Life sciences · Phase 1 Trial
ClinicalTrials.gov · October 5, 2026
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Phase 1 Trial.
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Registry record from ClinicalTrials.gov (NCT07454642). This is a study registration, not published results. Lead sponsor: Avacta Life Sciences Ltd. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 174 participants (ESTIMATED). Conditions: Vulvar Adenocarcinoma, PDAC - Pancreatic Ductal Adenocarcinoma, Gastric Adenocarcinoma, GEJ Adenocarcinoma, Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Small Cell Carcinoma of Lung, Colorectal Cancer, Hormone Receptor Positive Breast Carcinoma. Interventions: DRUG: AVA6103. Primary outcome measures: Adverse events (AEs) , From Day 1 until up to 30 days after last dose of study drug.; Dose-limiting toxicities (DLTs) , 21 days from the first dose for the every 3 week dosing schedule and 28 days from the first dose for the every 2 week schedule. Brief summary: This is a first-in-human (FIH), Phase 1 open-label, multicenter dose escalation study investigating AVA6103 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumors that are likely to be FAP positive. The study consists of an initial Phase 1a dose escalation portion and a subsequent Phase 1b dose expansion portion upon completion of the dose escalation portion.