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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06120075
Other study ID # ARC-27
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date January 19, 2024
Est. completion date November 2026

Study information

Verified date June 2024
Source Arcus Biosciences, Inc.
Contact Medical Director
Phone 1-888-44-ARCUS
Email ClinicalTrials@arcusbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date November 2026
Est. primary completion date November 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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 Cohort 1 (STK11m [mutated or deleted] NSCLC): - Cytologically or pathologically confirmed locally advanced unresectable or metastatic (Stage IIIB-IV per American Joint Committee on Cancer [AJCC] version 8) non-squamous NSCLC with documented mutation or deletion in the STK11 gene. - Negative for actionable mutations including epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), c-ros oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), mesenchymal-epithelial transition factor (C-MET) or ret proto-oncogene (RET). Mixed small-cell lung carcinoma (SCLC) and squamous NSCLC histology is not permitted. - Previously treated in the unresectable locally advanced or metastatic setting with a platinum-containing chemotherapy and programmed cell death ligand-1 (PD-L1) inhibitor. - Disease-specific criteria for dose-expansion Cohort 2 (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-a 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


Related Conditions & MeSH terms


Intervention

Drug:
AB801
Administered as specified in the treatment arm
Zimberelimab
Administered as specified in the treatment arm
Docetaxel
Administered as specified in the treatment arm

Locations

Country Name City State
United States Mary Crowley Dallas Texas
United States Sarah Cannon Research Institute Denver Colorado
United States Next Oncology Virginia Fairfax Virginia
United States START MIdwest Grand Rapids Michigan
United States Icahn School of Medicine at Mount Sinai/ The Tisch Cancer Cente New York New York
United States START - South Texas Accelerated Research Theraputics, LLC. San Antonio Texas
United States START Mountain Region West Valley City Utah

Sponsors (1)

Lead Sponsor Collaborator
Arcus Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Adverse Events Up to 2 years
Primary Dose Escalation Cohorts: Number of Participants With Dose-Limiting Toxicities (DLTs) Up to 2 years
Secondary Area Under the Plasma Drug Concentration-Time Curve (AUC) Predose, Up to 8 hours postdose
Secondary Maximum Concentration (Cmax) in Plasma Predose, Up to 8 hours postdose
Secondary Time to Maximum Concentration (Tmax) in Plasma Predose, Up to 8 hours postdose
Secondary Objective response rate (ORR) as Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Up to 2 years
Secondary Dose Expansion Cohorts: Duration of Response (DOR) as Assessed per RECIST v1.1 Up to 2 years
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