Spots Global Cancer Trial Database for A Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Advanced Malignancies
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Trial Identification
Brief Title: A Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Advanced Malignancies
Official Title: A Phase 1 Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Advanced Malignancies
Study ID: NCT03629756
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Scottsdale Healthcare Hospitals dba HonorHealth, Scottsdale, Arizona, United States
University of California, Los Angeles, Los Angeles, California, United States
The Angeles Clinic and Research Institute, Los Angeles, California, United States
Rocky Mountain Cancer Centers (Midtown), Denver, Colorado, United States
University of Michigan, Ann Arbor, Michigan, United States
QUEST Research Institute, Royal Oak, Michigan, United States
Carolina BioOncology Institute, Huntersville, North Carolina, United States
Prisma Health, Greenville, South Carolina, United States
Texas Oncology, P.A. - Fort Worth Cancer Center, Fort Worth, Texas, United States
Texas Oncology, P.A. - San Antonio Medical Center, San Antonio, Texas, United States
Texas Oncology, P.A. - Tyler, Tyler, Texas, United States
Medical Oncology Associates dba Summit Cancer Centers, Spokane, Washington, United States
St. George Private Hospital, Kogarah, New South Wales, Australia
Gallipoli Medical Research Foundation, Greenslopes, Queensland, Australia
Cabrini Health Limited, Malvern, , Australia
Contact Details
Name: Medical Director
Affiliation: Arcus Biosciences, Inc.
Role: STUDY_DIRECTOR
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