Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors
About this study
Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors
- Condition
- Advanced Solid Tumors, Advanced Breast Cancer
- Tested
- ETX-636 dose escalation, ETX-636 dose escalation in combination with fulvestrant, ETX-636 dose expansion in combination...
- Sponsor
- Ensem Therapeutics
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 9
- Minimum age: 18 years
- Study condition: Advanced Solid Tumors, Advanced Breast Cancer
- 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 6
- 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.
Where
15 sites, 15 recruiting
Beijing Luhe Hospital,Capital Medical University
Beijing, China
Fujian Cancer Hospital
Fuzhou, China
Sun Yat-sen University Cancer Center
Guangzhou, China
Shandong Cancer Hospital&Institute
Shandong, China
Fudan University Shanghai Cancer Hospital
Shanghai, China
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
and 9 more sites on ClinicalTrials.gov
Contact
-
Janaki Parameswaran, MD
1-617-383-4993 janaki.parameswaran@Ensemtx.com
-
Melinda Snyder
1-617-383-4993 melinda.snyder-ext@Ensemtx.com
Potential match only. Final eligibility is determined by the study team.