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

Advanced Cancer Clinical Trial

— ARC-27  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06120075
• Other study ID #: ARC-27
• Status: Recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

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