Advanced Solid Tumor
Conditions
Brief summary
A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202 in Patients with Advanced Solid Tumors
Detailed description
This is a first-in-human, Phase 1/2, multicenter, open-label study designed to evaluate the safety, tolerability, and efficacy of XTX202, an engineered IL-2 prodrug with its activity masked, as monotherapy in patients with advanced solid tumors. Phase 1 Part 1a will examine XTX202 monotherapy in an accelerated and standard 3+3 dose-escalation design. Based on the results of Part 1a, Part 1b will be initiated to further examine XTX202 in patients with select advanced solid tumors and to further characterize XTX202. Based on results of Phase 1 patients with select advanced solid tumors will be enrolled in Phase 2.
Interventions
DRUGXTX202
XTX202 Monotherapy
Sponsors
Xilio Development, Inc.
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
1. Disease Criteria * Phase 1, Part 1a: Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, or standard therapy is not curative or available * Phase 1, Part 1b: Histologically or cytologically confirmed solid tumor malignancy with one of the following tumor histologies: RCC of clear cell histology only, melanoma, squamous cell skin carcinoma, ovarian cancer, non-small cell lung cancer. Those patients who previously received immunotherapy must have derived benefit from this treatment. Additionally, patients with any of the above histologies in an advanced setting who plan to undergo debulking surgery or oligometastasectomy may be eligible to receive 2 cycles of XTX202 treatment in a "window of opportunity" subcohort". * Phase 2, Part 2a: Patients with metastatic RCC who have previously been treated with an anti-PD-1 and a TKI, per local and institutional SOC. Patients must have progressed on treatment with an anti-PD-1 mAb administered either as monotherapy or in combination with other therapies * Phase 2, Part 2b: Patients with unresectable or metastatic melanoma who have previously been treated with at least 1 prior line of therapy in the recurrent or metastatic setting. Prior therapy must have included an anti-PD-1 alone or in combination per local and institutional standard of care, and patient must have progressed on checkpoint inhibitor therapy. Patients with BRAF V600-activating mutation must have previously received targeted therapy per local and institutional standard of care. 2. ECOG performance status of 0 or 1 3. Adequate organ function 4. Part 1b only patients must be willing to provide fresh tumor biopsies before and after initiation of study treatment.
Exclusion criteria
1. Received prior treatment with IL-2 therapy 2. History of clinically significant pulmonary disease 3. History of clinically significant cardiovascular disease 4. Has a diagnosis of immunodeficiency 5. Has an active autoimmune disease that has required systemic treatment in past 2 years, including the use of disease modifying agents, corticosteroids or immunosuppressive drugs 6. Has an active infection requiring systemic therapy within 4 weeks prior to study treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Dose Limiting Toxicities (DLTs) (Phase 1 Part 1A Only) | Cycle 1 day 1 up to just prior to the second dose of study drug at Cycle 2 day 1 (each cycle is 21 days) | All participants in Phase 1 Part 1A (Dose Escalation) who received at least 1 dose of XTX202 and experienced a DLT. DLTs were defined as the following: * Any treatment-related Grade ≥ 3 toxicity * Any Grade febrile neutropenia * The following nonhematologic exceptions: * Grade 3 nausea or vomiting lasting \< 3 days * Grade 3 fatigue lasting \< 7 days * Any treatment-related toxicity that resulted in a treatment delay of ≥ 7 days |
| Incidence of Treatment-emergent Adverse Events (Phase 1 Only) | Up to 24 months | Treatment-emergent adverse event (TEAE) is defined as any adverse event that starts or increases in severity on or after the first dose of study drug and no later than 90 days after the last dose of study drug. Adverse events are graded using the NCI CTCAE version 5.0. |
| Investigator-assessed Objective Response Rate (ORR) Per RECIST 1.1 (Phase 2 Only) | Up to 24 months | Percentage of participants who achieved at least one confirmed Complete Response (CR) or Partial Response (PR). Response is based on Investigator assessment according to RECIST v1.1. In the analysis set used for ORR, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. |
| Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Biochemistry | Up to 24 months | Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a \>= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade. |
| Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Hematology | up to 24 months | Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a \>= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade. |
| Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Thyroid Function | Up to 24 months | Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value. |
| Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Coagulation | Up to 24 months | Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value. Missing = number of patients with missing baseline and/or post baseline laboratory value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator-assessed Objective Response Rate (ORR) Per RECIST 1.1 (Phase 1 Only) | Up to 24 months | Percentage of participants who achieved at least one confirmed Complete Response (CR) or Partial Response (PR). Response will be based on Investigator's assessment according to RECIST v1.1. |
| Duration of Response (DOR) (Phase 2 Only) | Up to 24 months | Duration of response is defined as time from first documentation of a subsequently confirmed objective response (CR or PR) to the date of the first documentation of radiographic disease progression according to Investigator assessment by RECIST v1.1, or death due to any cause, whichever occurs first. Participants who do not have an observed documented disease progression or death from any cause will be censored at the latest tumor response assessment date. |
| Disease Control Rate (Phase 2 Only) | Up to 24 months | Disease Control Rate (DCR) is defined as percentage of participants with confirmed BOR of CR, PR or SD (minimum duration of 6 weeks) according to RECIST v1.1, after the first dose of study treatment. In the analysis set used for DCR, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. |
| Overall Survival (OS) (Phase 2 Only) | Up to 24 months | OS is defined as the time from first administration of study treatment to death due to any cause. For participants without a record of death, OS will be censored at the date they were last known alive. In the analysis set used for OS, participants are assigned to a treatment group based on the initial dose received.. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group |
| Progression-free Survival (PFS) (Phase 2 Only) | Up to 24 months | PFS is defined as the time from first administration of study treatment until first documentation of radiographic PD according to RECIST v1.1, or death due to any cause, whichever occurs first. Participants who do not have an observed documented disease progression or death from any cause will be censored at the latest tumor response assessment date. In the analysis set used for PFS, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group |
| Incidence of Treatment-emergent Adverse Events (Phase 2 Only) | Up to 24 months | Treatment-emergent adverse event is defined as any adverse event (AE) that starts or increases in severity on or after the first dose of study drug and no later than 90 days after the last dose of study drug. AEs are graded using the NCI CTCAE version 5.0. |
| Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Hematology | Up to 24 months | Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a \>= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade. |
| Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Biochemistry | Up to 24 months | Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a \>= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade. |
| Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Thyroid Function | Up to 24 months | Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value. |
| Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Coagulation | Up to 24 months | Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value. |
| Plasma Concentrations of Total XTX202 | 0.00, 0.0167, 0.250, 0.500, 1.50, 3.00, 24.0, 72.0, 144, 312, 504 hours post-dose following a single administration of XTX202 on Cycle 1 | Plasma Concentration of Total XTX202 by Nominal Time (h) From End of Infusion Following a Single IV Administration of XTX202. In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. |
| Plasma Concentrations of Intact XTX202 | 0.00, 0.0167, 0.250, 0.500, 1.50, 3.00, 24.0, 72.0, 144, 312, 504 hours post-dose following a single administration of XTX202 on Cycle 1 | Plasma Concentration of Intact XTX202 by Nominal Time (h) From End of Infusion Following a Single IV Administration of XTX202. In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. |
| Total XTX202 Plasma Trough Concentration | From Cycle 1 to up to Cycle 18 (21 days per cycle) | Plasma Trough Concentration of Total XTX202 Following Multiple IV Administrations of XTX202. In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group |
| Intact XTX202 Plasma Trough Concentration | from Cycle 1 to up to Cycle 18 (21 days per cycle) | Plasma Trough Concentration of Intact XTX202 Following Multiple IV Administrations of XTX202. In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. |
| Maximum Observed Plasma Concentration (Cmax) of Total XTX202 | up to 21 days following a single IV infusion of XTX202 on Cycle 1 | Cmax following a single IV infusion of XTX202. In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. |
| Maximum Observed Plasma Concentration (Cmax) of Intact XTX202 | up to 21 days following a single IV infusion of XTX202 on Cycle 1 | Cmax following a single IV infusion of XTX202. In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. |
| Time of Maximum Observed Concentration (Tmax) of Total XTX202 | up to 21 days following a single IV infusion of XTX202 on Cycle 1 | Time of maximum observed concentration (Tmax) of total XTX202 following a single IV infusion of XTX202. In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. |
| Time of Maximum Observed Concentration (Tmax) of Intact XTX202 | up to 21 days following a single IV infusion of XTX202 on Cycle 1 | Time of maximum observed concentration (Tmax) of intact XTX202 following a single IV infusion of XTX202. In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. |
| Area Under the Curve From Time 0 to 504 Hours (AUC0-504) of Total XTX202 | up to 21 days following a single IV infusion of XTX202 on Cycle 1 | Area under the curve (AUC)of total XTX202 following a single IV infusion of XTX202. In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. |
| Area Under the Curve From Time 0 to 504 Hours (AUC0-504) of Intact XTX202 | up to 21 days following a single IV infusion of XTX202 on Cycle 1 | Area under the curve (AUC) of intact XTX202 following a single IV infusion of XTX202. In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. |
| Half-life (T1/2) of Total XTX202 | up to 21 days following a single IV infusion of XTX202 on Cycle 1 | Half-life (T1/2) of total XTX202 following a single IV infusion of XTX202. In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. |
| Half-life (T1/2) of Intact XTX202 | up to 21 days following a single IV infusion of XTX202 on Cycle 1 | Half-life (T1/2) of intact XTX202 following a single IV infusion of XTX202. In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. |
| Systemic Clearance (CL) of Total XTX202 | up to 21 days following a single IV infusion of XTX202 on Cycle 1 | Systemic clearance (CL) of Total XTX202 following a single IV infusion of XTX202. In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. |
| Systemic Clearance (CL) of Intact XTX202 | up to 21 days following a single IV infusion of XTX202 on Cycle 1 | Systemic clearance (CL) of intact XTX202 following a single IV infusion of XTX202. In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. |
| Volume of Distribution (Vd) of Total XTX202 | up to 21 days following a single IV infusion of XTX202 on Cycle 1 | Volume of distribution (Vd) of total XTX202 following a single IV infusion of XTX202. In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. |
| Volume of Distribution (Vd) of Intact XTX202 | up to 21 days following a single IV infusion of XTX202 on Cycle 1 | Volume of distribution (Vd) of intact XTX202 following a single IV infusion of XTX202. In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. |
| Antidrug Antibody (ADA) Occurrence and Titer in Serum (Phase 1 Only) | from Cycle 1 Day 1 to up to 24 months | Overall ADA Incidence Following a Single IV Administration of XTX202 In the analysis set used for ADA, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. |
| Incidence and Persistence of ADAs (Including Neutralizing ADAs) and Titers (Phase 2 Only) | From Cycle 1 Day 1 to up to 24 months | Overall ADA Incidence Following a Single IV Administration of XTX202. In the analysis set used for ADA, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. |
Countries
United States
Participant flow
Pre-assignment details
In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 63.5 years STANDARD_DEVIATION 11.91 |
| Age, Customized ≥ 60 to <75 | 4 Participants |
| Age, Customized <65 | 45 Participants |
| Age, Customized ≥ 75 | 15 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants |
| Race/Ethnicity, Customized White | 3 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 3 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 / 1 | 2 / 3 | 3 / 3 | 6 / 8 | 11 / 13 | 6 / 8 | 5 / 13 | 0 / 1 | 2 / 2 | 2 / 5 | 0 / 1 | 0 / 2 | 0 / 15 | 1 / 5 | 6 / 15 |
| other Total, other adverse events | 1 / 1 | 1 / 3 | 2 / 3 | 6 / 8 | 10 / 13 | 7 / 8 | 12 / 13 | 0 / 1 | 2 / 2 | 3 / 5 | 1 / 1 | 2 / 2 | 15 / 15 | 5 / 5 | 14 / 15 |
| serious Total, serious adverse events | 0 / 1 | 0 / 3 | 0 / 3 | 0 / 8 | 0 / 13 | 0 / 8 | 4 / 13 | 0 / 1 | 0 / 2 | 0 / 5 | 0 / 1 | 0 / 2 | 6 / 15 | 2 / 5 | 2 / 15 |
Outcome results
None listed