RecruitingPhase 1Phase 2NCT07109726

A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations


Sponsor

Terremoto Biosciences Inc.

Enrollment

205 participants

Start Date

Sep 23, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called TER-2013 for people with advanced solid tumors that have specific genetic changes in a pathway called AKT/PI3K/PTEN. This pathway, when altered, can drive cancer growth. The drug may be given alone or combined with another hormone-blocking drug (fulvestrant) for certain breast cancers. **You may be eligible if...** - You have advanced or metastatic solid tumor cancer that cannot be cured with current treatments - Your tumor has a confirmed AKT, PI3K, or PTEN genetic change - You are in reasonably good physical condition (able to carry out normal daily activities) - Depending on the group: you have ovarian, cervical, head and neck, lung, esophageal, or endometrial cancer (monotherapy), or hormone receptor-positive, HER2-negative breast cancer (combination group) - You have received prior standard treatments **You may NOT be eligible if...** - Your tumor has certain other driver mutations (EGFR, KRAS, BRAF, etc.) alongside the PI3K/AKT change - You have active brain metastases - You have uncontrolled blood sugar problems - You have had an AKT or PI3K inhibitor before (for expansion cohorts) - You have severe gut problems that would prevent absorbing the drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTER-2013

Oral Capsules

DRUGFulvestrant injection

Fulvestrant 500 mg Intramuscular Injection


Locations(15)

Florida Cancer Specialists - Lake Nona

Orlando, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Mayo Rochester

Rochester, Minnesota, United States

Washington Univ. School of Medicine

St Louis, Missouri, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

Carolina BioOncology Institute

Huntersville, North Carolina, United States

UH Cleveland Medical Center

Cleveland, Ohio, United States

Sarah Cannon Nashville

Nashville, Tennessee, United States

NEXT Oncology

Austin, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

START Center for Cancer Research

San Antonio, Texas, United States

START Center for Cancer Research

West Valley City, Utah, United States

NEXT Oncology

Fairfax, Virginia, United States

Froedtert & MCW Cancer Center

Milwaukee, Wisconsin, United States

PanOncology Trials

San Juan, Puerto Rico

View Full Details on ClinicalTrials.gov

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NCT07109726


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