Phase 12 Study of TER-2013 Alone or with Fulvestrant in Adults with Advanced Solid Tumors Having AKTPI3KPTEN Pathway Changes

What this Trial Is About

Researchers are evaluating TER-2013 in a Phase 12 open-label study involving patients with advanced solid tumors that have specific alterations in the AKTPI3KPTEN pathway. This first-in-human trial aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effects of TER-2013 both alone and combined with fulvestrant. The study is conducted across multiple centers and includes patients with cancers such as breast, endometrial, ovarian, lung squamous cell, head and neck squamous cell, esophageal squamous cell, cervical cancer, and other solid tumors. The trial has two main parts Dose Escalation and Dose Expansion. Participants receive TER-2013 oral capsules either by itself or alongside fulvestrant, an injection given intramuscularly at 500 mg. The Dose Escalation part determines the maximum tolerated dose and assesses safety, while the Dose Expansion evaluates preliminary clinical activity at the recommended dose. Treatment schedules include administration of TER-2013 with recommended doses of fulvestrant where applicable. Participants undergo regular evaluations for safety and treatment effects up to two years. Researchers monitor dose-limiting toxicities within 28 days, treatment-related adverse events, objective response rates, and duration of response according to RECIST criteria. Pharmacokinetic parameters such as drug concentration over time and pharmacodynamic markers in tissue and blood are also assessed. The study involves ongoing safety monitoring and follows participants to gather comprehensive data on TER-2013s effects.

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