A Study of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAB801 and Docetaxel

The study team can explain what participation involves.

Who it may be forAdvanced Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 9, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Completed

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What kind of study?Phase 1

Interventional

Where is it offered?10 U.S. locations

Locations may change over time.

Who runs it?Arcus Biosciences, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Arcus Biosciences, Inc.
Interventions being studied: Drug: AB801; Drug: Docetaxel

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Key
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

Reasons someone may not be able to joinExclusion 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/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Research SiteDenver, Colorado
Research SiteWashington D.C., District of Columbia
Research SiteAtlanta, Georgia
Research SiteGrand Rapids, Michigan
Research SiteNew York, New York
Research SitePhiladelphia, Pennsylvania
Research SiteDallas, Texas
Research SiteSan Antonio, Texas
Research SiteWest Valley City, Utah
Research SiteFairfax, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 9, 2026. Always confirm current availability with the study team.

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