A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Dose Escalation Q3W Cohorts Escalating doses of AB308 in combination with zimberelimab (360 mg) will be given every 3 weeks in participants with advanced malignancies. |
Drug: AB308
Administered intravenously (IV) as specified in the treatment arm
Drug: Zimberelimab
Administered IV as specified in the treatment arm
Other Names:
|
Experimental: Dose Escalation Q4W Cohorts Escalating doses of AB308 in combination with zimberelimab (480 mg) will be given every 4 weeks in participants with advanced malignancies. |
Drug: AB308
Administered intravenously (IV) as specified in the treatment arm
Drug: Zimberelimab
Administered IV as specified in the treatment arm
Other Names:
|
Experimental: Dose Escalation Q6W Cohort Selected dose of AB308 in combination with zimberelimab will be given every 6 weeks in participants with advanced malignancies. |
Drug: AB308
Administered intravenously (IV) as specified in the treatment arm
Drug: Zimberelimab
Administered IV as specified in the treatment arm
Other Names:
|
Experimental: Dose Expansion Cohort 1 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. |
Drug: AB308
Administered intravenously (IV) as specified in the treatment arm
Drug: Zimberelimab
Administered IV as specified in the treatment arm
Other Names:
|
Experimental: Dose Expansion Cohort 2 AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with melanoma. |
Drug: AB308
Administered intravenously (IV) as specified in the treatment arm
Drug: Zimberelimab
Administered IV as specified in the treatment arm
Other Names:
|
Experimental: Dose Expansion Cohort 3 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. |
Drug: AB308
Administered intravenously (IV) as specified in the treatment arm
Drug: Zimberelimab
Administered IV as specified in the treatment arm
Other Names:
|
Experimental: Dose Expansion Cohort 4 AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with cervical cancer. |
Drug: AB308
Administered intravenously (IV) as specified in the treatment arm
Drug: Zimberelimab
Administered IV as specified in the treatment arm
Other Names:
|
Experimental: Dose Expansion Cohort 5 AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with hematological malignancies. |
Drug: AB308
Administered intravenously (IV) as specified in the treatment arm
Drug: Zimberelimab
Administered IV as specified in the treatment arm
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of participants with Adverse Events [From first study treatment administration until up to 90 days after the last dose (Approximately 1 year)]
- Percentage of participants who experience a Dose Limiting Toxicity [From first study treatment administration through Day 21 (Q3W arm) or Day 28 (Q4W arm) or Day 42 (Q6W arm)]
Secondary Outcome Measures
- Serum concentration of AB308 [Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)]
- Serum concentration of zimberelimab [Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)]
- Percentage of participants with anti-drug antibodies to AB308 [Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)]
- Percentage of participants with anti-drug antibodies to zimberelimab [Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)]
- Percentage of participants with Objective Response [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)]
- Duration of Response [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)]
- Percentage of Participants with Disease Control (complete response, partial response, or stable disease) for >6 months [From study enrollment until disease progression or loss of clinical benefit (up to approximately 3-5 years)]
Eligibility Criteria
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.
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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, gastroesophageal junction, or esophageal cancer with at least 1 prior chemotherapy and no prior PD-L1 therapy.
-
Disease-specific criteria for dose-expansion Cohort 4:
-
Participants with recurrent or metastatic cervical cancer with at least 1 prior chemotherapy and no prior PD-L1 therapy.
-
Disease-specific criteria for dose-expansion Cohort 5
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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.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Investigator Site | Phoenix | Arizona | United States | 85054-4502 |
2 | University of California, Los Angeles | Los Angeles | California | United States | 90095 |
3 | Investigator Site | Aurora | Colorado | United States | 80045-2545 |
4 | Investigator Sites | Jacksonville | Florida | United States | 32224 |
5 | Investigator Sites | Orlando | Florida | United States | 43210 |
6 | Investigator Site | Augusta | Georgia | United States | 30909-6520 |
7 | Goshen Health System #1 | Goshen | Indiana | United States | 46526 |
8 | Goshen Health System #2 | Goshen | Indiana | United States | 46526 |
9 | Investigator Site | Iowa City | Iowa | United States | 52242-1009 |
10 | Investigator Site | Louisville | Kentucky | United States | 40202-3700 |
11 | Henry Ford Health System | Novi | Michigan | United States | 48377 |
12 | Investigator Site | Rochester | Minnesota | United States | 55905 |
13 | Investigator Site | New York | New York | United States | 10032-3729 |
14 | Ohio State University | Columbus | Ohio | United States | 43210 |
15 | University of Oklahoma Peggy and Charles Stephenson Cancer Center | Oklahoma City | Oklahoma | United States | 73104 |
16 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15240 |
17 | Tennessee Onocology - Nashville | Nashville | Tennessee | United States | 37205 |
18 | START South Texas Accelerated Research Therapeutics - San Antonio | San Antonio | Texas | United States | 78229 |
19 | START South Texas Accelerated Research Therapeutics - Mountain Region | West Valley City | Utah | United States | 84119 |
20 | Virginia Cancer Specialists | Fairfax | Virginia | United States | 22033-1712 |
21 | University of Wisconsin - Madison | Madison | Wisconsin | United States | 53792 |
Sponsors and Collaborators
- Arcus Biosciences, Inc.
Investigators
- Study Director: Medical Director, Arcus Biosciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ARC-12
- 2021-005589-16