ClinicalTrials.gov record
Recruiting Phase 1Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT06993844

Public ClinicalTrials.gov record NCT06993844. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 8, 2026, 7:48 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT06993844
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Ensem Therapeutics
Industry
Enrollment
233 participants

Conditions and interventions

Interventions

  • ETX-636 dose escalation Drug
  • ETX-636 dose escalation in combination with fulvestrant Drug
  • ETX-636 dose expansion in combination with fulvestrant Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 9, 2025
Primary completion
Jun 29, 2027
Completion
Dec 29, 2027
Last update posted
May 5, 2026

2025 – 2027

United States locations

U.S. sites
10
U.S. states
7
U.S. cities
9
Facility City State ZIP Site status
Hoag Memorial Hospital Presbyterian Newport Beach California 92663 Recruiting
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California 94158 Recruiting
Yale University, Yale Cancer Center New Haven Connecticut 06520 Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 Recruiting
Dana-Farber Cancer Institute Boston Massachusetts 02215 Recruiting
Carolina BioOncology Institute Huntersville North Carolina 28078 Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas 77030 Recruiting
START San Antonio Texas 78229 Recruiting
NEXT Fairfax Virginia 22031 Recruiting
Fred Hutchinson Cancer Center Seattle Washington 98109 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06993844, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 5, 2026 · Synced May 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06993844 live on ClinicalTrials.gov.

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