OncoMatch/Clinical Trials/NCT04969835
A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours
Is NCT04969835 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies AVA6000 for salivary gland tumor.
Treatment: AVA6000 — This is a first-in-human (FIH), Phase 1 open-label, multicentre dose escalation study investigating AVA6000 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumours 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
Urothelial Carcinoma
Ovarian Cancer
Breast Carcinoma
Sarcoma
Biomarker criteria
Required: FAP positive
tumours reported to be FAP positive with histological or cytological confirmation
Required: BRCA1 wild-type
Patients must be BRCA wild-type
Required: BRCA2 wild-type
Patients must be BRCA wild-type
Disease stage
Required: Stage LOCALLY ADVANCED (UNRESECTABLE), IV
Grade: high grade (soft tissue sarcoma)
locally advanced (unresectable) and/or metastatic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard of care
relapsed or progressed on SoC treatment or are intolerant or nonamenable to SoC treatment
Cannot have received: trastuzumab (trastuzumab)
Has received trastuzumab within 7 months of the planned Cycle 1 Day 1 AVA6000 infusion
Cannot have received: anthracycline (doxorubicin)
Has received a prior total cumulative anthracycline dose of ≥ 350 mg/m2 doxorubicin (or equivalent anthracycline dose)
Lab requirements
Blood counts
ANC ≥1.5 × 10^9/L; Hgb ≥9.0 g/dL; platelets ≥75,000/µL; INR/aPTT ≤1.5x ULN
Kidney function
creatinine clearance ≥50 mL/min by Cockcroft-Gault or normal plasmatic creatinine despite CrCl <50 mL/min
Liver function
Total bilirubin below ULN (except Gilbert's Syndrome <3x ULN); AST/ALT ≤2.5x ULN (≤5x ULN with liver mets); ALP <5x ULN with liver/bone mets or <2x ULN without mets
Cardiac function
LVEF ≥55% or institutional lower limit; no NYHA >II CHF; no serious arrhythmia requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia); no MI within 6 months; no uncontrolled cardiovascular disease; no high-sensitivity troponin above normal at baseline
Has adequate haematological function ... Has adequate liver function ... Has adequate renal function ... LVEF <55% or the low limit of institutional normal limit (whichever is lower) by echocardiogram (ECHO), serious cardiac arrhythmia requiring treatment ... history of myocardial infarction within 6 months prior to Cycle 1 Day 1, or history of uncontrolled cardiovascular disease or high-sensitivity troponin above normal at baseline (T or I)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Cancer Center · New York, New York
- University of Texas MD Anderson Cancer Center · Houston, Texas
- Fred Hutchinson Cancer Center · Seattle, Washington
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04969835 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior trastuzumab, anthracycline disqualifies patients from enrollment.
Does this trial require FAP?
Yes, FAP positive is a required biomarker for enrollment.
Does this trial require BRCA1?
Yes, BRCA1 wild-type is a required biomarker for enrollment.
Does this trial require BRCA2?
Yes, BRCA2 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage LOCALLY ADVANCED (UNRESECTABLE) or IV is required.
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