A Study of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
- Registration Number
- NCT06120075
- Lead Sponsor
- Arcus Biosciences, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 91
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Monotherapy-specific criteria for dose escalation cohorts:
- Participants 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.
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Disease-specific criteria for dose-expansion (NSCLC):
- Cytologically 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.
- Previously treated in the unresectable locally advanced or metastatic setting with a platinum-containing chemotherapy and PD-(L)-1inhibitor.
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Must 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.
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Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Key
- Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product.
- Underlying medical conditions or adverse events that, in the physician or sponsor's opinion, will make the administration of investigational products hazardous.
- Prolonged QT interval defined as mean corrected QT interval (QTc) ≥ 450 milliseconds (ms).
- Any 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.
- Treatment 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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation Cohort 1 - AB801 capsule Dose Level 1 AB801 Participants will receive AB801 orally daily Dose Escalation Cohort 2 - AB801 capsule Dose Level 2 AB801 Participants will receive AB801 orally daily Dose Escalation Cohort 4 - AB801 capsule Dose Level 4 AB801 Participants will receive AB801 orally daily Dose Escalation Cohort 5 - AB801 tablets Dose Level 5 AB801 Participants will receive AB801 orally daily Dose Expansion Cohort - AB801 + Docetaxel AB801 Participants with NSCLC will receive AB801 orally in combination with docetaxel IV infusion Dose Expansion Cohort - AB801 + Docetaxel Docetaxel Participants with NSCLC will receive AB801 orally in combination with docetaxel IV infusion Dose Escalation Cohort 6 - AB801 tablets Dose Level 6 AB801 Participants will receive AB801 orally daily Dose Escalation Cohort 7 - AB801 tablets Dose Level 7 AB801 Participants will receive AB801 orally daily Dose Escalation Cohort 3 - AB801 capsule Dose Level 3 AB801 Participants will receive AB801 orally daily
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events Up to 2 years Dose Escalation Cohorts: Number of Participants With Dose-Limiting Toxicities (DLTs) Up to 2 years
- Secondary Outcome Measures
Name Time Method Area Under the Plasma Drug Concentration-Time Curve (AUC) Predose, Up to 8 hours postdose Maximum Concentration (Cmax) in Plasma Predose, Up to 8 hours postdose Objective response rate (ORR) as Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Up to 2 years Dose Expansion Cohorts: Duration of Response (DOR) as Assessed per RECIST v1.1 Up to 2 years Time to Maximum Concentration (Tmax) in Plasma Predose, Up to 8 hours postdose
Trial Locations
- Locations (7)
Icahn School of Medicine at Mount Sinai/ The Tisch Cancer Center
🇺🇸New York, New York, United States
START - South Texas Accelerated Research Therapeutics, LLC.
🇺🇸San Antonio, Texas, United States
Sarah Cannon Research Institute
🇺🇸Denver, Colorado, United States
Emory University
🇺🇸Atlanta, Georgia, United States
START Midwest
🇺🇸Grand Rapids, Michigan, United States
START Mountain Region
🇺🇸West Valley City, Utah, United States
Next Oncology Virginia
🇺🇸Fairfax, Virginia, United States