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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07454642 on ClinicalTrials.gov