RECRUITING

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

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Conditions

Breast CancerEndometrial CancerOvarian CancerLung Squamous Cell CarcinomaHead and Neck Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaSolid TumorCervical CancerAKT/PI3K/PTEN AlterationsAdvanced Solid TumorsHR+/HER2-

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08
Study Completion:2029-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07109726

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Known EGFR, KRAS, NRAS, HRAS, or BRAF oncogenic-driver co-mutation with PI3K/AKT/PTEN alteration
  2. * Clinically significant abnormalities of glucose metabolism
  3. * Active brain metastases or carcinomatous meningitis.
  4. * History of significant hemoptysis or hemorrhage within 4 weeks prior to first dose of study drug
  5. * 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
  6. * Prior therapy:
  7. 1. \[For TER-2013 monotherapy escalation\]: AKT inhibitor
  8. 2. \[For TER-2013 monotherapy expansion\]: AKT/PI3K/PTEN pathway inhibitor
  9. 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.

Contacts and Locations

Study Contact

Terremoto Biosciences, Inc. Clinical Trials Central Contact
CONTACT
888-682-1551
clinicaltrials@terremotobio.com

Study Locations (Sites)

Carolina BioOncology Institute
Huntersville, North Carolina, 28078
United States

Collaborators and Investigators

Sponsor: Terremoto Biosciences Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08
Study Completion Date2029-02-28

Study Record Updates

Study Start Date2025-08
Study Completion Date2029-02-28

Terms related to this study

Keywords Provided by Researchers

  • AKT/PI3K/PTEN Alterations
  • Breast Cancer
  • Advanced Solid Tumors
  • HR+/HER2-

Additional Relevant MeSH Terms

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