Solid Tumor
Conditions
Brief summary
The goals of this clinical study are to learn about the safety, tolerability, dosing and effectiveness of magrolimab in combination with docetaxel in participants with solid tumors.
Detailed description
This study will consist of a Safety Run-in Cohort 1 (magrolimab + docetaxel combination). After completion of the Safety Run-in Cohort 1, Phase 2 Cohort 1 will occur as follows: * Phase 2 Cohort 1: a cohort of participants with solid tumors (metastatic non-small cell lung cancer (mNSCLC) (Phase 2 Cohort 1a), metastatic urothelial cancer (mUC) (Phase 2 Cohort 1b), and metastatic small cell lung cancer (mSCLC) (Phase 2 Cohort 1c).
Interventions
DRUGMagrolimab
Administered intravenously
DRUGDocetaxel
Administered intravenously
Sponsors
Gilead Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Individual must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. * Adequate blood counts. * Adequate renal function. * Adequate liver function. * Pretreatment blood cross-match completed. * Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. * Measurable disease according to response evaluation criteria in solid tumours (RECIST) version 1.1 Cohort-Specific Inclusion Criteria: * Safety Run-in Cohort 1: Individuals with metastatic advanced solid tumors who have had at least 1 prior line of systemic anticancer therapy (metastatic non-small cell lung cancer (mNSCLC) and metastatic small cell lung cancer (mSCLC)) in a locally advanced/metastatic setting, or 2 prior lines of systemic anticancer therapy (metastatic urothelial cancer (mUC)) in a locally advanced/metastatic setting, and not more than 3 prior lines of systemic anticancer therapy in a locally advanced/metastatic setting. * Phase 2 Cohort 1a (mNSCLC): Individuals with NSCLC who have had treatment with platinum-based chemotherapy and immune checkpoint inhibitor therapy in a locally advanced/metastatic setting, either in combination or sequentially (unless not eligible for one of these therapies) are eligible. At least 1 prior line of systemic anticancer therapy in a locally advanced/metastatic setting is required and not more than 2 prior lines of systemic anticancer therapy in a locally advanced/metastatic setting are allowed. Individuals treated with a taxane within 12 months or individuals refractory to prior taxane treatment are excluded. Individuals whose tumors have genomic alterations are excluded. * Phase 2 Cohort 1b (mUC): Individuals with UC who have had prior treatment with systemic chemotherapy and immune checkpoint inhibitor therapy in a locally advanced/metastatic setting (unless not eligible for one of these therapies) are eligible. At least 2 prior lines of systemic anticancer therapy in a locally advanced/metastatic setting are required and not more than 3 prior lines of systemic anticancer therapy in a locally advanced/metastatic setting are allowed. Individuals treated with a taxane within 12 months or individuals refractory to prior taxane treatment are excluded. * Phase 2 Cohort 1c (mSCLC): Individuals with SCLC who have had prior treatment with platinum-based chemotherapy and/or immune checkpoint inhibitor therapy are eligible. At least 1 prior line of systemic anticancer therapy in a locally advanced/metastatic setting is required and not more than 2 prior lines of systemic anticancer therapy in a locally advanced/metastatic setting are allowed. Individuals treated with a taxane within 12 months or individuals refractory to prior taxane treatment are excluded. Note: Maintenance therapies are not counted as separate lines of therapy. Key
Exclusion criteria
* Positive serum pregnancy test. * Breastfeeding female. * Active central nervous system (CNS) disease. Individuals with asymptomatic and stable, treated CNS lesions (radiation and/or surgery and/or other CNS-directed therapy who have not received corticosteroids for at least 4 weeks) are allowed. * Red blood cell (RBC) transfusion dependence, defined as requiring more than 2 units of packed red blood cell transfusions during the 4-week period prior to screening. RBC transfusions are permitted during the screening period and prior to enrollment to meet the hemoglobin inclusion criteria. * History of hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 3 months. * Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient. * Prior treatment with cluster of differentiation (CD)47 or signal regulatory protein alpha-targeting agents. * Current participation in another interventional clinical study. * Known inherited or acquired bleeding disorders. * Significant disease or medical conditions, as assessed by the investigator and sponsor, that would substantially increase the risk-benefit ratio of participating in the study. This includes, but is not limited to, acute myocardial infarction within the last 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, and congestive heart failure New York Heart Association Class III-IV. * Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which individuals are not on active anticancer therapies and who are in complete remission for over 3 years. * Known active or chronic hepatitis B or C infection or human immunodeficiency virus. * Prior anticancer therapy including but not limited to chemotherapy, immunotherapy, or investigational agents within 4 weeks prior to magrolimab is not permitted. * Note: Localized non-CNS radiotherapy, previous hormonal therapy with luteinizing hormone releasing hormone agonists for prostate or breast cancer, and treatment with bisphosphonates and receptor activator of nuclear factor kappa B ligand (RANKL) inhibitors are not criteria for exclusion. Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | First dose date up to 113 weeks plus 30 days | TEAEs were defined as any adverse events (AE) not present prior to the study treatment, or any events already present but worsening in either intensity or frequency following exposure to the study treatment. The TEAE reporting period is defined as the period from the date of the first dose of study treatment up to 30 days after the date of the last dose of study treatment or the day before initiation of subsequent antineoplastic therapy, whichever comes first. An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. |
| Percentage of Participants With Treatment-Emergent Laboratory Abnormalities | First dose date up to 113 weeks plus 30 days | Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days and prior to the day of initiation of subsequent anti-cancer therapy. Percentages were rounded off. |
| Objective Response Rate (ORR) (Phase 2 Cohorts 1a, 1b, and 1c) | Up to 90 Weeks | ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR), as measured by RECIST version 1.1, as determined by investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Clopper-Pearson method was used in outcome measure analysis. Percentages were rounded-off. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Concentration of Magrolimab | Day 1, Day 8 Predose, Day 8 1-Hour Postdose, Day 22, Day 43 Predose, Day 43 1-Hour Postdose, Day 85, Day 127, Day 190 and Day 253 Predose | — |
| Progression-free Survival (PFS) (Phase 2 Cohorts 1a, 1b, and 1c) | Up to 117 Weeks | PFS was defined as the interval from the first dosing date of any study drug to the earlier date of the first documentation of objective disease progression (PD) by investigator assessment per RECIST, Version 1.1, or death from any cause. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions was also considered progression). Kaplan-Meier (KM) estimates were used in outcome measure analysis. |
| Percentage of Participants Who Developed Anti-Magrolimab Antibodies | Up to 113 Weeks | — |
| Duration of Response (DOR) (Phase 2 Cohorts 1a, 1b, and 1c) | Up to 117 Weeks | DOR was defined as time from first documentation of CR or PR to the earliest date of documented PD, per RECIST, Version 1.1, or death from any cause, whichever occurs first, as determined by investigator assessment. CR and PR are defined in outcome measure #3 and PD is defined in outcome measure #4. KM Estimates were used in outcome measure analysis. |
| Overall Survival (OS) (Phase 2 Cohorts 1a, 1b, and 1c) | Up to 117 Weeks | OS is defined as time from date of dose initiation to death from any cause. KM estimates were used in outcome measure analysis. |
Countries
France, Poland, Spain, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in Spain, Poland, France, United States, and the United Kingdom.
Pre-assignment details
159 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| Safety Run-in Cohort 1 (Magrolimab + Docetaxel) Participants with solid tumors (including metastatic non small cell lung cancer (mNSCLC), metastatic urothelial cancer (mUC), and metastatic small cell lung cancer (mSCLC)) received 1 mg/kg magrolimab intravenously (IV) on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 113 weeks; and 75 mg/m\^2 docetaxel IV on Day 1 of each cycle for up to 113 weeks; each cycle length = 21 days. | 9 |
| Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) Participants with mNSCLC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 90 weeks; and 75 mg/m\^2 docetaxel IV on Day 1 of each cycle for up to 69 weeks; each cycle length = 21 days. | 29 |
| Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) Participants with mUC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 68 weeks; and 75 mg/m\^2 docetaxel IV on Day 1 of each cycle for up to 68 weeks; each cycle length = 21 days. | 26 |
| Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) Participants with mSCLC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 72 weeks; and 75 mg/m\^2 docetaxel IV on Day 1 of each cycle for up to 72 weeks; each cycle length = 21 days. | 42 |
| Total~(N=106) | 106 |
| Total | 212 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 5 | 17 | 17 | 32 |
| Overall Study | Investigator's Discretion | 1 | 0 | 2 | 5 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 |
| Overall Study | Study Terminated by Sponsor | 2 | 9 | 7 | 5 |
| Overall Study | Withdrew Consent | 0 | 3 | 0 | 0 |
Baseline characteristics
| Characteristic | Safety Run-in Cohort 1 (Magrolimab + Docetaxel) | Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) | Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) | Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) | Total~(N=106) |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 16 Participants | 14 Participants | 15 Participants | 49 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 13 Participants | 12 Participants | 27 Participants | 57 Participants |
| Age, Continuous | 66 years STANDARD_DEVIATION 8.2 | 63 years STANDARD_DEVIATION 10.8 | 65 years STANDARD_DEVIATION 9.8 | 62 years STANDARD_DEVIATION 6.6 | 63 years STANDARD_DEVIATION 8.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 25 Participants | 20 Participants | 30 Participants | 83 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 6 Participants | 11 Participants | 19 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 6 Participants | 11 Participants | 18 Participants |
| Race (NIH/OMB) White | 7 Participants | 27 Participants | 19 Participants | 30 Participants | 83 Participants |
| Region of Enrollment France | 0 Participants | 1 Participants | 6 Participants | 11 Participants | 18 Participants |
| Region of Enrollment Poland | 0 Participants | 2 Participants | 0 Participants | 4 Participants | 6 Participants |
| Region of Enrollment Spain | 0 Participants | 17 Participants | 9 Participants | 14 Participants | 40 Participants |
| Region of Enrollment United Kingdom | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Region of Enrollment United States | 9 Participants | 9 Participants | 9 Participants | 12 Participants | 39 Participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 7 Participants | 17 Participants | 34 Participants |
| Sex: Female, Male Male | 5 Participants | 23 Participants | 19 Participants | 25 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 6 / 9 | 17 / 29 | 18 / 26 | 37 / 42 |
| other Total, other adverse events | 9 / 9 | 29 / 29 | 26 / 26 | 41 / 42 |
| serious Total, serious adverse events | 5 / 9 | 16 / 29 | 12 / 26 | 18 / 42 |
Outcome results
Primary
Objective Response Rate (ORR) (Phase 2 Cohorts 1a, 1b, and 1c)
ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR), as measured by RECIST version 1.1, as determined by investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Clopper-Pearson method was used in outcome measure analysis. Percentages were rounded-off.
Time frame: Up to 90 Weeks
Population: Participants in the modified intent to treat analysis set were analyzed. The study had 2 parts - Safety Run-in and Phase 2. Per pre-specified analysis, this endpoint was applicable only to Phase 2 cohorts. Therefore, data for cohorts of Phase 2 are reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Safety Run-in Cohort 1 (Magrolimab + Docetaxel) | Objective Response Rate (ORR) (Phase 2 Cohorts 1a, 1b, and 1c) | 17.2 percentage of participants |
| Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) | Objective Response Rate (ORR) (Phase 2 Cohorts 1a, 1b, and 1c) | 3.8 percentage of participants |
| Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) | Objective Response Rate (ORR) (Phase 2 Cohorts 1a, 1b, and 1c) | 4.8 percentage of participants |
Primary
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
TEAEs were defined as any adverse events (AE) not present prior to the study treatment, or any events already present but worsening in either intensity or frequency following exposure to the study treatment. The TEAE reporting period is defined as the period from the date of the first dose of study treatment up to 30 days after the date of the last dose of study treatment or the day before initiation of subsequent antineoplastic therapy, whichever comes first. An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution.
Time frame: First dose date up to 113 weeks plus 30 days
Population: Participants in the Safety Analysis Set were analyzed. The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Safety Run-in Cohort 1 (Magrolimab + Docetaxel) | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | 100.0 percentage of participants |
| Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | 100.0 percentage of participants |
| Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | 100.0 percentage of participants |
| Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | 100.0 percentage of participants |
Primary
Percentage of Participants With Treatment-Emergent Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days and prior to the day of initiation of subsequent anti-cancer therapy. Percentages were rounded off.
Time frame: First dose date up to 113 weeks plus 30 days
Population: Participants in the Safety Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Safety Run-in Cohort 1 (Magrolimab + Docetaxel) | Percentage of Participants With Treatment-Emergent Laboratory Abnormalities | Any Grade | 100 percentage of participants |
| Safety Run-in Cohort 1 (Magrolimab + Docetaxel) | Percentage of Participants With Treatment-Emergent Laboratory Abnormalities | Grade 3 or Higher | 77.8 percentage of participants |
| Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) | Percentage of Participants With Treatment-Emergent Laboratory Abnormalities | Grade 3 or Higher | 82.8 percentage of participants |
| Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) | Percentage of Participants With Treatment-Emergent Laboratory Abnormalities | Any Grade | 100 percentage of participants |
| Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) | Percentage of Participants With Treatment-Emergent Laboratory Abnormalities | Any Grade | 100 percentage of participants |
| Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) | Percentage of Participants With Treatment-Emergent Laboratory Abnormalities | Grade 3 or Higher | 92.3 percentage of participants |
| Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) | Percentage of Participants With Treatment-Emergent Laboratory Abnormalities | Any Grade | 100 percentage of participants |
| Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) | Percentage of Participants With Treatment-Emergent Laboratory Abnormalities | Grade 3 or Higher | 78.6 percentage of participants |
Secondary
Duration of Response (DOR) (Phase 2 Cohorts 1a, 1b, and 1c)
DOR was defined as time from first documentation of CR or PR to the earliest date of documented PD, per RECIST, Version 1.1, or death from any cause, whichever occurs first, as determined by investigator assessment. CR and PR are defined in outcome measure #3 and PD is defined in outcome measure #4. KM Estimates were used in outcome measure analysis.
Time frame: Up to 117 Weeks
Population: Participants in the modified Intent-to-Treat Analysis Set who achieved CR or PR were analyzed. The study had 2 parts - Safety Run-in and Phase 2. Per pre-specified analysis, this endpoint was applicable only to Phase 2 cohorts. Therefore, data for cohorts of Phase 2 are reported.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Safety Run-in Cohort 1 (Magrolimab + Docetaxel) | Duration of Response (DOR) (Phase 2 Cohorts 1a, 1b, and 1c) | 7.6 months |
| Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) | Duration of Response (DOR) (Phase 2 Cohorts 1a, 1b, and 1c) | NA months |
| Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) | Duration of Response (DOR) (Phase 2 Cohorts 1a, 1b, and 1c) | 4.7 months |
Secondary
Overall Survival (OS) (Phase 2 Cohorts 1a, 1b, and 1c)
OS is defined as time from date of dose initiation to death from any cause. KM estimates were used in outcome measure analysis.
Time frame: Up to 117 Weeks
Population: Participants in the modified Intent-to-Treat Analysis Set were analyzed. The study had 2 parts - Safety Run-in and Phase 2. Per pre-specified analysis, this endpoint was applicable only to Phase 2 cohorts. Therefore, data for cohorts of Phase 2 are reported.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Safety Run-in Cohort 1 (Magrolimab + Docetaxel) | Overall Survival (OS) (Phase 2 Cohorts 1a, 1b, and 1c) | 9.8 months |
| Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) | Overall Survival (OS) (Phase 2 Cohorts 1a, 1b, and 1c) | 7.6 months |
| Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) | Overall Survival (OS) (Phase 2 Cohorts 1a, 1b, and 1c) | 6.4 months |
Secondary
Percentage of Participants Who Developed Anti-Magrolimab Antibodies
Time frame: Up to 113 Weeks
Population: Participants in the Immunogenicity Analysis Set with available data were analyzed. The Immunogenicity Analysis Set includes all participants who received any amount of magrolimab and have at least 1 evaluable anti-magrolimab antibody test result.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Safety Run-in Cohort 1 (Magrolimab + Docetaxel) | Percentage of Participants Who Developed Anti-Magrolimab Antibodies | 0 percentage of participants |
| Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) | Percentage of Participants Who Developed Anti-Magrolimab Antibodies | 4.0 percentage of participants |
| Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) | Percentage of Participants Who Developed Anti-Magrolimab Antibodies | 8.0 percentage of participants |
| Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) | Percentage of Participants Who Developed Anti-Magrolimab Antibodies | 0 percentage of participants |
Secondary
Progression-free Survival (PFS) (Phase 2 Cohorts 1a, 1b, and 1c)
PFS was defined as the interval from the first dosing date of any study drug to the earlier date of the first documentation of objective disease progression (PD) by investigator assessment per RECIST, Version 1.1, or death from any cause. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions was also considered progression). Kaplan-Meier (KM) estimates were used in outcome measure analysis.
Time frame: Up to 117 Weeks
Population: Participants in the modified Intent-to-Treat Analysis Set were analyzed. The study had 2 parts - Safety Run-in and Phase 2. Per pre-specified analysis, this endpoint was applicable only to Phase 2 cohorts. Therefore, data for cohorts of Phase 2 are reported.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Safety Run-in Cohort 1 (Magrolimab + Docetaxel) | Progression-free Survival (PFS) (Phase 2 Cohorts 1a, 1b, and 1c) | 4.2 months |
| Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) | Progression-free Survival (PFS) (Phase 2 Cohorts 1a, 1b, and 1c) | 2.7 months |
| Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) | Progression-free Survival (PFS) (Phase 2 Cohorts 1a, 1b, and 1c) | 2.2 months |
Secondary
Serum Concentration of Magrolimab
Time frame: Day 1, Day 8 Predose, Day 8 1-Hour Postdose, Day 22, Day 43 Predose, Day 43 1-Hour Postdose, Day 85, Day 127, Day 190 and Day 253 Predose
Population: The participants in the Pharmacokinetic (PK) Analysis Set with available data were analyzed. The PK Analysis Set included all participants who received any amount of magrolimab and have at least 1 measurable posttreatment serum concentration of magrolimab. Here 'N' is defined as participants with available data at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Safety Run-in Cohort 1 (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 8 1-Hour Postdose | 407 μg/mL | — |
| Safety Run-in Cohort 1 (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 22 Predose | 460 μg/mL | Standard Deviation 112 |
| Safety Run-in Cohort 1 (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 253 Predose | 237 μg/mL | Standard Deviation 56.6 |
| Safety Run-in Cohort 1 (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 43 Predose | 624 μg/mL | Standard Deviation 451 |
| Safety Run-in Cohort 1 (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 190 Predose | 281 μg/mL | Standard Deviation 71.1 |
| Safety Run-in Cohort 1 (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 127 Predose | 277 μg/mL | Standard Deviation 35 |
| Safety Run-in Cohort 1 (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 8 Predose | 0 μg/mL | Standard Deviation 0 |
| Safety Run-in Cohort 1 (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 1 Predose | 0 μg/mL | Standard Deviation 0 |
| Safety Run-in Cohort 1 (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 85 Predose | 415 μg/mL | Standard Deviation 135 |
| Safety Run-in Cohort 1 (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 43 1- Hour Postdose | 1880 μg/mL | Standard Deviation 523 |
| Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 85 Predose | 266 μg/mL | Standard Deviation 134 |
| Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 1 Predose | 0 μg/mL | Standard Deviation 0 |
| Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 8 Predose | 0 μg/mL | Standard Deviation 0 |
| Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 22 Predose | 302 μg/mL | Standard Deviation 161 |
| Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 43 Predose | 523 μg/mL | Standard Deviation 195 |
| Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 43 1- Hour Postdose | 1550 μg/mL | Standard Deviation 525 |
| Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 127 Predose | 281 μg/mL | Standard Deviation 143 |
| Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 190 Predose | 344 μg/mL | Standard Deviation 104 |
| Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 253 Predose | 363 μg/mL | Standard Deviation 179 |
| Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 127 Predose | 393 μg/mL | Standard Deviation 93.8 |
| Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 43 1- Hour Postdose | 1560 μg/mL | Standard Deviation 492 |
| Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 85 Predose | 319 μg/mL | Standard Deviation 271 |
| Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 22 Predose | 260 μg/mL | Standard Deviation 148 |
| Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 1 Predose | 0 μg/mL | Standard Deviation 0 |
| Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 43 Predose | 439 μg/mL | Standard Deviation 182 |
| Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 8 Predose | 0 μg/mL | Standard Deviation 0 |
| Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 8 Predose | 0 μg/mL | Standard Deviation 0 |
| Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 43 Predose | 529 μg/mL | Standard Deviation 258 |
| Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 43 1- Hour Postdose | 1730 μg/mL | Standard Deviation 560 |
| Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 85 Predose | 297 μg/mL | Standard Deviation 181 |
| Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 1 Predose | 0 μg/mL | Standard Deviation 0 |
| Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 190 Predose | 250 μg/mL | Standard Deviation 113 |
| Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 127 Predose | 174 μg/mL | Standard Deviation 106 |
| Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) | Serum Concentration of Magrolimab | Day 22 Predose | 334 μg/mL | Standard Deviation 134 |