A Study of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
NCT ID: NCT06120075
Last Updated: 2026-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
91 participants
INTERVENTIONAL
2024-01-19
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Expansion Cohort - AB801 + Docetaxel
Participants with NSCLC will receive AB801 orally in combination with docetaxel IV infusion
AB801
Administered as specified in the treatment arm
Docetaxel
Administered as specified in the treatment arm
Dose Escalation Cohort 1 - AB801 capsule Dose Level 1
Participants will receive AB801 orally daily
AB801
Administered as specified in the treatment arm
Dose Escalation Cohort 2 - AB801 capsule Dose Level 2
Participants will receive AB801 orally daily
AB801
Administered as specified in the treatment arm
Dose Escalation Cohort 3 - AB801 capsule Dose Level 3
Participants will receive AB801 orally daily
AB801
Administered as specified in the treatment arm
Dose Escalation Cohort 4 - AB801 capsule Dose Level 4
Participants will receive AB801 orally daily
AB801
Administered as specified in the treatment arm
Dose Escalation Cohort 5 - AB801 tablets Dose Level 5
Participants will receive AB801 orally daily
AB801
Administered as specified in the treatment arm
Dose Escalation Cohort 6 - AB801 tablets Dose Level 6
Participants will receive AB801 orally daily
AB801
Administered as specified in the treatment arm
Dose Escalation Cohort 7 - AB801 tablets Dose Level 7
Participants will receive AB801 orally daily
AB801
Administered as specified in the treatment arm
Interventions
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AB801
Administered as specified in the treatment arm
Docetaxel
Administered as specified in the treatment arm
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Arcus Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Arcus Biosciences
Locations
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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
Countries
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Related Links
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ARC-27 - Public website
Other Identifiers
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ARC-27
Identifier Type: -
Identifier Source: org_study_id
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