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NCT07109726 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Breast Cancer and Ovarian Cancer, sponsored by Terremoto Biosciences.

Recruiting
Registry status
Phase 1
Development phase
205
Enrollment target
15
Study locations

NCT07109726 is a Phase 1 study of Breast Cancer and Ovarian Cancer that is actively recruiting participants, run by Terremoto Biosciences. The registered enrollment target is 205 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (93% lower). The trial reports 15 study locations across 13 states.

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The verdict

NCT07109726, a Phase 1 study of Breast Cancer and Ovarian Cancer, is actively recruiting participants, sponsored by Terremoto Biosciences.

RECRUITING
Registry status
Phase 1
Development phase
205 participants
Enrollment target
15
Study locations

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.

Conditions Studied

Breast Cancer Ovarian Cancer Solid Tumor Endometrial Cancer Cervical Cancer Head and Neck Squamous Cell Carcinoma Esophageal Squamous Cell Carcinoma Lung Squamous Cell Carcinoma

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, categorized as Phase 1. The registered enrollment target is 205 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (93% lower). The listed sponsor is Terremoto Biosciences, which has 2 total studies on file at ClinicalTrials.gov.

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.

NCT07109726 reports 15 study locations spanning 13 distinct geographic areas - top geographies include Texas, Florida, Massachusetts.

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.

What interventions are being tested in trial NCT07109726?

The interventions under investigation include: TER-2013 (DRUG), Fulvestrant injection (DRUG).

Who is sponsoring clinical trial NCT07109726?

This trial is sponsored by Terremoto Biosciences, which has 2 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.