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New drug targets Hard-to-Treat cancers with genetic weakness

NCT ID NCT07109726

Disease control Sponsor: Terremoto Biosciences Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 3 times

Summary

This study tests a new drug, TER-2013, in people with advanced solid tumors (like breast, ovarian, or lung cancer) that have specific genetic changes in the AKT/PI3K/PTEN pathway. The goal is to see if the drug is safe and can shrink tumors. About 205 participants will receive the drug, and researchers will monitor side effects and how well the cancer responds.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 205 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria * Metastatic or locally advanced, unresectable disease * No available treatment with curative intent * Presence of lesions to be evaluated per RECIST v1.1: a. Dose Escalation: measurable or evaluable disease b. Cohort Expansion: measurable disease * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ function * Advanced solid tumor malignancy harboring an eligible AKT/PI3K/PTEN pathway alteration detected by a sponsor approved test Key Inclusion Criteria for TER-2013 monotherapy arms: * Histologically confirmed diagnosis of: a. \[For TER-2013 dose escalation\]: solid tumor malignancy b. \[For TER-2013 cohort expansion\]: i. Cohort 1: ovarian cancer, cervical cancer, or squamous cell carcinoma of the head and neck, lung, or esophagus ii. Cohort 2: endometrial adenocarcinoma * Prior therapy: 1. \[For TER-2013 dose escalation\]: Received standard therapies appropriate for their tumor type and stage, unless contraindicated, intolerable, or patient refused 2. \[For TER-2013 cohort expansion\]: No more than 3 prior lines of treatment in the advanced setting Key Inclusion Criteria for TER-2013 and fulvestrant combination arms * Histologically confirmed diagnosis of: a. \[For TER-2013 + fulvestrant dose escalation\]: HR+/HER2- advanced unresectable or metastatic breast cancer b. \[For TER-2013 + fulvestrant cohort expansion\]: i. Received treatment with an AI containing regimen (single agent or in combination) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting * Prior Therapy: a. \[For TER-2013 + fulvestrant dose escalation\]: Received treatment with an AI containing regimen (single agent or in combination) b. \[For TER-2013 + fulvestrant cohort expansion\]: i. Received treatment with an AI containing regimen (single agent or in combination) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting Key Exclusion Criteria: * Known EGFR, KRAS, NRAS, HRAS, or BRAF oncogenic-driver co-mutation with PI3K/AKT/PTEN alteration * Clinically significant abnormalities of glucose metabolism * Active brain metastases or carcinomatous meningitis. * History of significant hemoptysis or hemorrhage within 4 weeks prior to first dose of study drug * Malabsorption syndrome, nausea and vomiting uncontrolled by medication, or disease significantly affecting gastrointestinal function likely to interfere with the delivery, absorption, or metabolism of TER-2013 * Prior therapy: 1. \[For TER-2013 monotherapy escalation\]: AKT inhibitor 2. \[For TER-2013 monotherapy expansion\]: AKT/PI3K/PTEN pathway inhibitor 3. \[For TER-2013 + fulvestrant combination expansion\]: AKT/PI3K/PTEN pathway inhibitor, fulvestrant and other SERDs, mTOR inhibitor; some PIK3CA-altered cohorts allow prior PI3K inhibitor. Other protocol-defined Inclusion/Exclusion Criteria apply

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm cervical cancer endometrial cancer endometrium adenocarcinoma endometrium neoplasm esophageal squamous cell carcinoma head and neck squamous cell carcinoma hormone receptor-positive breast cancer neoplasm ovarian cancer Squamous Cell Carcinoma of Head and Neck squamous cell lung carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Cervical cancer Endometrial cancer Esophageal squamous cell carcinoma Head and neck squamous cell carcinoma Lung squamous cell carcinoma Ovarian cancer Solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    18 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Carolina BioOncology Institute

    WITHDRAWN

    Huntersville, North Carolina, 28078, United States

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • City of Hope, Chicago

    RECRUITING

    Zion, Illinois, 60099, United States

  • City of Hope, Irvine

    RECRUITING

    Irvine, California, 92618, United States

  • Florida Cancer Specialists - Lake Nona

    RECRUITING

    Orlando, Florida, 32827, United States

  • Froedtert & MCW Cancer Center

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02144, United States

  • Mayo Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

    Contact Email: •••••@•••••

  • NEXT Oncology

    ACTIVE_NOT_RECRUITING

    Austin, Texas, 78229, United States

  • NEXT Oncology

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Nebraska Cancer Specialists

    RECRUITING

    Omaha, Nebraska, 68130, United States

  • PanOncology Trials

    RECRUITING

    San Juan, 00935, Puerto Rico

    Contact Email: •••••@•••••

  • START Center for Cancer Research

    RECRUITING

    San Antonio, Texas, 78229, United States

  • START Center for Cancer Research

    RECRUITING

    West Valley City, Utah, 84119, United States

  • START Lisboa

    RECRUITING

    Lisbon, Portugal, 1649-035, Portugal

    Contact Email: •••••@•••••

  • START Madrid, Fundacion Jimenez Diaz

    RECRUITING

    Madrid, Spain, 28040, Spain

    Contact Email: •••••@•••••

  • Sarah Cannon Nashville

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • UH Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Washington Univ. School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.