Tests ETX-636 in adults with advanced solid tumors and breast cancer
Tests a new drug, ETX-636, in adults with advanced solid tumors or breast cancer.
Plain-language title generated from the registry record
Registry title: Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors
Key facts
- Where
- Boston, Fairfax, Houston, Huntersville, New Haven, Newport Beach, San Antonio, San Francisco, and Seattle, United StatesSee the 10 sites
- Phase
- Phase 1/2
Where in United States
- Beth Israel Deaconess Medical CenterBoston, United StatesTaking people
- Dana-Farber Cancer InstituteBoston, United StatesTaking people
- NEXTFairfax, United StatesTaking people
- The University of Texas MD Anderson Cancer CenterHouston, United StatesTaking people
- Carolina Biooncology InstituteHuntersville, United StatesTaking people
- Yale University, Yale Cancer CenterNew Haven, United StatesTaking people
- Hoag Memorial Hospital PresbyterianNewport Beach, United StatesTaking people
- STARTSan Antonio, United StatesTaking people
- UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, United StatesTaking people
- Fred Hutchinson Cancer CenterSeattle, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ensem Therapeutics
- Trial code
- NCT06993844
- Record updated
- 13 October 2026
- Original description
Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumorsRead full original descriptionShow less
A Phase 1/2, Open-label, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ETX-636, a Pan-mutant-selective PI3Kα Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies in Participants With Advanced Solid Tumors
Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors
Inclusion: 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: 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; 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 history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied.