec | 1 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>30 msec | 1 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>30 msec | 6 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>60 msec | 0 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>60 msec | 0 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>30 msec | 2 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>60 msec | 1 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>30 msec | 4 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>60 msec | 1 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>30 msec | 3 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>30 msec | 3 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>60 msec | 2 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>30 msec | 8 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>60 msec | 1 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>30 msec | 5 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>60 msec | 0 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>30 msec | 9 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>60 msec | 0 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>60 msec | 1 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>60 msec | 1 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcB>30 msec | 6 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Notable Change in QTcF and QTcB From Baseline | QTcF>30 msec | 5 Participants |
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. Any TEAEs data is inclusive of both serious and other adverse events (non-serious).
Time frame: Day 1 through 246.9 weeks (maximum observed duration)
Population: As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TEAEs | 3 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TESAEs | 1 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TEAEs | 3 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TESAEs | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TEAEs | 3 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TESAEs | 1 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TEAEs | 18 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TESAEs | 8 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TESAEs | 4 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TEAEs | 17 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TESAEs | 11 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TEAEs | 39 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TEAEs | 40 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TESAEs | 16 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TEAEs | 39 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TESAEs | 17 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TEAEs | 20 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TESAEs | 7 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TESAEs | 10 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TEAEs | 18 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TEAEs | 18 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TESAEs | 11 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TESAEs | 10 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TEAEs | 39 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TESAEs | 5 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TEAEs | 41 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TEAEs | 44 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TESAEs | 9 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TESAEs | 11 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TEAEs | 36 Participants |
Primary
Percentage of Participants With Objective Response (OR) in Exploration Cohorts C1A and C1B
The OR is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST V 1.1) guidelines. The CR is defined as disappearance of all target and non-target lesions and normalization of tumor marker level lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in between.
Time frame: Baseline (Days -28 to -1) through 54.8 months (maximum observed duration)
Population: The ITT population included participants who were randomized and were analyzed according to the treatment group they were randomized to.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Percentage of Participants With Objective Response (OR) in Exploration Cohorts C1A and C1B | 0 Percentage of Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Percentage of Participants With Objective Response (OR) in Exploration Cohorts C1A and C1B | 0 Percentage of Participants |
Secondary
DoR in Exploration Cohorts (C1A, C1B, C2A, and C2B)
The DoR is defined as the duration from the first documentation of OR (confirmed CR or confirmed PR) to the first documented PD based on RECIST v1.1 or death due to any cause, whichever occurred first. The CR is defined as disappearance of all target and non-target lesions and normalization of tumor marker level lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in between. The PD is defined as at least a 20% increase in the sum of diameters of target lesions or unequivocal progression of existing non-target lesions, taking as reference the smallest sum on study and appearance of one or more new lesions. The DoR was evaluated using Kaplan-Meier method.
Time frame: Baseline (-28 to -1 day) through 54.8 months (maximum observed duration)
Population: The ITT population included participants who were randomized and were analyzed according to the treatment group they were randomized to. Participants who had achieved OR were evaluated for this outcome.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | DoR in Exploration Cohorts (C1A, C1B, C2A, and C2B) | 32.1 Weeks |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | DoR in Exploration Cohorts (C1A, C1B, C2A, and C2B) | 24.1 Weeks |
Secondary
Duration of Response (DoR)
The DoR is defined as the duration from the first documentation of OR (confirmed CR or confirmed PR) to the first documented disease progression (PD) based on RECIST v1.1 or death due to any cause, whichever occurred first. The CR is defined as disappearance of all target and non-target lesions and normalization of tumor marker level lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in between. The PD is defined as at least a 20% increase in the sum of diameters of target lesions or unequivocal progression of existing non-target lesions, taking as reference the smallest sum on study and appearance of one or more new lesions. The DoR was evaluated using Kaplan-Meier method.
Time frame: Baseline (-28 to -1 day) through 54.8 months (maximum observed duration)
Population: As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received. Participants who had achieved OR were evaluated for this outcome.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Duration of Response (DoR) | 16.1 Weeks |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Duration of Response (DoR) | 68.1 Weeks |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Duration of Response (DoR) | 22.9 Weeks |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Duration of Response (DoR) | 66.1 Weeks |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Duration of Response (DoR) | 72.3 Weeks |
Secondary
Maximum Observed Serum Concentration (Cmax) of Monalizumab
Serum Cmax of monalizumab at pre-dose and end of infusion are reported.
Time frame: Day 85: Pre-dose and end of infusion (within 10 minutes) after cohort specific infusions
Population: Pharmacokinetic (PK) evaluable population included participants who received at least 1 dose of durvalumab and/or monalizumab and had at least 1 post-treatment sample available. Number of participants analyzed (N) denotes those participants who had adequate PK sample available for analysis. Data for dose-escalation Cohort 4 and dose-expansion Cohorts (MSS-CRC, Ovarian, Endometrial MSS and NSCLC) were combined in a single arm/group to avoid increased variability due to smaller cohort sizes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Maximum Observed Serum Concentration (Cmax) of Monalizumab | 7.85 µg/mL | — |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Maximum Observed Serum Concentration (Cmax) of Monalizumab | 43.62 µg/mL | Standard Deviation 12.54 |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Maximum Observed Serum Concentration (Cmax) of Monalizumab | 144.88 µg/mL | — |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Maximum Observed Serum Concentration (Cmax) of Monalizumab | 315.74 µg/mL | Standard Deviation 129.08 |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Maximum Observed Serum Concentration (Cmax) of Monalizumab | 245.18 µg/mL | Standard Deviation 142.35 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Maximum Observed Serum Concentration (Cmax) of Monalizumab | 304.48 µg/mL | Standard Deviation 66.75 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Maximum Observed Serum Concentration (Cmax) of Monalizumab | 281.53 µg/mL | Standard Deviation 155.57 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Maximum Observed Serum Concentration (Cmax) of Monalizumab | 346.85 µg/mL | Standard Deviation 91.06 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Maximum Observed Serum Concentration (Cmax) of Monalizumab | 388.60 µg/mL | Standard Deviation 194.64 |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Maximum Observed Serum Concentration (Cmax) of Monalizumab | 289.25 µg/mL | Standard Deviation 194.59 |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Maximum Observed Serum Concentration (Cmax) of Monalizumab | 409.93 µg/mL | Standard Deviation 175.43 |
Secondary
Minimum Observed Serum Concentration (Cmin) of Monalizumab
Serum Cmin of monalizumab at pre-dose and end of infusion are reported.
Time frame: Day 85: Pre-dose and end of infusion (within 10 minutes) after cohort specific infusions
Population: Pharmacokinetic evaluable population included participants who received at least 1 dose of durvalumab and/or monalizumab and had at least 1 post-treatment sample available. Number of participants analyzed (N) denotes those participants who had adequate PK sample available for analysis. Data for dose-escalation Cohort 4 and dose-expansion Cohorts (MSS-CRC, Ovarian, Endometrial MSS and NSCLC) were combined in a single arm/group to avoid increased variability due to smaller cohort sizes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Minimum Observed Serum Concentration (Cmin) of Monalizumab | 7.45 µg/mL | — |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Minimum Observed Serum Concentration (Cmin) of Monalizumab | 18.16 µg/mL | Standard Deviation 6.7 |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Minimum Observed Serum Concentration (Cmin) of Monalizumab | 92.55 µg/mL | — |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Minimum Observed Serum Concentration (Cmin) of Monalizumab | 145.04 µg/mL | Standard Deviation 76.34 |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Minimum Observed Serum Concentration (Cmin) of Monalizumab | 67.75 µg/mL | Standard Deviation 57.82 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Minimum Observed Serum Concentration (Cmin) of Monalizumab | 141.39 µg/mL | Standard Deviation 57.01 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Minimum Observed Serum Concentration (Cmin) of Monalizumab | 109.18 µg/mL | Standard Deviation 45.54 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Minimum Observed Serum Concentration (Cmin) of Monalizumab | 129.59 µg/mL | Standard Deviation 45.72 |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Minimum Observed Serum Concentration (Cmin) of Monalizumab | 172.90 µg/mL | Standard Deviation 84.55 |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Minimum Observed Serum Concentration (Cmin) of Monalizumab | 148.05 µg/mL | Standard Deviation 70.23 |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Minimum Observed Serum Concentration (Cmin) of Monalizumab | 185.60 µg/mL | Standard Deviation 105.68 |
Secondary
Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies
The HLA-E expression in pre-treatment tumor biopsies is reported.
Time frame: Screening (Days -28 to -1)
Population: As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Endothelium | 3 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Carcinoma | 3 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Lymphocyte | 3 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Endothelium | 3 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Lymphocyte | 3 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Carcinoma | 3 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Endothelium | 3 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Carcinoma | 3 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Lymphocyte | 3 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Lymphocyte | 12 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Carcinoma | 12 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Endothelium | 13 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Endothelium | 13 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Carcinoma | 13 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Lymphocyte | 13 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Lymphocyte | 30 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Carcinoma | 28 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Endothelium | 30 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Endothelium | 37 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Carcinoma | 36 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Lymphocyte | 37 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Lymphocyte | 32 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Carcinoma | 32 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Endothelium | 33 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Carcinoma | 16 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Lymphocyte | 17 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Endothelium | 17 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Lymphocyte | 16 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Carcinoma | 16 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Endothelium | 16 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Lymphocyte | 17 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Carcinoma | 17 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Endothelium | 17 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Endothelium | 30 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Lymphocyte | 29 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Carcinoma | 30 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Lymphocyte | 32 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Carcinoma | 33 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Endothelium | 31 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Carcinoma | 34 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Endothelium | 34 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Lymphocyte | 34 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Lymphocyte | 32 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Endothelium | 32 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Human Leukocyte Antigen (HLA)-E Expression in Pretreatment Tumor Biopsies | HLA-E Carcinoma | 32 Participants |
Secondary
Number of Participants With Positive ADA to Cetuximab
Number of participants with positive ADA to cetuximab are reported. Persistent positive is defined as positive at \>= 2 post-baseline assessments (with \>=16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at \>= 2 post-baseline assessments (with \<16 weeks between first and last positive). Treatment-boosted ADA is defined as baseline ADA titer that was boosted to a 4-fold or higher level following drug administration. Treatment-emergent ADA is defined as the sum of treatment-induced ADA (post-baseline positive only) and treatment-boosted ADA.
Time frame: Day 1 through 54.8 months (Day 1 of Weeks 1, 5, 9 [if EOT occurred], and 13, and 30 days after the last dose of monalizumab)
Population: As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who had post-baseline ADA results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Cetuximab | Persistent Positive | 0 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Cetuximab | Transient Positive | 0 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Cetuximab | Treatment-boosted ADA | 0 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Cetuximab | Treatment-emergent ADA | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Cetuximab | Persistent Positive | 1 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Cetuximab | Treatment-emergent ADA | 1 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Cetuximab | Transient Positive | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Cetuximab | Treatment-boosted ADA | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Cetuximab | Treatment-emergent ADA | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Cetuximab | Transient Positive | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Cetuximab | Treatment-boosted ADA | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Cetuximab | Persistent Positive | 0 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Cetuximab | Persistent Positive | 0 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Cetuximab | Transient Positive | 0 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Cetuximab | Treatment-emergent ADA | 0 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Cetuximab | Treatment-boosted ADA | 0 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Cetuximab | Treatment-emergent ADA | 0 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Cetuximab | Treatment-boosted ADA | 0 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Cetuximab | Transient Positive | 0 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Cetuximab | Persistent Positive | 0 Participants |
Secondary
Number of Participants With Positive ADA to Durvalumab
Number of participants with positive ADA to monalizumab are reported. Persistent positive is defined as positive at \>= 2 post-baseline assessments (with \>= 16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at \>= 2 post-baseline assessments (with \<16 weeks between first and last positive). Treatment-boosted ADA is defined as baseline ADA titer that was boosted to a 4-fold or higher level following drug administration. Treatment-emergent ADA is defined as the sum of treatment-induced ADA (post-baseline positive only) and treatment-boosted ADA.
Time frame: Day 1 through 54.8 months (Day 1 of Weeks 1, 5, 13, and 25, and 90 days after the last dose of monalizumab)
Population: As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who had post-baseline ADA results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Durvalumab | Transient Positive | 0 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Durvalumab | Treatment-boosted ADA | 0 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Durvalumab | Treatment-emergent ADA | 0 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Durvalumab | Persistent Positive | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Durvalumab | Transient Positive | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Durvalumab | Persistent Positive | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Durvalumab | Treatment-emergent ADA | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Durvalumab | Treatment-boosted ADA | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Durvalumab | Treatment-boosted ADA | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Durvalumab | Transient Positive | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Durvalumab | Persistent Positive | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Durvalumab | Treatment-emergent ADA | 0 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Durvalumab | Persistent Positive | 0 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Durvalumab | Treatment-boosted ADA | 0 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Durvalumab | Transient Positive | 0 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Durvalumab | Treatment-emergent ADA | 0 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Durvalumab | Transient Positive | 1 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Durvalumab | Treatment-emergent ADA | 1 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Durvalumab | Treatment-boosted ADA | 0 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Positive ADA to Durvalumab | Persistent Positive | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With Positive ADA to Durvalumab | Treatment-boosted ADA | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With Positive ADA to Durvalumab | Treatment-emergent ADA | 1 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With Positive ADA to Durvalumab | Transient Positive | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With Positive ADA to Durvalumab | Persistent Positive | 1 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With Positive ADA to Durvalumab | Transient Positive | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With Positive ADA to Durvalumab | Treatment-emergent ADA | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With Positive ADA to Durvalumab | Treatment-boosted ADA | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With Positive ADA to Durvalumab | Persistent Positive | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With Positive ADA to Durvalumab | Transient Positive | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With Positive ADA to Durvalumab | Treatment-boosted ADA | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With Positive ADA to Durvalumab | Persistent Positive | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With Positive ADA to Durvalumab | Treatment-emergent ADA | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With Positive ADA to Durvalumab | Transient Positive | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With Positive ADA to Durvalumab | Persistent Positive | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With Positive ADA to Durvalumab | Treatment-boosted ADA | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With Positive ADA to Durvalumab | Treatment-emergent ADA | 0 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With Positive ADA to Durvalumab | Treatment-boosted ADA | 0 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With Positive ADA to Durvalumab | Treatment-emergent ADA | 0 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With Positive ADA to Durvalumab | Transient Positive | 0 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With Positive ADA to Durvalumab | Persistent Positive | 0 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With Positive ADA to Durvalumab | Persistent Positive | 0 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With Positive ADA to Durvalumab | Treatment-emergent ADA | 0 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With Positive ADA to Durvalumab | Treatment-boosted ADA | 0 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With Positive ADA to Durvalumab | Transient Positive | 0 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Positive ADA to Durvalumab | Treatment-emergent ADA | 0 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Positive ADA to Durvalumab | Treatment-boosted ADA | 0 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Positive ADA to Durvalumab | Transient Positive | 0 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Positive ADA to Durvalumab | Persistent Positive | 0 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Positive ADA to Durvalumab | Treatment-boosted ADA | 0 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Positive ADA to Durvalumab | Transient Positive | 0 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Positive ADA to Durvalumab | Persistent Positive | 0 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Positive ADA to Durvalumab | Treatment-emergent ADA | 0 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Positive ADA to Durvalumab | Transient Positive | 0 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Positive ADA to Durvalumab | Treatment-emergent ADA | 0 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Positive ADA to Durvalumab | Treatment-boosted ADA | 0 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Positive ADA to Durvalumab | Persistent Positive | 0 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Positive ADA to Durvalumab | Treatment-emergent ADA | 0 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Positive ADA to Durvalumab | Persistent Positive | 0 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Positive ADA to Durvalumab | Transient Positive | 0 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Positive ADA to Durvalumab | Treatment-boosted ADA | 0 Participants |
Secondary
Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab
Number of participants with positive ADA to monalizumab are reported. Persistent positive is defined as positive at \>= 2 post-baseline assessments (with \>=16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at \>= 2 post-baseline assessments (with \<16 weeks between first and last positive). Treatment-boosted ADA is defined as baseline ADA titer that was boosted to a 4-fold or higher level following drug administration. Treatment-emergent ADA is defined as the sum of treatment-induced ADA (post-baseline positive only) and treatment-boosted ADA.
Time frame: Day 1 through 54.8 months (Day 1 of Weeks 1, 5, 13, and 25, and 90 days after the last dose of monalizumab)
Population: As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who had post-baseline ADA results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-boosted ADA | 0 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Transient Positive | 0 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-emergent ADA | 0 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Persistent Positive | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Persistent Positive | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-boosted ADA | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Transient Positive | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-emergent ADA | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-boosted ADA | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-emergent ADA | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Transient Positive | 0 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Persistent Positive | 0 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-emergent ADA | 3 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Persistent Positive | 2 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Transient Positive | 1 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-boosted ADA | 0 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-emergent ADA | 0 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Persistent Positive | 0 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-boosted ADA | 0 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Transient Positive | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Transient Positive | 1 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Persistent Positive | 10 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-emergent ADA | 11 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-boosted ADA | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-boosted ADA | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Transient Positive | 2 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-emergent ADA | 7 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Persistent Positive | 5 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-emergent ADA | 5 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Persistent Positive | 4 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Transient Positive | 1 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-boosted ADA | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Transient Positive | 2 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Persistent Positive | 2 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-boosted ADA | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-emergent ADA | 4 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-emergent ADA | 0 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Transient Positive | 0 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-boosted ADA | 0 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Persistent Positive | 0 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-boosted ADA | 0 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-emergent ADA | 1 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Transient Positive | 0 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Persistent Positive | 1 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Transient Positive | 1 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-boosted ADA | 0 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-emergent ADA | 6 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Persistent Positive | 5 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Persistent Positive | 5 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-emergent ADA | 6 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-boosted ADA | 0 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Transient Positive | 1 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Persistent Positive | 3 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Transient Positive | 2 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-boosted ADA | 0 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-emergent ADA | 5 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Transient Positive | 0 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-emergent ADA | 5 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Treatment-boosted ADA | 0 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Monalizumab | Persistent Positive | 5 Participants |
Secondary
Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies
Number of participants with PD-L1 expression in pre-treatment tumor biopsies is reported. The participants were stratified into four categories: tumor cells (TC) \>= 25%, TC\<25%, TC\>=1%, and TC\<1%, based on the historical use of PD-L1 cutoffs.
Time frame: Screening (Days -28 to -1)
Population: As-treated population included participant who received any study drugs and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants for whom PD-L1 testing was performed and number analyzed (n) denotes those participants for whom PD-L1 status was obtained.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=1% | 1 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<25% | 3 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<1% | 2 Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=25% | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=25% | 0 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=1% | 1 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<25% | 3 Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<1% | 2 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=1% | 1 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<1% | 2 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<25% | 3 Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=25% | 0 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<1% | 7 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=25% | 2 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<25% | 11 Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=1% | 6 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<1% | 12 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=25% | 1 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=1% | 2 Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<25% | 13 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<25% | 29 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=25% | 0 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<1% | 24 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=1% | 5 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=1% | 22 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<25% | 32 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<1% | 15 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=25% | 5 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<1% | 16 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=25% | 1 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<25% | 31 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=1% | 16 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<25% | 10 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=25% | 6 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=1% | 8 Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<1% | 8 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<1% | 13 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<25% | 16 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=1% | 3 Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=25% | 0 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=1% | 0 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<1% | 18 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<25% | 18 Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=25% | 0 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<25% | 31 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=1% | 5 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<1% | 26 Participants |
| Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=25% | 0 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=25% | 1 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<1% | 26 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=1% | 7 Participants |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<25% | 32 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=25% | 1 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<25% | 35 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=1% | 7 Participants |
| Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<1% | 29 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<25% | 32 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC<1% | 27 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=1% | 5 Participants |
| Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W | Number of Participants With Programmed Death Ligand 1 (PD-L1) Expression in Pretreatment Tumor Biopsies | TC>=25% | 0 Participants |
Secondary
Overall Survival
The overall survival is defined as the time from the start of study treatment until death due to any cause. The overall survival was estimated using Kaplan-Meier method.
Time frame: Baseline (-28 to -1 day) through 54.8 months (maximum observed duration)
Population: As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Overall Survival | 15.1 Months |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Overall Survival | 20.1 Months |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Overall Survival | NA Months |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Overall Survival | 8.1 Months |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Overall Survival | 13.4 Months |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Overall Survival | 10.6 Months |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Overall Survival | 16.7 Months |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Overall Survival | 11.0 Months |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Overall Survival | 8.8 Months |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Overall Survival | 25.6 Months |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Overall Survival | 29.6 Months |
Secondary
Overall Survival in Exploration Cohorts (C1A, C1B, C2A, and C2B)
The overall survival is defined as the time from the start of study treatment until death due to any cause. The overall survival was estimated using Kaplan-Meier method.
Time frame: Baseline (-28 to -1 day) through 54.8 weeks (maximum observed duration)
Population: The ITT population included participants who were randomized and the participants were analyzed according to the treatment group they were randomized to.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Overall Survival in Exploration Cohorts (C1A, C1B, C2A, and C2B) | 10.3 Months |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Overall Survival in Exploration Cohorts (C1A, C1B, C2A, and C2B) | 8.9 Months |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Overall Survival in Exploration Cohorts (C1A, C1B, C2A, and C2B) | 14.6 Months |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Overall Survival in Exploration Cohorts (C1A, C1B, C2A, and C2B) | 14.6 Months |
Secondary
Percentage of Participants With DC in Exploration Cohorts (C1A, C1B, C2A, and C2B)
The DC is defined as best overall response of confirmed CR, confirmed PR, or SD based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and normalization of tumor marker level lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in between. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. Participants with SD were included in the DC if they maintained SD for \>= 8 weeks from start of treatment. The DCR16 and DCR24 are reported (participants with SD \>= 16 weeks and \>=24 weeks).
Time frame: Baseline (-28 to -1 day) through 54.8 months (maximum observed duration)
Population: The ITT population included participants who were randomized and were analyzed according to the treatment group they were randomized to.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Percentage of Participants With DC in Exploration Cohorts (C1A, C1B, C2A, and C2B) | DCR16 | 17.5 Percentage of Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Percentage of Participants With DC in Exploration Cohorts (C1A, C1B, C2A, and C2B) | DCR24 | 10.0 Percentage of Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Percentage of Participants With DC in Exploration Cohorts (C1A, C1B, C2A, and C2B) | DCR24 | 7.3 Percentage of Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Percentage of Participants With DC in Exploration Cohorts (C1A, C1B, C2A, and C2B) | DCR16 | 34.1 Percentage of Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Percentage of Participants With DC in Exploration Cohorts (C1A, C1B, C2A, and C2B) | DCR16 | 59.1 Percentage of Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Percentage of Participants With DC in Exploration Cohorts (C1A, C1B, C2A, and C2B) | DCR24 | 52.3 Percentage of Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Percentage of Participants With DC in Exploration Cohorts (C1A, C1B, C2A, and C2B) | DCR16 | 56.8 Percentage of Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Percentage of Participants With DC in Exploration Cohorts (C1A, C1B, C2A, and C2B) | DCR24 | 45.9 Percentage of Participants |
Secondary
Percentage of Participants With Disease Control (DC)
The DC is defined as best overall response of confirmed CR, confirmed PR, or stable disease (SD) based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and normalization of tumor marker level lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in between. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. Participants with SD were included in the DC if they maintained SD for \>= 8 weeks from start of treatment. The DCR16 and DCR24 are reported (participants with SD \>= 16 weeks and \>=24 weeks).
Time frame: Baseline (-28 to -1 day) through 54.8 months (maximum observed duration)
Population: As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Percentage of Participants With Disease Control (DC) | DCR16 | 0 Percentage of Participants |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Percentage of Participants With Disease Control (DC) | DCR24 | 0 Percentage of Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Percentage of Participants With Disease Control (DC) | DCR16 | 33.3 Percentage of Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Percentage of Participants With Disease Control (DC) | DCR24 | 0 Percentage of Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Percentage of Participants With Disease Control (DC) | DCR16 | 0 Percentage of Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Percentage of Participants With Disease Control (DC) | DCR24 | 0 Percentage of Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Percentage of Participants With Disease Control (DC) | DCR16 | 22.2 Percentage of Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Percentage of Participants With Disease Control (DC) | DCR24 | 0 Percentage of Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Percentage of Participants With Disease Control (DC) | DCR16 | 27.8 Percentage of Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Percentage of Participants With Disease Control (DC) | DCR24 | 11.1 Percentage of Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Percentage of Participants With Disease Control (DC) | DCR24 | 17.5 Percentage of Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Percentage of Participants With Disease Control (DC) | DCR16 | 30 Percentage of Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Percentage of Participants With Disease Control (DC) | DCR24 | 15 Percentage of Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Percentage of Participants With Disease Control (DC) | DCR16 | 30 Percentage of Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Percentage of Participants With Disease Control (DC) | DCR16 | 25 Percentage of Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Percentage of Participants With Disease Control (DC) | DCR24 | 12.5 Percentage of Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Percentage of Participants With Disease Control (DC) | DCR16 | 40 Percentage of Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Percentage of Participants With Disease Control (DC) | DCR24 | 25 Percentage of Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Percentage of Participants With Disease Control (DC) | DCR16 | 77.8 Percentage of Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Percentage of Participants With Disease Control (DC) | DCR24 | 66.7 Percentage of Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Percentage of Participants With Disease Control (DC) | DCR16 | 88.9 Percentage of Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Percentage of Participants With Disease Control (DC) | DCR24 | 77.8 Percentage of Participants |
Secondary
Percentage of Participants With OR
The OR is defined as best overall response of CR or confirmed PR according to RECIST V 1.1 guidelines. The CR is defined as disappearance of all target and non-target lesions and normalization of tumor marker level lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in between.
Time frame: Baseline (Days -28 to -1) through 54.8 months (maximum observed duration)
Population: As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Percentage of Participants With OR | 0 Percentage of Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Percentage of Participants With OR | 0 Percentage of Participants |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Percentage of Participants With OR | 0 Percentage of Participants |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Percentage of Participants With OR | 0 Percentage of Participants |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Percentage of Participants With OR | 0 Percentage of Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Percentage of Participants With OR | 7.5 Percentage of Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Percentage of Participants With OR | 5.0 Percentage of Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Percentage of Participants With OR | 0 Percentage of Participants |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Percentage of Participants With OR | 10.0 Percentage of Participants |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Percentage of Participants With OR | 44.4 Percentage of Participants |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Percentage of Participants With OR | 72.2 Percentage of Participants |
Secondary
Percentage of Participants With OR in Exploration Cohorts C2A and C2B
The OR is defined as best overall response of confirmed CR or confirmed PR according to RECIST V 1.1 guidelines. The CR is defined as disappearance of all target and non-target lesions and normalization of tumor marker level lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in between.
Time frame: Baseline (-28 to -1 day) through 54.8 months (maximum observed duration)
Population: The ITT population included participants who were randomized and were analyzed according to the treatment group they were randomized to.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Percentage of Participants With OR in Exploration Cohorts C2A and C2B | 11.4 Percentage of Participants |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Percentage of Participants With OR in Exploration Cohorts C2A and C2B | 5.4 Percentage of Participants |
Secondary
Progression-Free Survival (PFS)
The PFS is defined as the time from the start of study treatment until the first documentation of PD based on RECIST v1.1 or death due to any cause, whichever occurred first. The PD is defined as at least a 20% increase in the sum of diameters of target lesions or unequivocal progression of existing non-target lesions, taking as reference the smallest sum on study and appearance of one or more new lesions. The PFS was estimated using Kaplan-Meier method.
Time frame: Baseline (-28 to -1 day) through 54.8 months (maximum observed duration)
Population: As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Progression-Free Survival (PFS) | 1.8 Months |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Progression-Free Survival (PFS) | 1.9 Months |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Progression-Free Survival (PFS) | 1.9 Months |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Progression-Free Survival (PFS) | 2.0 Months |
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Progression-Free Survival (PFS) | 1.8 Months |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Progression-Free Survival (PFS) | 1.9 Months |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Progression-Free Survival (PFS) | 1.8 Months |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Progression-Free Survival (PFS) | 1.8 Months |
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Progression-Free Survival (PFS) | 1.9 Months |
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Progression-Free Survival (PFS) | 10.9 Months |
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | Progression-Free Survival (PFS) | 14.7 Months |
Secondary
Progression-Free Survival (PFS) in Exploration Cohorts (C1A, C1B, C2A, and C2B)
The PFS is defined as the time from the start of study treatment until the first documentation of PD based on RECIST v1.1 or death due to any cause, whichever occurred first. The PD is defined as at least a 20% increase in the sum of diameters of target lesions or unequivocal progression of existing non-target lesions, taking as reference the smallest sum on study and appearance of one or more new lesions. The PFS was estimated using Kaplan-Meier method.
Time frame: Baseline (-28 to -1 day) through 54.8 months (maximum observed duration)
Population: The ITT population included participants who were randomized and were analyzed according to the treatment group they were randomized to.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Progression-Free Survival (PFS) in Exploration Cohorts (C1A, C1B, C2A, and C2B) | 1.8 Months |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Progression-Free Survival (PFS) in Exploration Cohorts (C1A, C1B, C2A, and C2B) | 2.0 Months |
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Progression-Free Survival (PFS) in Exploration Cohorts (C1A, C1B, C2A, and C2B) | 5.3 Months |
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Progression-Free Survival (PFS) in Exploration Cohorts (C1A, C1B, C2A, and C2B) | 4.4 Months |
Secondary
Serum Concentration of Cetuximab
Serum concentration of cetuximab is reported.
Time frame: Pre-dose (PRE) on Day 1 of Weeks 1, 5, 9, and 13 and post-dose (POST) on Day 1 of Weeks 1, 5, and 13
Population: PK evaluable population: Participants who received at least 1 dose of durvalumab and/or monalizumab and had at least 1 post-treatment sample available. Number of participants analyzed (N) denotes those participants who had adequate PK sample for analysis and number analyzed (n) denotes those participants who were analyzed for specified timepoint. Data is combined in a single arm with a respectable sample size as values from different cohorts with small cohort size will increase variability.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Serum Concentration of Cetuximab | Week 1 Day 1 (PRE) | 0.025 µg/mL | Standard Deviation 0 |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Serum Concentration of Cetuximab | Week 1 Day 1 (POST) | 400 µg/mL | Standard Deviation 138 |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Serum Concentration of Cetuximab | Week 5 Day 1 (PRE) | 73.6 µg/mL | Standard Deviation 108 |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Serum Concentration of Cetuximab | Week 5 Day 1 (POST) | 344 µg/mL | Standard Deviation 161 |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Serum Concentration of Cetuximab | Week 9 Day 1 (PRE) | 97.7 µg/mL | Standard Deviation 137 |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Serum Concentration of Cetuximab | Week 13 Day 1 (PRE) | 61.7 µg/mL | Standard Deviation 113 |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Serum Concentration of Cetuximab | Week 13 Day 1 (POST) | 387 µg/mL | Standard Deviation 101 |
Secondary
Serum Concentration of Durvalumab
Serum concentration of durvalumab is reported.
Time frame: Pre-dose (PRE) on Day 1 of Weeks 1, 5, 9, 13, and 25 and post-dose (POST) on Day 1 of Weeks 1 and 13
Population: PK evaluable population: Participants who received at least 1 dose of durvalumab and/or monalizumab and had at least 1 post-treatment sample available. Number of participants analyzed (N) denotes those participants who had adequate PK sample for analysis and number analyzed (n) denotes those participants who were analyzed for specified timepoint. Data is combined in a single arm with a respectable sample size as values from different cohorts with small cohort size will increase variability.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Serum Concentration of Durvalumab | Week 1 Day 1 (PRE) | 0.100 µg/mL | Standard Deviation 0.63 |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Serum Concentration of Durvalumab | Week 1 Day 1 (POST) | 399 µg/mL | Standard Deviation 157 |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Serum Concentration of Durvalumab | Week 5 Day 1 (PRE) | 90.8 µg/mL | Standard Deviation 95 |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Serum Concentration of Durvalumab | Week 9 Day 1 (PRE) | 127 µg/mL | Standard Deviation 148 |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Serum Concentration of Durvalumab | Week 13 Day 1 (PRE) | 142 µg/mL | Standard Deviation 123 |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Serum Concentration of Durvalumab | Week 13 Day 1 (POST) | 497 µg/mL | Standard Deviation 277 |
| Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Serum Concentration of Durvalumab | Week 25 Day 1 (PRE) | 149 µg/mL | Standard Deviation 109 |