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Phase 1/2 Study of TER-2013 for Solid Tumors with AKT/PI3K/PTEN Alterations

This study is testing a new drug called TER-2013, given as oral capsules, either alone or with fulvestrant injection, for people with advanced solid tumors. These tumors include breast, endometrial, ovarian, lung squamous cell, and head and neck squamous cell cancers that have specific changes in their AKT/PI3K/PTEN pathways. The study aims to find out how safe TER-2013 is, what side effects it might cause, and if it can shrink tumors. To join, you must have advanced cancer that can't be cured with standard treatments, and your tumor must have certain measurable areas. The study is looking for about 205 participants, but its current recruitment status is unclear.

Study design
This is a Phase 1/2, open-label study, meaning both you and your doctors will know which treatment you are receiving. It will involve about 205 participants and is designed to evaluate TER-2013 as a single drug and in combination with fulvestrant.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects for up to 2 years and tumor response for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07109726

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Terremoto Biosciences Inc.
~205 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:TER-2013Fulvestrant injection

At a glance

Recruiting sites
18 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Patients who Experience Dose-Limiting Toxicity
Measured over 28 Days
+3 more outcomes measured

Conditions

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

Explore related trials

Breast CarcinomaCervical CarcinomaEndometrial CarcinomaEsophageal Squamous Cell CarcinomaHead and Neck Squamous Cell CarcinomaLung Squamous Cell CarcinomaMalignant Ovarian NeoplasmSolid Neoplasm

Where it's being run

18 sites across 15 states
Texas3
California2
Florida1
Illinois1
Massachusetts1
Minnesota1
Missouri1
Nebraska1

Who to contact

Terremoto Biosciences, Inc. Clinical Trials Central Contact
[email protected]
888-682-1551
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Metastatic or locally advanced, unresectable disease
No available treatment with curative intent
Presence of lesions to be evaluated per RECIST v1.1:
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
Histologically confirmed diagnosis of:
Prior therapy:
Histologically confirmed diagnosis of:
Prior Therapy:

Exclusion

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:

What this trial measures

  • Number of Patients who Experience Dose-Limiting Toxicity28 Days
  • Number of patients who experience a treatment-related adverse eventUp to 2 years
  • Objective Response Rate as assessed by RECIST v1.1Up to 2 years
  • Duration of Response as assessed by RECIST v1.1Up to 2 years