A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6000, a Novel FAP-activated Doxorubicin Administered Intravenously in Patients With Locally Advanced or Metastatic Selected Solid Tumours

What this Trial Is About

Researchers are evaluating AVA6000, a novel FAP-activated doxorubicin drug, in patients with locally advanced or metastatic solid tumors likely positive for fibroblast activation protein (FAP). This first-in-human, open-label Phase 1 study aims to assess the safety, tolerability, and appropriate dosing of AVA6000 given intravenously. The study includes patients with specific tumor types such as salivary gland, urothelial, ovarian, breast carcinoma, and soft tissue sarcoma, focusing on those who have relapsed, progressed, or are not suitable for standard treatments. The study has two parts: Phase 1a dose escalation and Phase 1b dose expansion. In Phase 1a, AVA6000 is given in two schedules—once every 21 days or once every 14 days—with increasing doses to find the maximum tolerated dose or recommended dose. In Phase 1b, patients receive AVA6000 at the recommended dose identified from Phase 1a. Treatment continues until disease progression, unacceptable side effects, withdrawal, reaching maximum lifetime exposure to related drugs, or death. Participants will undergo safety monitoring including assessments of dose-limiting toxicities, adverse events, lab tests, vital signs, and heart health, from the start of treatment until 30 days after the last dose. Pharmacokinetics of AVA6000 and doxorubicin will be studied in the early cycles. Researchers will monitor tumor response, progression-free survival, and overall survival up to one year. Participants need to provide tissue samples and attend follow-up visits as part of the study requirements.

A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours