A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations
NCT07109726 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 205
Last updated 2026-05-22
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.
Conditions
Interventions
- DRUG
-
TER-2013
Oral Capsules
- DRUG
-
Fulvestrant injection
Fulvestrant 500 mg Intramuscular Injection
Sponsors & Collaborators
-
Terremoto Biosciences Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-23
- Primary Completion
- 2028-12-30
- Completion
- 2029-02-28
- FDA Drug
- Yes
Countries
- United States
- Puerto Rico
Study Locations
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