OncoMatch/Clinical Trials/NCT07454642
AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors
Is NCT07454642 recruiting? Yes, currently enrolling (May 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
Cancer type
Pancreatic Cancer
Gastric Cancer
Cervical Cancer
Biomarker criteria
Required: FAP positive
tumors reported to be FAP positive
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: investigational therapy
Has received prior investigational therapy (defined as a treatment for which there is no Regulatory Authority-approved indication) within 5 half-lives or 28 days (whichever is shorter) of Cycle 1 Day 1
Cannot have received: approved anticancer therapy
Exception: except limited field palliative radiotherapy (requires at least a 7-day washout period)
Has received any approved anticancer therapy, including chemotherapy or hormonal therapy, within 14 days (or 5 half-lives, whichever is shorter) prior to Cycle 1 Day 1
Cannot have received: monoclonal antibody
Subjects who have received a monoclonal antibody within 14 days (or 5 half-lives, whichever is shorter) prior to Cycle 1 Day 1
Cannot have received: radiotherapy
Exception: except limited field palliative radiotherapy (requires at least a 7-day washout period)
Has received radiotherapy within 28 days prior to Cycle 1 Day 1, except for limited field palliative radiotherapy, which requires at least a 7-day washout period
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).
Cardiac function
QTcF ≤ 470 ms demonstrated by at least two single ECGs ≥ 30 minutes apart
Has adequate hematological function...Has adequate liver function...Has adequate renal function...QT interval corrected through use of Fridericia's formula (QTcF) > 470 ms demonstrated by at least two single ECGs ≥ 30 minutes apart.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- NEXT Oncology · Irving, Texas
- NEXT Oncology Virginia · Fairfax, Virginia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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