Testing AB801 for advanced cancers

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

This study is testing a new treatment called AB801, alone and with another drug, to see if it can help people with advanced cancers, especially those who haven't had success with other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 91 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Arcus Biosciences, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation, methotrexate, cyclophosphamide
• Locations: 10 sites (Denver, Colorado and 9 other locations)
• Trial ID: NCT06120075 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of AB801, both as a standalone treatment and in combination with Docetaxel, for patients with advanced malignancies. It aims to identify the appropriate dosage of AB801 for further development. Participants include those with various types of advanced cancer, particularly non-small cell lung cancer (NSCLC), who have not responded to existing therapies. The study is designed to provide insights into the effectiveness of AB801 in this challenging patient population.

Who should consider this trial

Good fit: Ideal candidates are patients with advanced malignancies, particularly those with non-small cell lung cancer that has progressed despite standard treatments.

Not a fit: Patients with early-stage cancers or those who have not yet undergone standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced cancers that have limited treatment choices.

How similar studies have performed: Other studies have shown promise with similar investigational agents in treating advanced cancers, suggesting potential for success with this approach.

Eligibility criteria

Key Inclusion Criteria:

* 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.
* 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.
* 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.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Key Exclusion Criteria:

* 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.

Where this trial is running

Denver, Colorado and 9 other locations

• Sarah Cannon Research Institute — Denver, Colorado, United States (Recruiting)
• Georgetown — Washington, District of Columbia, United States (Recruiting)
• Emory University — Atlanta, Georgia, United States (Recruiting)
• START Midwest — Grand Rapids, Michigan, United States (Recruiting)
• Icahn School of Medicine at Mount Sinai/ The Tisch Cancer Center — New York, New York, United States (Recruiting)
• University Of Pennsylvania, Abramson Cancer Center — Philadelphia, Pennsylvania, United States (Recruiting)
• Mary Crowley — Dallas, Texas, United States (Recruiting)
• START - South Texas Accelerated Research Therapeutics, LLC. — San Antonio, Texas, United States (Recruiting)
• START Mountain Region — West Valley City, Utah, United States (Recruiting)
• Next Oncology Virginia — Fairfax, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Medical Director

Conditions Advanced Cancer; AB801; Non-small cell lung cancer