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Clinical Trials in Israel / NCT06993844
Recruiting Phase 1/2

Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors

NCT06993844 · tracked via the Priya Life Science Israel tracker
Sponsor
Ensem Therapeutics
Phase
Phase 1/2
Started
2025-06-10
Last updated
2026-10-13

Condition(s) studied

Advanced Solid TumorsAdvanced Breast Cancer

Investigational drug(s) / intervention(s)

ETX-636 dose escalationETX-636 dose escalation in combination with fulvestrant →ETX-636 dose expansion in combination with fulvestrant →

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.

Study summary

Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Evaluate Safety and Tolerability of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B — First 28 days of treatment
    Proportion of participants who experience at least 1 Dose Limiting Toxicity (DLT)
  • Evaluate Safety and Tolerability of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B — Average of 6 months
    Incidence of AEs, treatment discontinuations due to AEs, changes from baseline in laboratory assessments, ECGs and vital signs.
  • Select the Recommended Phase 2 Dose(s) (RP2D) in Part B to be further explored in Part C (combination therapy expansion) — Average of 6 months
    Safety Parameters as described for primary outcomes
  • Evaluate efficacy of ETX-636 plus fulvestrant combination therapy at the RP2D(s) in Part C — Average of 6 months
    ORR and CBR according to RECIST v1.1

Trial sites (15)

FacilityCityRegionStatus
Hoag Memorial Hospital Presbyterian Newport Beach California Recruiting
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California Recruiting
Yale University, Yale Cancer Center New Haven Connecticut Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
Carolina BioOncology Institute Huntersville North Carolina Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas Recruiting
START San Antonio Texas Recruiting
NEXT Fairfax Virginia Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting
Beijing Luhe Hospital,Capital Medical University Beijing China Recruiting
Fujian Cancer Hospital Fuzhou China Recruiting
Sun Yat-sen University Cancer Center Guangzhou China Recruiting
Shandong Cancer Hospital&Institute Shandong China Recruiting
Fudan University Shanghai Cancer Hospital Shanghai China Recruiting

Other trials for the same condition

A Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors (MK-3120-002) Recruiting
A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001) Recruiting
Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid Tumors Recruiting
Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors Recruiting
Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06993844 on ClinicalTrials.gov ↗ ← All trials in Israel