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

Study Identifier:
ARC-27
CT.gov Identifier:
NCT06120075
EudraCT Identifier:
202351000000
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Unspecified Cancer
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Dose Escalation Cohort 1 - AB801 capsule Dose Level 1
    • Read More
  • Drug: Experimental: Dose Escalation Cohort 2 - AB801 capsule Dose Level 2
  • Drug: Experimental: Dose Escalation Cohort 3 - AB801 capsule Dose Level 3
  • Drug: Experimental: Dose Escalation Cohort 4 - AB801 capsule Dose Level 4
  • Drug: Experimental: Dose Escalation Cohort 5 - AB801 tablets Dose Level 5
  • Drug: Experimental: Dose Escalation Cohort 6 - AB801 tablets Dose Level 6
  • Drug: Experimental: Dose Escalation Cohort 7 - AB801 tablets Dose Level 7
  • Drug: Experimental: Dose Expansion Cohort - AB801 + Docetaxel
  • Drug: Drug: Docetaxel
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    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- 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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    Justin Call
    Status
    Recruiting
    Condition(s) Treated at Site
    Unspecified Cancer
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Nehal Lakhani
    Status
    Recruiting
    Condition(s) Treated at Site
    Unspecified Cancer
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Amita Patnaik
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Unspecified Cancer