ClinicaliQ Trial Snapshot
- A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours — Recruiting • Phase I • Oncology • NCT04969835.
- What is being tested: AVA6000 is a novel intravenous monotherapy undergoing first-in-human Phase 1 evaluation to establish safety, pharmacokinetics, and early efficacy in patients with FAP-positive solid tumours using a dose escalation design.
- Patient eligibility overview: The trial enrolls patients with locally advanced (unresectable) or metastatic solid tumours predicted to express fibroblast activation protein (FAP), with eligibility determined through standard oncology criteria and FAP-positive tumour status.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : 1. The patient has been fully informed about the study and has signed the Informed Consent Form. 2. Male or female patients, ≥ 18 years of age. 3. a) Phase 1a: patients with tumours reported to be FAP positive with histological or cytological confirmation of a locally advanced (unresectable) and/or metastatic: a. salivary gland, urothelial, ovarian, or breast carcinoma, who have either relapsed or progressed on SoC treatment or are intolerant or nonamenable to SoC treatment; OR b. soft-tissue sarcoma who: i. is treatment naïve in the locally advanced (unresectable) or metastatic setting and anthracycline naïve (any setting) and would otherwise be a candidate for doxorubicin hydrochloride treatment; OR ii. has received a total doxorubicin dose of < 150mg/m2 (any setting (< 2 cycles of 75 mg/m2 Q21 days) and has discontinued due to intolerance or toxicity related to doxorubicin b) Phase 1b: patients with histological or cytological confirmation of a locally advanced (unresectable) and/or metastatic tumour of one of the following types: 1. High grade soft tissue sarcoma: histologically proven locally advanced or metastatic, unresectable progressive or recurrent DDLS or UPS who have received 0 or 1 prior lines of therapy in the locally advanced or metastatic…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.