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Back|NCT06120075Recruiting
Official Title

A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies

Phase
Phase 1
Sponsor
Arcus Biosciences, Inc.
Enrollment
91
Timeline
Jan 2024 → Nov 2026
About This Study

The primary purpose of this study is to assess the safety and tolerability of AB801 in participants with advanced malignancies, and to determine a recommended AB801 dose for expansion.

Eligibility Criteria

Inclusion Criteria

  • 1Monotherapy-specific criteria for dose escalation cohorts:
  • 2Participants may have cytologically or pathologically confirmed non-small cell lung carcinoma (NSCLC), colorectal carcinoma (CRC), breast, ovarian, renal cell carcinoma (RCC), head and neck squamous cell carcinoma (HNSCC), or bladder (including urothelial malignancies of the renal pelvis and ureter) carcinoma that has progressed or was non-responsive to available therapies with no standard of care (SOC) options, or for whom standard therapy has proven ineffective, intolerable, or considered inappropriate; or for whom a clinical study of an investigational agent is a recognized SOC.
  • 3Disease-specific criteria for dose-expansion (NSCLC):
  • 4Cytologically or pathologically confirmed locally advanced unresectable or metastatic (Stage IIIB-IV per American Joint Committee on Cancer version 8) non-squamous NSCLC negative for actionable mutations in EGFR, ALK, ROS1, NTRK, C-MET, or RET. Mixed SCLC and squamous NSCLC histology is not permitted.
  • 5Previously treated in the unresectable locally advanced or metastatic setting with a platinum-containing chemotherapy and PD-(L)-1inhibitor.
  • 6Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) guidance (Version 1.1) (Section 1.1). The measurable lesion must be outside of a radiation field if the participant received prior radiation unless discussed and approved by the study physician.
  • 7Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Exclusion Criteria

  • 1Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product.
  • 2Underlying medical conditions or adverse events that, in the physician or sponsor's opinion, will make the administration of investigational products hazardous.
  • 3Prolonged QT interval defined as mean corrected QT interval (QTc) ≥ 450 milliseconds (ms).
  • 4Any active or documented history of autoimmune disease, including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment.
  • 5Treatment with systemic immunosuppressive medication (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor-α agents) administered within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressant medication during study treatment.

Locations

10 sites participating in this study

Emory University

Atlanta, Georgia 30322

Recruiting

Sarah Cannon Research Institute

Denver, Colorado 80218

Recruiting

Georgetown

Washington D.C., District of Columbia 20007

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