Phase 1 Study of STRO-006 in Adults With Refractory Solid Tumors That Are Recurrent or Metastatic

Summary

This study is a first-in-human (FIH) Phase 1 open-label, multicenter study including three parts: * Part 1A is a dose escalation of STRO-006 monotherapy in selected tumor types reported to commonly express ITGB6. Part 1A will determine the safety, tolerability, pharmacokinetics (PK), and preliminary anti-tumor activity of STRO-006. * Part 1B is a dose expansion in one or more indications, as determined by the Sponsor, to further evaluate a STRO-006 monotherapy dose, examine anti-tumor activity, and determine the recommended Phase 2 dose (RP2D) of STRO-006 monotherapy. * Part 1C is a combination dose escalation to determine safety, tolerability, PK, and preliminary anti-tumor activity of STRO-006 combined with pembrolizumab.

Timeline

Start

2026-09-14

Primary completion

2028-02

Completion

2028-12

Drugs

Indications