clinical trial · NCT07109726
A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations
Terremoto Biosciences Inc.·phase2·recruiting·n = 205
Breast CancerEndometrial CancerOvarian CancerLung Squamous Cell CarcinomaHead and Neck Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaSolid TumorCervical CancerTER-2013Fulvestrant injection
brief 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.
started
Sep 23, 2025
primary completion
Dec 30, 2028
completion
Feb 28, 2029
last updated
Mar 23, 2026
detailed description
This is a first-in-human clinical trial that will evaluate the safety, tolerability, and pharmacokinetics (PK) of TER-2013 as a monotherapy and in combination with fulvestrant and to determine the maximum tolerated/administered dose and preliminary clinical activity. The study consists of two parts: Part 1-Dose Escalation and Part 2 -Dose Expansion.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol