A Phase I/II, Open-label, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ETX-636, a Pan-mutant-selective PI3Kα Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies in Participants With Advanced Solid Tumors

Study Identifier:
ETX636-C-001-START
CT.gov Identifier:
NCT06993844
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

To evaluate the safety, tolerability, PK, PD, and preliminary efficacy of ETX-636 in participants with advanced solid tumors harboring a PIK3CA mutation.

To evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of ETX-636 in participants with advanced solid tumors harboring a PI3Kα mutation

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.
  • Breast
  • Solid Tumor
    • 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.
    Phase 1 and 2
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Part A Dose Escalation Monotherapy (Advanced Solid Tumors with PIK3CA mutation)
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  • Drug: Experimental: Part B Dose Escalation Combination Therapy (HR+/HER2- locally advanced or metastatic breast cancer)
  • Drug: Experimental: Part C Dose Expansion Combination Therapy (HR+/HER2- locally advanced or metastatic breast cancer)
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Inclusion Criteria:
    • Metastatic or locally advanced and unresectable solid tumor that has progressed on or after at least one available therapy.
    • Tumor harboring an activating PIK3CA mutation detected in either tumor tissue or ctDNA.
    • At least 1 measurable lesion or evaluable disease per RECIST v1.1.
    • An ECOG performance status score of 0 or 1.
    • Adequate organ function.
    • Additional key inclusion criterion for Parts B and C:
    • - Confirmed metastatic or locally advanced HR+/HER2- breast cancer not amenable to surgical resection with curative intent and must have received at least 1 prior CDK4/6 inhibitor and at least 1 prior anti-estrogen therapy.
    • Exclusion Criteria:
    • Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied.
    • Has symptomatic brain or spinal metastases or a known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement.
    • Has an established diagnosis of diabetes mellitus type 1 or has uncontrolled diabetes mellitus type 2.
    • Has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days prior to start of treatment.
    • Has toxicities from previous anticancer therapies that have not resolved to baseline levels with the exception of alopecia and peripheral neuropathy.
    • Has had radiotherapy outside the target tumor lesions within 14 days prior to start of 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
    Amita Patnaik
    Status
    Recruiting
    Condition(s) Treated at Site
    Breast
    Solid Tumor