Phase 1 Study of AVA6103, a New FAP-Activated Drug Given by IV, in Adults With Locally Advanced or Metastatic Selected Solid Tumors

What this Trial Is About

Researchers are investigating AVA6103, a novel FAP-activated Exatecan drug, in patients with locally advanced or metastatic solid tumors that are likely positive for fibroblast activation protein FAP. This first-in-human, Phase 1, open-label, multicenter study aims to assess the safety, tolerability, and dosing of AVA6103 in patients who have cancers such as cervical, vulvar, small cell lung, gastric, pancreatic, colorectal, and hormone receptor positive breast carcinoma. The study includes a dose escalation phase followed by a dose expansion phase to evaluate initial therapeutic activity and pharmacokinetics. The study has two parts Phase 1a dose escalation and Phase 1b dose expansion. In Phase 1a, patients receive escalating doses of AVA6103 intravenously either every 3 weeks Q3W or every 2 weeks Q2W to find the maximum tolerated dose or recommended phase 2 dose. In Phase 1b, patients receive AVA6103 at the recommended dose until disease progression, unacceptable side effects, withdrawal, or death. Treatment continues under close monitoring in both phases. Participants will undergo regular assessments including monitoring of adverse events, dose-limiting toxicities, and pharmacokinetic blood sampling. Researchers will track tumor response, duration of response, progression-free survival, overall survival, and drug concentration in the blood. Safety is followed up to 30 days after the last dose, with overall survival monitored up to one year. Participants are expected to comply with study procedures, including optional tumor biopsies and scheduled clinic visits for evaluations throughout the study period.

AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors