AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors
NCT07454642 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144
Last updated 2026-05-15
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.
Conditions
- Vulvar Adenocarcinoma
- PDAC - Pancreatic Ductal Adenocarcinoma
- Gastric Adenocarcinoma
- GEJ Adenocarcinoma
- Cervical Adenocarcinoma
- Cervical Adenosquamous Carcinoma
- Small Cell Carcinoma of Lung
Interventions
- DRUG
-
AVA6103
AVA6103 is a FAP-activated Exatecan
Sponsors & Collaborators
-
Avacta Life Sciences Ltd
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-31
- Primary Completion
- 2029-01-31
- Completion
- 2030-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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