A Phase I/II Open-label Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of GTAEXS617 in Patients With Advanced Solid Tumors

Study Identifier:
GTAEXS617-001
CT.gov Identifier:
NCT05985655
EudraCT Identifier:
2022-003475-42
EU Trial (CTIS) Number:
2023-508227-13-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

To assess the safety, tolerability, pharmacokinetics and anti-tumor activity of GTAEXS617-001 in patients with advanced solid tumors.

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.
  • Head & Neck
  • Pancreas
  • Non-Small Cell Lung Cancer
  • Ovarian
  • Primary Peritoneal
  • Fallopian Tube
  • Breast Cancers
    • 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/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Phase 1: Dose Escalation Monotherapy
    • Read More
  • Drug: Experimental: Phase 1: Dose Escalation Combination Therapy
  • Drug: Experimental: Phase 2: Dose Expansion Combination Therapy
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • - ECOG performance status 0-1
    • - Life expectancy >3 months
    • - One the following histologically or cytologically confirmed advanced solid tumors:
    • head and neck squamous cell carcinoma, colorectal adenocarcinoma, pancreatic
    • adenocarcinoma, NSCLC, breast carcinoma (HR+ and HER2- that has progressed to a prior
    • treatment with CD4/CDK6 inhibitor), or ovarian epithelial carcinoma
    • - Patients must have disease that is advanced (ie, surgery or radiotherapy are not
    • considered to be potentially curative), recurrent, or metastatic following SoC
    • treatments
    • - Adequate hematological, liver, and renal function
    • - Participant must have tumor lesion(s) or metastases amenable to biopsy, excluding bone
    • metastases
    Exclusion criteria
    • - Active and clinically significant (CS) infection
    • - Refractory nausea and/or vomiting, chronic gastrointestinal disease, or previous
    • significant bowel resection, with CS sequelae that would preclude adequate absorption
    • of GTAEXS617
    • - Symptomatic central nervous system (CNS) malignancy or metastases
    • - Concurrent active or previous malignancy
    • - Prior organ or allogeneic stem-cell transplantation
    • - Moderate or severe cardiovascular disease
    • - Received anticancer therapy within 28 days or 5 half-lives (whichever is shorter)
    • before the first dose of the study treatment
    • - Received treatment with known strong inhibitors and or inducers of cytochrome P450 3A
    • isoform subfamily (CYP3A) within 14 days or 5 half-lives before the first dose of
    • study treatment
    • - Received treatment with known inhibitors or inducers of P-glycoprotein (P-gp) or
    • breast cancer resistance protein (BCRP) within 14 days or 5 half-lives before the
    • first dose of study
    • - Received treatment with known substrates of organic anion transporting peptide 1B3
    • (OATP1B3) or BCRP within 14 days or 5 half-lives before the first dose of study
    • treatment
    • - Unresolved or unstable serious toxic side-effects of prior chemotherapy or
    • radiotherapy
    • - Has had or is scheduled to have major surgery <28 days prior to the first dose of
    • study treatment

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Kyriakos Papadopoulos
    Status
    Recruiting
    Condition(s) Treated at Site
    Head & Neck
    Pancreas
    Non-Small Cell Lung Cancer
    Ovarian
    Primary Peritoneal
    Fallopian Tube
    Breast Cancers
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    William McKean
    Status
    Recruiting
    Condition(s) Treated at Site
    Head & Neck
    Pancreas
    Non-Small Cell Lung Cancer
    Ovarian
    Primary Peritoneal
    Fallopian Tube
    Breast Cancers
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Manish Sharma
    Status
    Recruiting
    Condition(s) Treated at Site
    Head & Neck
    Pancreas
    Non-Small Cell Lung Cancer
    Ovarian
    Primary Peritoneal
    Fallopian Tube
    Breast Cancers