Study on ETX-636 for Adults with Advanced Solid Tumors
Sponsor: Ensem Therapeutics
ClinicalTrials ID:NCT06993844
This clinical trial is testing a new drug, ETX-636, to see if it is safe and effective for treating advanced solid tumors, including certain types of breast cancer. The study will explore different doses and combinations of the drug.
Patient Parameters
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Program Overview
This study is investigating a new treatment called ETX-636 for adults with advanced solid tumors that have a specific genetic mutation (PIK3CA). The trial is divided into three parts: Part A will test different doses of ETX-636 alone, Part B will test it in combination with another drug called fulvestrant for certain breast cancer patients, and Part C will expand on the combination treatment for breast cancer. Each part includes a 28-day screening period before starting the treatment.
Description
This clinical trial is designed to evaluate the safety and effectiveness of a new drug, ETX-636, in adults with advanced solid tumors that have a PIK3CA mutation. The study is divided into three parts:
- Part A: Tests increasing doses of ETX-636 alone in patients with advanced solid tumors.
- Part B: Tests increasing doses of ETX-636 combined with a fixed dose of fulvestrant in patients with hormone receptor-positive (HR+), HER2-negative (HER2-) advanced or metastatic breast cancer.
- Part C: Expands the combination treatment for patients with HR+, HER2- advanced or metastatic breast cancer.
Each part of the study includes a 28-day screening period, followed by treatment with either ETX-636 alone or in combination with fulvestrant.
Eligibility Criteria
Inclusion Criteria
- Have a solid tumor that has spread or cannot be removed by surgery and has worsened after at least one treatment.
- The tumor must have a specific PIK3CA mutation, found in either tumor tissue or blood.
- Have at least one tumor that can be measured or evaluated.
- Be in good overall health with a performance status score of 0 or 1.
- Have good organ function.
Additional criteria for Parts B and C:
- Have confirmed advanced or metastatic HR+/HER2- breast cancer that cannot be surgically removed and have received at least one prior CDK4/6 inhibitor and one prior anti-estrogen therapy.
Exclusion Criteria
- Have had a different type of cancer within the last 2 years.
- Have cancer that has spread to the brain or spine and is causing symptoms or is not controlled.
- Have uncontrolled diabetes or type 1 diabetes.
- Have received any cancer treatment within 14 days before starting the study treatment.
- Have side effects from previous cancer treatments that have not returned to normal, except for hair loss and nerve damage.
- Have had radiation therapy outside the target tumor area within 14 days before starting the study 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 |
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