Description:
This is a Phase 1/1b, multicenter, open-label, dose-escalation, and dose-expansion study to
evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical
activity of AB308 in combination with zimberelimab (AB122) in participants with advanced
malignancies.
Title
- Brief Title: A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies
- Official Title: A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB308 in Combination With AB122 in Participants With Advanced Malignancies
Clinical Trial IDs
- ORG STUDY ID:
ARC-12
- NCT ID:
NCT04772989
Conditions
- Advanced Solid Tumor
- NSCLC
- Melanoma
- Cervical Cancer
- Multiple Myeloma
- Lymphoma, Non-Hodgkin
- DLBCL
- Gastric Cancer
- Gastroesophageal Junction Adenocarcinoma
- Esophageal Cancer
Interventions
Drug | Synonyms | Arms |
---|
AB308 | | Dose Escalation Q3W Cohorts |
Zimberelimab | AB122 | Dose Escalation Q3W Cohorts |
Purpose
This is a Phase 1/1b, multicenter, open-label, dose-escalation, and dose-expansion study to
evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical
activity of AB308 in combination with zimberelimab (AB122) in participants with advanced
malignancies.
Trial Arms
Name | Type | Description | Interventions |
---|
Dose Escalation Q3W Cohorts | Experimental | Escalating doses of AB308 in combination with zimberelimab (360 mg) will be given every 3 weeks in participants with advanced malignancies. | |
Dose Escalation Q4W Cohorts | Experimental | Escalating doses of AB308 in combination with zimberelimab (480 mg) will be given every 4 weeks in participants with advanced malignancies. | |
Dose Expansion Cohort 1 | Experimental | AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with in participants with locally advanced or metastatic NSCLC. | |
Dose Expansion Cohort 2 | Experimental | AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with melanoma. | |
Dose Expansion Cohort 3 | Experimental | AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with metastatic gastric, or gastroesophageal junction, or esophageal cancer. | |
Dose Expansion Cohort 4 | Experimental | AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with cervical cancer. | |
Dose Expansion Cohort 5 | Experimental | AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with hematological malignancies. | |
Eligibility Criteria
- Performance status score of 0 or 1
- Measurable disease as per radiographic evaluation
- Disease-specific criteria for dose escalation:
- Participants with any type of solid tumor for which no treatment is currently
available, or
- Participants with non-Hodgkin Lymphoma that has progressed on prior chemotherapy
and have not or are unable to receive stem cell transplant. transfer
- Participants may have received up to 5 prior anti-cancer therapies and an
unlimited number of prior hormonal therapies.
- Disease-specific criteria for dose-expansion Cohort 1:
- Participants with previously untreated locally advanced or metastatic NSCLC with
a high PD-L1 expression
- Disease-specific criteria for dose-expansion Cohort 2:
- Participants with metastatic melanoma with at least one prior anti-cancer therapy
and progression after PD-L1 therapy
- Disease-specific criteria for dose-expansion Cohort 3:
- Participants with metastatic gastric, or gastroesophageal junction, or esophageal
cancer with at least 1 prior chemotherapy and no prior PD-(L)1 therapy.
- Disease-specific criteria for dose-expansion Cohort 4:
- Participants with metastatic cervical cancer with at least 1 prior chemotherapy
and no prior PD-(L)1 therapy.
- Disease-specific criteria for dose-expansion Cohort 5
- Participants with diffuse large B-cell lymphoma (DLBCL) with at least 2 prior
anti-cancer therapies and have not or are unable to receive allogenic stem cell
transplant
- Participants with multiple myeloma with at least 3 prior anti-cancer therapies
and for whom no treatment is currently available.
Exclusion Criteria:
- History of trauma or major surgery within 28 days prior to the first dose of study
treatment.
- Prior treatment with an anti-TIGIT antibody.
- Any active or prior autoimmune disease that required treatment within 3 years of the
first dose of study treatment.
- Prior chemotherapy, targeted small-molecule therapy, immunotherapy, or biologic
agents, or use of other investigational drugs within 28 days before first dose of
study treatment.
- Discontinued prior immunotherapy for immune related adverse events with a high
severity.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Percentage of participants with Adverse Events |
Time Frame: | From first study treatment administration until up to 90 days after the last dose (Approximately 1 year) |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Serum concentration of AB308 |
Time Frame: | Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days) )and up to the first 16 cycles of treatment (up to 15 months), and 30 and 90 days post last dose (i.e. in total up to approximately 18 months). |
Safety Issue: | |
Description: | |
Measure: | Serum concentration of zimberelimab |
Time Frame: | Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days) and up to the first 16 cycles of treatment (up to 15 months), and 30 and 90 days post last dose (i.e. in total up to approximately 18 months). |
Safety Issue: | |
Description: | |
Measure: | Percentage of participants with anti-drug antibodies to AB308 |
Time Frame: | Recorded at baseline (day 1 of cycle 1), during each of the first 4 cycles (each cycle is 21 days or 28 days) and up to the first 16 cycles of treatment (up to 15 months), and 30 and 90 days post last dose (i.e. in total up to approximately 18 months). |
Safety Issue: | |
Description: | |
Measure: | Percentage of participants with anti-drug antibodies to zimberelimab |
Time Frame: | Recorded at baseline (day 1 of cycle 1), during each of the first 4 cycles (each cycle is 21 days or 28 days) and up to the first 16 cycles of treatment (up to 15 months), and 30 and 90 days post last dose (i.e. in total up to approximately 18 months). |
Safety Issue: | |
Description: | |
Measure: | Percentage of participants with Objective Response |
Time Frame: | From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 3-5 years) |
Safety Issue: | |
Description: | |
Measure: | Duration of Response |
Time Frame: | From the date of first occurrence of a documented objective response to first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years) |
Safety Issue: | |
Description: | |
Measure: | Percentage of Participants with Disease Control (complete response, partial response, or stable disease) for >6 months |
Time Frame: | From study enrollment until disease progression or loss of clinical benefit (up to approximately 3-5 years) |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Arcus Biosciences, Inc. |
Last Updated
July 20, 2021