Status:
RECRUITING
Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors
Lead Sponsor:
Ensem Therapeutics
Conditions:
Advanced Solid Tumors
Advanced Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors
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 h...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
June 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT06993844
Start Date
June 10 2025
End Date
December 30 2027
Last Update
January 5 2026
Active Locations (9)
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1
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
2
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
3
Yale University, Yale Cancer Center
New Haven, Connecticut, United States, 06520
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215