Loading clinical trials...

A Study of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

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

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

NCT06120075•Arcus Biosciences, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

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.

Locations (10)

Sarah Cannon Research Institute

Denver, Colorado, United States

Georgetown

Washington D.C., District of Columbia, United States

Emory University

Atlanta, Georgia, United States

START Midwest

Grand Rapids, Michigan, United States

Icahn School of Medicine at Mount Sinai/ The Tisch Cancer Center

New York, New York, United States

University Of Pennsylvania, Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Mary Crowley

Dallas, Texas, United States

START - South Texas Accelerated Research Therapeutics, LLC.

San Antonio, Texas, United States

START Mountain Region

West Valley City, Utah, United States

Next Oncology Virginia

Fairfax, Virginia, United States

Key Dates

Start Date

January 19, 2024

Primary Completion Date

November 1, 2026

Completion Date

November 1, 2026

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Advanced Cancer

Interventions

AB801

DRUG

Docetaxel

DRUG

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

NCT04657068

Advanced CancerMetastatic Cancer+7 more

View study

RECRUITINGPHASE1

Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors

NCT04900818

Solid TumorAdvanced Cancer+6 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors

A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer

A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors

A Chaplain-clinician Led Spiritual Care (PEACE) Intervention on Spiritual/Religious Beliefs Related to Medical Care in Patients With Advanced Cancer: a Pilot Clinical Trial

A Study of MGC026 in Participants With Advanced Solid Tumors