Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors
NCT ID: NCT06993844
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
233 participants
INTERVENTIONAL
2025-06-10
2027-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies
NCT06395519
PTX-35 in Patients With Advanced Solid Tumors
NCT04430348
A Phase I Open-label Study for Subjects With Advanced Malignancies
NCT04136834
Study of PM060184 in Patients With Advanced Solid Tumors
NCT01299636
A Phase 1 of CTX-8371 in Patients With Advanced Malignancies
NCT06150664
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
ETX-636 dose escalation
ETX-636 is a pan-mutant-selective PI3Kα Inhibitor and degrader in the form of an oral tablet that will be taken once per day in 28-day cycles, to evaluate escalating dose levels.
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.
ETX-636 dose escalation in combination with fulvestrant
ETX-636 is a pan-mutant-selective PI3Kα Inhibitor and degrader in the form of an oral tablet. ETX-636 will be taken in combination with fulvestrant in 28-day cycles, to evaluate escalating dose levels. EXT-636 is an oral tablet that will be taken once per day. Fulvestrant will be administered as an injection 2 weeks apart in the first 28 days, followed by monthly injections.
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.
ETX-636 dose expansion in combination with fulvestrant
ETX-636 is a pan-mutant-selective PI3Kα Inhibitor and degrader in the form of an oral tablet. ETX-636 will be taken in combination with fulvestrant in 28-day cycles, to expand selected dose levels. EXT-636 is an oral tablet that will be taken once per day. Fulvestrant will be administered as an injection 2 weeks apart in the first 28 days, followed by monthly injections.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ETX-636 dose escalation
ETX-636 is a pan-mutant-selective PI3Kα Inhibitor and degrader in the form of an oral tablet that will be taken once per day in 28-day cycles, to evaluate escalating dose levels.
ETX-636 dose escalation in combination with fulvestrant
ETX-636 is a pan-mutant-selective PI3Kα Inhibitor and degrader in the form of an oral tablet. ETX-636 will be taken in combination with fulvestrant in 28-day cycles, to evaluate escalating dose levels. EXT-636 is an oral tablet that will be taken once per day. Fulvestrant will be administered as an injection 2 weeks apart in the first 28 days, followed by monthly injections.
ETX-636 dose expansion in combination with fulvestrant
ETX-636 is a pan-mutant-selective PI3Kα Inhibitor and degrader in the form of an oral tablet. ETX-636 will be taken in combination with fulvestrant in 28-day cycles, to expand selected dose levels. EXT-636 is an oral tablet that will be taken once per day. Fulvestrant will be administered as an injection 2 weeks apart in the first 28 days, followed by monthly injections.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ensem Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Yale University, Yale Cancer Center
New Haven, Connecticut, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Carolina BioOncology Institute
Huntersville, North Carolina, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
START
San Antonio, Texas, United States
NEXT
Fairfax, Virginia, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jordi Rodon Ahnert, MD, PhD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ETX636-C-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.