A Study of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
ARC-27
A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
1 other identifier
interventional
91
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2024
Typical duration for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2023
CompletedFirst Posted
Study publicly available on registry
November 7, 2023
CompletedStudy Start
First participant enrolled
January 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
May 1, 2026
April 1, 2026
2.8 years
November 1, 2023
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Adverse Events
Up to 2 years
Dose Escalation Cohorts: Number of Participants With Dose-Limiting Toxicities (DLTs)
Up to 2 years
Secondary Outcomes (5)
Area Under the Plasma Drug Concentration-Time Curve (AUC)
Predose, Up to 8 hours postdose
Maximum Concentration (Cmax) in Plasma
Predose, Up to 8 hours postdose
Time to Maximum Concentration (Tmax) in Plasma
Predose, Up to 8 hours postdose
Objective response rate (ORR) as Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Up to 2 years
Dose Expansion Cohorts: Duration of Response (DOR) as Assessed per RECIST v1.1
Up to 2 years
Study Arms (8)
Dose Escalation Cohort 1 - AB801 capsule Dose Level 1
EXPERIMENTALParticipants will receive AB801 orally daily
Dose Escalation Cohort 2 - AB801 capsule Dose Level 2
EXPERIMENTALParticipants will receive AB801 orally daily
Dose Escalation Cohort 3 - AB801 capsule Dose Level 3
EXPERIMENTALParticipants will receive AB801 orally daily
Dose Escalation Cohort 4 - AB801 capsule Dose Level 4
EXPERIMENTALParticipants will receive AB801 orally daily
Dose Escalation Cohort 5 - AB801 tablets Dose Level 5
EXPERIMENTALParticipants will receive AB801 orally daily
Dose Escalation Cohort 6 - AB801 tablets Dose Level 6
EXPERIMENTALParticipants will receive AB801 orally daily
Dose Escalation Cohort 7 - AB801 tablets Dose Level 7
EXPERIMENTALParticipants will receive AB801 orally daily
Dose Expansion Cohort - AB801 + Docetaxel
EXPERIMENTALParticipants with NSCLC will receive AB801 orally in combination with docetaxel IV infusion
Interventions
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Research Site
Denver, Colorado, 80218, United States
Research Site
Washington D.C., District of Columbia, 20007, United States
Research Site
Atlanta, Georgia, 30322, United States
Research Site
Grand Rapids, Michigan, 49546, United States
Research Site
New York, New York, 10128, United States
Research Site
Philadelphia, Pennsylvania, 19104, United States
Research Site
Dallas, Texas, 75230, United States
Research Site
San Antonio, Texas, 78229, United States
Research Site
West Valley City, Utah, 84119, United States
Research Site
Fairfax, Virginia, 22031, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Arcus Biosciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2023
First Posted
November 7, 2023
Study Start
January 19, 2024
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \[SAP\], Clinical Study Report \[CSR\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.