A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies (ARC-12)

Arcus Biosciences

Status and phase: Active, not recruiting; Phase 1

Conditions: Multiple Myeloma; Melanoma; Esophageal Cancer; Gastric Cancer; Advanced Solid Tumor; Diffuse Large B Cell Lymphoma (DLBCL); Non Small Cell Lung Cancer (NSCLC); Lymphoma, Non-Hodgkin; Gastroesophageal Junction Adenocarcinoma; Cervical Cancer

Treatments: Drug: AB308; Drug: Zimberelimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04772989

ARC-12

2024-511116-25-00 (EU Trial (CTIS) Number)

2021-005589-16 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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94 participants in 8 patient groups

Dose Escalation Q3W Cohorts

Experimental group

Description:

Escalating doses of AB308 in combination with zimberelimab (360 mg) will be given every 3 weeks in participants with advanced malignancies.

Treatment:

Drug: Zimberelimab

Drug: AB308

Dose Escalation Q4W Cohorts

Experimental group

Description:

Escalating doses of AB308 in combination with zimberelimab (480 mg) will be given every 4 weeks in participants with advanced malignancies.

Treatment:

Drug: Zimberelimab

Drug: AB308

Dose Escalation Q6W Cohort

Experimental group

Description:

Selected dose of AB308 in combination with zimberelimab will be given every 6 weeks in participants with advanced malignancies.

Treatment:

Drug: Zimberelimab

Drug: AB308

Dose Expansion Cohort 1

Experimental group

Description:

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.

Treatment:

Drug: Zimberelimab

Drug: AB308

Dose Expansion Cohort 2

Experimental group

Description:

AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with melanoma.

Treatment:

Drug: Zimberelimab

Drug: AB308

Dose Expansion Cohort 3

Experimental group

Description:

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.

Treatment:

Drug: Zimberelimab

Drug: AB308

Dose Expansion Cohort 4

Experimental group

Description:

AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with cervical cancer.

Treatment:

Drug: Zimberelimab

Drug: AB308

Dose Expansion Cohort 5

Experimental group

Description:

AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with hematological malignancies.

Treatment:

Drug: Zimberelimab

Drug: AB308