RecruitingPhase 1/2

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

United States205 participantsStarted 2025-09-23

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. \[For TER-2013 dose escalation\]: Received standard therapies appropriate for their tumor type and stage, unless contraindicated, intolerable, or patient refused
✓. \[For TER-2013 cohort expansion\]: No more than 3 prior lines of treatment in the advanced setting

Exclusion criteria

✕. \[For TER-2013 monotherapy escalation\]: AKT inhibitor
✕. \[For TER-2013 monotherapy expansion\]: AKT/PI3K/PTEN pathway inhibitor
✕. \[For TER-2013 + fulvestrant combination expansion\]: AKT/PI3K/PTEN pathway inhibitor, fulvestrant and other SERDs, mTOR inhibitor; some PIK3CA-altered cohorts allow prior PI3K inhibitor.

What they're measuring

Number of Patients who Experience Dose-Limiting Toxicity

Timeframe: 28 Days

Number of patients who experience a treatment-related adverse event

Timeframe: Up to 2 years

Objective Response Rate as assessed by RECIST v1.1

Timeframe: Up to 2 years

Duration of Response as assessed by RECIST v1.1

Timeframe: Up to 2 years

Trial details

NCT IDNCT07109726

SponsorTerremoto Biosciences Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-12-30

Contact for this trial

Terremoto Biosciences, Inc. Clinical Trials Central Contact

888-682-1551 clinicaltrials@terremotobio.com

View on ClinicalTrials.gov More Breast Cancer trials