Trials / Completed
CompletedNCT03629756
A Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Advanced Malignancies
A Phase 1 Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Advanced Malignancies
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Arcus Biosciences, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
In the dose-escalation phase, escalating doses of etrumadenant in combination with zimberelimab will be assessed in participants with advanced malignancies. Eligible participants will receive oral administration of etrumadenant as well as IV infusion of zimberelimab. The recommended Phase 2 dose (RP2D) of etrumadenant will be determined upon completion of the dose-escalation phase. In the dose-expansion phase, etrumadenant at RP2D in combination with zimberelimab may be assessed in participants with advanced clear-cell renal cell carcinoma (RCC) or metastatic castrate-resistant adenocarcinoma of the prostate (mCRPC). Overall duration of treatment will depend on how well the treatment is tolerated. Treatment may continue until unacceptable toxicity or progressive disease or other reasons specified in the protocol.
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
| Type | Name | Description |
|---|---|---|
| DRUG | Etrumadenant | Etrumadenant is an A2aR and A2bR antagonist. |
| DRUG | Zimberelimab | Zimberelimab is a fully human anti-PD-1 monoclonal antibody. |
Timeline
- Start date
- 2018-07-24
- Primary completion
- 2021-08-18
- Completion
- 2021-09-03
- First posted
- 2018-08-14
- Last updated
- 2024-05-24
Locations
15 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03629756. Inclusion in this directory is not an endorsement.