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RECRUITING Phase 1

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

NCT07109726 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG TER-2013
  • DRUG Fulvestrant injection

Study Locations (15)

Texas

  • NEXT Oncology — Austin
  • MD Anderson Cancer Center — Houston
  • START Center for Cancer Research — San Antonio

Florida

  • Florida Cancer Specialists - Lake Nona — Orlando

Massachusetts

  • Massachusetts General Hospital — Boston

Minnesota

  • Mayo Rochester — Rochester

Missouri

  • Washington Univ. School of Medicine — St Louis

Nebraska

  • Nebraska Cancer Specialists — Omaha

North Carolina

  • Carolina BioOncology Institute — Huntersville

Ohio

  • UH Cleveland Medical Center — Cleveland

Trial Details

FieldValue
Enrollment Target 205 participants
Start Date 2025-09-23
Est. Completion 2029-02-28
Phase Phase 1

Sponsor

Terremoto Biosciences

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07109726

The ClinicalTrials.gov registry entry for NCT07109726 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 205 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Terremoto Biosciences, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 8 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions — of which TER-2013 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07109726 reports 15 study locations spanning 13 distinct geographic areas — top geographies include Texas, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07109726 about?

NCT07109726 is a clinical study titled "A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations". 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.

What is the current status of trial NCT07109726?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 205 participants. The study started on 2025-09-23. Estimated completion is 2029-02-28.

What conditions does trial NCT07109726 study?

This clinical trial studies the following conditions: Breast Cancer, Ovarian Cancer, Solid Tumor, Endometrial Cancer, Cervical Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07109726?

The interventions under investigation include: TER-2013 (DRUG), Fulvestrant injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07109726?

This trial is sponsored by Terremoto Biosciences, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07109726 being conducted?

This trial has 15 study locations across Florida, Massachusetts, Minnesota, Missouri, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial