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Official Title

A Phase 1, Open-label, Dose Escalation and Dose Expansion Study, to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB521 Monotherapy and Combination Therapies in Participants With Clear Cell Renal Cell Carcinoma and Other Solid Tumors

Phase
Phase 1
Sponsor
Arcus Biosciences, Inc.
Enrollment
302
Timeline
Oct 2022 → Jul 2027
About This Study

The purpose of this study is to evaluate the safety and tolerability of: * casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and * casdatifan monotherapy and casdatifan in combination with cabozantinib or zimberelimab in participants with ccRCC in the dose expansion stage

Eligibility Criteria

Inclusion Criteria

  • 1Must have at least one measurable lesion per RECIST guidance
  • 2Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1
  • 3Disease-specific criteria for dose escalation:
  • 4Participants may have any pathologically confirmed solid tumor type where no other treatment options are available
  • 5Creatinine clearance ≥ 40 mL/min
  • 6Disease-specific criteria for dose-expansion:
  • 7Histologically confirmed ccRCC
  • 8Creatinine clearance ≥ 40 mL/min

Exclusion Criteria

  • 1Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product
  • 2Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with a participant's participation in the clinical study or make the administration of investigational product hazardous
  • 3History of trauma or major surgery within 28 days prior to the first dose of investigational product
  • 4For all expansion cohorts: prior treatment with an hypoxia inducible factor (HIF)-2α inhibitor. For the casdatifan + cabozantinib combination cohort, any prior treatment with cabozantinib
  • 5Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Locations

27 sites participating in this study

Emory University

Atlanta, Georgia 30322-1013

Recruiting

University of Alabama at Birmingham

Birmingham, Alabama 35294

Recruiting

University of California at San Diego

San Diego, California 92093

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →