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 Sex
- 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 |
|
|
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. |
|
|
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. |
|
Recruiting Locations
Hoag Memorial Hospital Presbyterian
Newport Beach 5376890, California 5332921 92663
Newport Beach 5376890, California 5332921 92663
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco 5391959, California 5332921 94158
San Francisco 5391959, California 5332921 94158
Yale University, Yale Cancer Center
New Haven 4839366, Connecticut 4831725 06520
New Haven 4839366, Connecticut 4831725 06520
Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215
Boston 4930956, Massachusetts 6254926 02215
Carolina BioOncology Institute
Huntersville 4472370, North Carolina 4482348 28078
Huntersville 4472370, North Carolina 4482348 28078
The University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
Contact:
Jordi Rodon Ahnert, MD, PhD
713-792-5603
Jordi Rodon Ahnert, MD, PhD
713-792-5603
START
San Antonio 4726206, Texas 4736286 78229
San Antonio 4726206, Texas 4736286 78229
NEXT
Fairfax 4758023, Virginia 6254928 22031
Fairfax 4758023, Virginia 6254928 22031
Fred Hutchinson Cancer Center
Seattle 5809844, Washington 5815135 98109
Seattle 5809844, Washington 5815135 98109
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.