A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies (ARC-12)
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| ClinicalTrials.gov Identifier: NCT04772989 |
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Recruitment Status :
Recruiting
First Posted : February 26, 2021
Last Update Posted : June 9, 2023
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Sponsor:
Arcus Biosciences, Inc.
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Arcus Biosciences, Inc.
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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 |
|---|---|---|
| Advanced Solid Tumor NSCLC Melanoma Cervical Cancer Multiple Myeloma Lymphoma, Non-Hodgkin DLBCL Gastric Cancer Gastroesophageal Junction Adenocarcinoma Esophageal Cancer | Drug: AB308 Drug: Zimberelimab | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 107 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB308 in Combination With AB122 in Participants With Advanced Malignancies |
| Actual Study Start Date : | March 19, 2021 |
| Estimated Primary Completion Date : | July 2025 |
| Estimated Study Completion Date : | July 2025 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: AB308
Administered intravenously (IV) as specified in the treatment arm Drug: Zimberelimab Administered IV as specified in the treatment arm
Other Name: AB122 |
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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.
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Drug: AB308
Administered intravenously (IV) as specified in the treatment arm Drug: Zimberelimab Administered IV as specified in the treatment arm
Other Name: AB122 |
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Experimental: Dose Escalation Q6W Cohort
Selected dose of AB308 in combination with zimberelimab will be given every 6 weeks in participants with advanced malignancies.
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Drug: AB308
Administered intravenously (IV) as specified in the treatment arm Drug: Zimberelimab Administered IV as specified in the treatment arm
Other Name: AB122 |
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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.
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Drug: AB308
Administered intravenously (IV) as specified in the treatment arm Drug: Zimberelimab Administered IV as specified in the treatment arm
Other Name: AB122 |
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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.
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Drug: AB308
Administered intravenously (IV) as specified in the treatment arm Drug: Zimberelimab Administered IV as specified in the treatment arm
Other Name: AB122 |
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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.
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Drug: AB308
Administered intravenously (IV) as specified in the treatment arm Drug: Zimberelimab Administered IV as specified in the treatment arm
Other Name: AB122 |
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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.
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Drug: AB308
Administered intravenously (IV) as specified in the treatment arm Drug: Zimberelimab Administered IV as specified in the treatment arm
Other Name: AB122 |
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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.
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Drug: AB308
Administered intravenously (IV) as specified in the treatment arm Drug: Zimberelimab Administered IV as specified in the treatment arm
Other Name: AB122 |
Primary Outcome Measures :
- 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) ]
- Percentage of participants who experience a Dose Limiting Toxicity [ Time Frame: 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 [ 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 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 [ 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 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 [ 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 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 [ 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 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 [ 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) ]
- 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) ]
- 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) ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Male or female participants ≥ 18 years of age (or age ≥ regionally approved age of consent for participation in investigational clinical studies) at the time of signing the informed consent.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Adequate organ and marrow function
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04772989
Contacts
| Contact: Medical Director | +1-510-462-3330 | ClinicalTrialInquiry@arcusbio.com |
Locations
Show 28 study locations
Sponsors and Collaborators
Arcus Biosciences, Inc.
Gilead Sciences
Investigators
| Study Director: | Medical Director | Arcus Biosciences |
| Responsible Party: | Arcus Biosciences, Inc. |
| ClinicalTrials.gov Identifier: | NCT04772989 |
| Other Study ID Numbers: |
ARC-12 2021-005589-16 ( EudraCT Number ) |
| First Posted: | February 26, 2021 Key Record Dates |
| Last Update Posted: | June 9, 2023 |
| Last Verified: | June 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website. |
| URL: | https://trials.arcusbio.com/our-transparency-policy |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Multiple Myeloma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias |
Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Lymphoma Lymphatic Diseases |