Actively Recruiting
Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors
Led by Ensem Therapeutics · Updated on 2026-05-06
233
Participants Needed
15
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors
CONDITIONS
Official Title
Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- For Parts B and C: Confirmed metastatic or locally advanced HR+/HER2- breast cancer not amenable to surgical resection with curative intent
- For Parts B and C: Must have received at least 1 prior CDK4/6 inhibitor and at least 1 prior anti-estrogen therapy
You will not qualify if you...
- History within 2 years before screening of a solid tumor or hematological malignancy distinct from the cancers being studied
- Symptomatic brain or spinal metastases or known or suspected untreated or uncontrolled central nervous system involvement
- Established diagnosis of diabetes mellitus type 1 or uncontrolled diabetes mellitus type 2
- Treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days prior to start of treatment
- Toxicities from previous anticancer therapies not resolved to baseline levels except alopecia and peripheral neuropathy
- Radiotherapy outside the target tumor lesions within 14 days prior to start of treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
2
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
Actively Recruiting
3
Yale University, Yale Cancer Center
New Haven, Connecticut, United States, 06520
Actively Recruiting
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
Carolina BioOncology Institute
Huntersville, North Carolina, United States, 28078
Actively Recruiting
7
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
8
START
San Antonio, Texas, United States, 78229
Actively Recruiting
9
NEXT
Fairfax, Virginia, United States, 22031
Actively Recruiting
10
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
11
Beijing Luhe Hospital,Capital Medical University
Beijing, China
Actively Recruiting
12
Fujian Cancer Hospital
Fuzhou, China
Actively Recruiting
13
Sun Yat-sen University Cancer Center
Guangzhou, China
Actively Recruiting
14
Shandong Cancer Hospital&Institute
Shandong, China
Actively Recruiting
15
Fudan University Shanghai Cancer Hospital
Shanghai, China
Actively Recruiting
Research Team
J
Janaki Parameswaran, MD
CONTACT
M
Melinda Snyder
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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