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

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

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorTerremoto Biosciences Inc.

About this trial

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 criteria

Qualifiers

Metastatic or locally advanced, unresectable disease

No available treatment with curative intent

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Adequate organ function

Disqualifiers

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

Trial design

Treatments tested in this trial

TER-2013
Fulvestrant injection

Treatment groups

205 Participants

are divided into 4 treatment groups

Locations

Puerto Rico

PanOncology Trials00935, San Juan Puerto Rico

United States

Florida

Florida Cancer Specialists - Lake Nona32827, Orlando United States

Massachusetts

Massachusetts General Hospital02144, Boston United States

Minnesota

Mayo Rochester55905, Rochester United States

Sponsors and collaborators

Terremoto Biosciences Inc.

Lead sponsor

Source ClinicalTrials.gov