Phase 12 Study of BIO-106 Alone or With Pembrolizumab for Advanced Solid Tumors and Cancers

What this Trial Is About

Researchers are investigating BIO-106, a new antibody-drug conjugate targeting Trop-2, alone and combined with pembrolizumab, a PD-1 blocking antibody, in patients with advanced solid tumors or cancers that have progressed despite standard treatments or cannot tolerate them. This open-label Phase 12 trial aims to find the best tolerated dose in Phase 1 and evaluate preliminary effectiveness in Phase 2 for patients with significant unmet medical needs. In Phase 1, patients receive increasing doses of BIO-106 alone or with pembrolizumab to determine the maximum tolerated dose or recommended dose for Phase 2. Phase 2 involves dose expansion to assess anti-tumor activity using measures like response rates and survival. Participants receive treatments according to their assigned group, and dosing schedules follow the study design without blinding or placebo. Participants undergo regular monitoring for adverse events, dose-limiting toxicities, and antibody formation against BIO-106. Effectiveness is measured by tumor response, disease control, duration of response, progression-free survival, and overall survival over one to two years. Safety and pharmacokinetics data are collected throughout, with close evaluation of serious events and special interest adverse events. The study expects to last until April 2027.

A Study in Patients With Advanced Cancers