OncoMatch/Clinical Trials/NCT07454642
AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors
Official title: 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
Is NCT07454642 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies AVA6103 for vulvar adenocarcinoma.
Treatment: AVA6103 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Pancreatic Cancer
Gastric Cancer
Cervical Cancer
Colorectal Cancer
Breast Carcinoma
Biomarker criteria
Required: FAP expression (testing required; no eligibility threshold specified)
tumors reported to be FAP positive
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
Absolute neutrophil count of ≥1.5 × 10^9 cells/L (≥1.0 × 10^9 cells/L for benign ethnic neutropenia); Hemoglobin ≥9.0 g/dL; Platelet count of ≥100,000/µL; INR and aPTT ≤1.5 × ULN except for subjects on direct acting anticoagulation
Kidney function
creatinine clearance ≥ 60 mL/min by the Cockcroft-Gault equation
Liver function
Total bilirubin 1.5 × ULN (except for subjects with documented Gilbert's Syndrome or liver metastases who must have a total bilirubin <3 × ULN). AST and ALT ≤2.5 × ULN (in subjects with liver metastases, <5 × ULN is allowed).
Has adequate hematological function...Has adequate liver function...Has adequate renal function as defined by creatinine clearance ≥ 60 mL/min by the Cockcroft-Gault equation.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Honor Health Research Institute · Scottsdale, Arizona
- Florida Cancer Specialists and Research Institute · Sarasota, Florida
- The University of Chicago · Chicago, Illinois
- START Midwest · Grand Rapids, Michigan
- Memorial Sloan Kettering Cancer Center · New York, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07454642 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require FAP?
Yes, FAP expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages