NCT07454642

AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors

A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6103, a Novel FAP-activated Exatecan Administered Intravenously in Subjects With Locally Advanced or Metastatic Selected Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Avacta Life Sciences Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Phase 1a (Dose Escalation): The dose-escalation portion is designed to evaluate the safety, tolerability and MTD and/or RP2D of AVA6103, administered as monotherapy in two schedules: Day 1 of a 21-day cycle (Q3W schedule) and Day 1 of a 14-day cycle (Q2W schedule). Phase 1b (Dose Expansion): The dose-expansion arm is based on review of data in the dose escalation phase, with AVA6103 administered at the RP2D.

Conditions

• Vulvar Adenocarcinoma
• PDAC - Pancreatic Ductal Adenocarcinoma
• Gastric Adenocarcinoma
• GEJ Adenocarcinoma
• Cervical Adenocarcinoma
• Cervical Adenosquamous Carcinoma
• Small Cell Carcinoma of Lung

Interventions

Type	Name	Description
DRUG	AVA6103	AVA6103 is a FAP-activated Exatecan

Timeline

• Start date: 2026-03-01
• Primary completion: 2029-01-01
• Completion: 2030-06-01
• First posted: 2026-03-06
• Last updated: 2026-03-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study