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Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors

Sponsored by Ensem Therapeutics

About this study

Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors

Brief Summary: This is a Phase 1/2, open-label, multicenter, 3-part study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of ETX-636 in participants with advanced solid tumors harboring a PIK3CA mutation. Part A will evaluate escalating doses of ETX-636 as monotherapy in participants with advanced solid tumors. Part B will evaluate escalating doses of ETX-636 as combination therapy with fixed dose fulvestrant in participants with hormone receptor positive (HR+), HER2 negative (HER2-) locally advanced or metastatic breast cancer. Part C will be a combination therapy expansion in participants with HR+, HER2- locally advanced or metastatic breast cancer. Each study part will include a 28-day screening period, followed by treatment with ETX-636 monotherapy or combinati…

Where this study is enrolling (10)

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California

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  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California

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  • Yale University, Yale Cancer Center

    New Haven, Connecticut

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  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts

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  • Dana-Farber Cancer Institute

    Boston, Massachusetts

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Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.