ETX-636 treatment for advanced PIK3CA-mutant solid tumors and HR+ HER2- breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1/2, open-label, multicenter, three-part trial testing escalating doses of the oral PI3Kα inhibitor ETX-636 as monotherapy (Part A) and in combination with fixed-dose fulvestrant (Parts B and C) in participants with advanced solid tumors harboring activating PIK3CA mutations. The trial will first determine safety, tolerability, pharmacokinetics, and pharmacodynamics during dose escalation and then expand the combination cohort in HR+, HER2- locally advanced or metastatic breast cancer. Key eligibility includes measurable disease, ECOG 0-1, adequate organ function, and for the breast cancer cohorts prior CDK4/6 inhibitor and anti-estrogen therapy. Endpoints include dose-limiting toxicities, recommended phase 2 dose, and preliminary anti-tumor activity by RECIST v1.1.

Why it matters

Who can join: the full rules

Key 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.

Key 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.

Where it's running

• Hoag Memorial Hospital Presbyterian
  Newport Beach, California, United States Recruiting
• UCSF Helen Diller Family Comprehensive Cancer Center
  San Francisco, California, United States Recruiting
• Yale University, Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Carolina BioOncology Institute
  Huntersville, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Lori Cykowski
• Email: lori.cykowski@Ensemtx.com
• Phone: 1-617-383-4993

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.