Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors
Sponsor: Ensem Therapeutics
ClinicalTrials ID:NCT06993844
This Phase 1/2 open-label study evaluates ETX-636's safety, tolerability, PK, PD, and efficacy in advanced solid tumors with PIK3CA mutations. Part A involves ETX-636 monotherapy; Parts B and C assess combination with fulvestrant in HR+/HER2- breast cancer. Eligible participants have progressed on prior therapies, possess measurable disease, and meet specific health criteria.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors
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.
Eligibility 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.
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Hoag Memorial Hospital Presbyterian | 92663 | Newport Beach | California |
| UCSF Helen Diller Family Comprehensive Cancer Center | 94158 | San Francisco | California |
| Carolina BioOncology Institute | 28078 | Huntersville | North Carolina |
| The University of Texas MD Anderson Cancer Center | 77030 | Houston | Texas |
| START | 78229 | San Antonio | Texas |
| NEXT | 22031 | Fairfax | Virginia |
Get This Program In Your Inbox
You can sign up and apply your patients for this program.