A Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Advanced Malignancies
NCT03629756 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2024-05-24
Summary
This is a Phase 1, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and clinical activity of etrumadenant (AB928) in combination with zimberelimab (AB122) (an anti-PD-1 antibody) in participants with advanced malignancies.
Conditions
- Non-small Cell Lung Cancer
- Squamous Cell Carcinoma of the Head and Neck
- Breast Cancer
- Colorectal Cancer
- Melanoma
- Bladder Cancer
- Ovarian Cancer
- Endometrial Cancer
- Merkel Cell Carcinoma
- GastroEsophageal Cancer
- Renal Cell Carcinoma
- Castration-resistant Prostate Cancer
Interventions
- DRUG
-
Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist.
- DRUG
-
Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody.
Sponsors & Collaborators
-
Arcus Biosciences, Inc.
lead INDUSTRY
Principal Investigators
-
Medical Director · Arcus Biosciences, Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-07-24
- Primary Completion
- 2021-08-18
- Completion
- 2021-09-03
- FDA Drug
- Yes
Countries
- United States
- Australia
Study Locations
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