Trials / Recruiting
RecruitingNCT07109726
A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 205 (estimated)
- Sponsor
- Terremoto Biosciences Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 1/2, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TER-2013 in patients with advanced solid tumors harboring AKT/PI3K/PTEN pathway alterations.
Detailed description
This is a first-in-human clinical trial that will evaluate the safety, tolerability, and pharmacokinetics (PK) of TER-2013 as a monotherapy and in combination with fulvestrant and to determine the maximum tolerated/administered dose and preliminary clinical activity. The study consists of two parts: Part 1-Dose Escalation and Part 2 -Dose Expansion.
Conditions
- Breast Cancer
- Endometrial Cancer
- Ovarian Cancer
- Lung Squamous Cell Carcinoma
- Head and Neck Squamous Cell Carcinoma
- Esophageal Squamous Cell Carcinoma
- Solid Tumor
- Cervical Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TER-2013 | Oral Capsules |
| DRUG | Fulvestrant injection | Fulvestrant 500 mg Intramuscular Injection |
Timeline
- Start date
- 2025-09-23
- Primary completion
- 2028-12-30
- Completion
- 2029-02-28
- First posted
- 2025-08-07
- Last updated
- 2026-03-23
Locations
15 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07109726. Inclusion in this directory is not an endorsement.