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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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:

‣ \[For TER-2013 dose escalation\]: Received standard therapies appropriate for their tumor type and stage, unless contraindicated, intolerable, or patient refused

⁃ \[For TER-2013 cohort expansion\]: No more than 3 prior lines of treatment in the advanced setting

• 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

Locations
United States
North Carolina
Carolina BioOncology Institute
RECRUITING
Huntersville
Nebraska
Nebraska Cancer Specialists
RECRUITING
Omaha
Texas
NEXT Oncology
RECRUITING
Austin
Virginia
NEXT Oncology
RECRUITING
Fairfax
Contact Information
Primary
Terremoto Biosciences, Inc. Clinical Trials Central Contact
clinicaltrials@terremotobio.com
888-682-1551
Time Frame
Start Date: 2025-09-23
Estimated Completion Date: 2029-02-28
Participants
Target number of participants: 205
Treatments
Experimental: Monotherapy Dose Escalation
Experimental: Combination Therapy Dose Escalation
Dose Escalation of TER-2013 with recommended dose of fulvestrant
Experimental: Monotherapy Dose Expansion
Experimental: Combination Therapy Dose Expansion
Dose Expansion of TER-2013 with recommended dose of fulvestrant
Sponsors
Leads: Terremoto Biosciences Inc.

This content was sourced from clinicaltrials.gov

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