Study of AVA6103 for Advanced Solid Tumors

This study is testing a new drug called AVA6103 in people with certain advanced solid tumors, including vulvar, pancreatic, stomach, GEJ (where the esophagus meets the stomach), and cervical cancers. AVA6103 is designed to be activated by a protein called FAP, which is often found in these types of tumors. The main goals are to see how safe AVA6103 is, what side effects it causes, and to find the best dose. This is a "first-in-human" study, meaning it's one of the first times this drug is being given to people. You might be able to join if you have one of these cancers that is locally advanced (cannot be removed by surgery) or has spread, and your tumor is believed to be FAP positive.

Study design
This is an open-label, multi-center Phase 1 study, meaning both you and your doctors will know you are receiving AVA6103. It plans to enroll 174 participants and has two parts: a dose escalation phase to find the right dose, and a dose expansion phase to further test that dose.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from the first day of treatment until up to 30 days after your last dose of AVA6103.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07454642

AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Avacta Life Sciences Ltd
~174 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:AVA6103

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse events (AEs)
Measured over From Day 1 until up to 30 days after last dose of study drug.
+1 more outcome measured
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
3 sites across 3 states
Michigan1
Texas1
Virginia1

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  • Adverse events (AEs)From Day 1 until up to 30 days after last dose of study drug.

    Incidence and severity of treatment-emergent (TE) and treatment-related adverse events (TRAEs) and Serious Adverse Events (SAEs).

  • 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

    Incidence and nature of DLTs