RecruitingPhase 1NCT07454642

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


Sponsor

Avacta Life Sciences Ltd

Enrollment

144 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new experimental drug called AVA6103 in patients with certain advanced solid tumors that express a protein called FAP (fibroblast activation protein) on their surface. The cancers being studied include cervical/vulvar cancer, small cell lung cancer, stomach/esophageal junction cancer, and pancreatic cancer that have progressed after standard treatments. **You may be eligible if...** - You are 18 or older with a confirmed advanced or metastatic form of one of the qualifying cancers - Your cancer has already received all available standard treatments, or you cannot receive or do not want those treatments - You are in good physical condition (ECOG 0–1) - Your organ function (blood counts, liver, kidneys) is adequate **You may NOT be eligible if...** - You have active or untreated brain metastases - You have another active cancer (other than minor skin cancers or early prostate cancer) - You have active HIV (unless well-controlled), active hepatitis B or C, or a recent severe infection - You have had major surgery within 21 days before the study - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAVA6103

AVA6103 is a FAP-activated Exatecan


Locations(2)

NEXT Oncology

Irving, Texas, United States

NEXT Oncology Virginia

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT07454642


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