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