Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors
Purpose
Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors
Conditions
- Advanced Solid Tumors
- Advanced Breast Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- Fulvestrant
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part A Dose Escalation Monotherapy (Advanced Solid Tumors with PIK3CA mutation) |
Part A is a dose escalation monotherapy of ETX-636 in advanced solid tumors with PIK3CA mutation |
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Experimental Part B Dose Escalation Combination Therapy (HR+/HER2- locally advanced or metastatic breast cancer) |
Part B is a dose escalation combination therapy in HR+/HER2- locally advanced or metastatic breast cancer. The study treatment will be ETX-636, a pan-mutant-selective PI3Kα inhibitor, in combination with fulvestrant (Faslodex) at a fixed dose of 500 mg IM. |
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Experimental Part C Dose Expansion Combination Therapy (HR+/HER2- locally advanced or metastatic breast cancer) |
Part B is a dose expansion combination therapy in HR+/HER2- locally advanced or metastatic breast cancer. The study treatment will be ETX-636, a pan-mutant-selective PI3Kα inhibitor, in combination with fulvestrant (Faslodex) at a fixed dose of 500 mg IM. |
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Recruiting Locations
More Details
- NCT ID
- NCT06993844
- Status
- Recruiting
- Sponsor
- Ensem Therapeutics
Detailed Description
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 combination therapy.