NCT04969835 A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours
| NCT ID | NCT04969835 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Avacta Life Sciences Ltd |
| Condition | Salivary Gland Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 158 participants |
| Start Date | 2021-07-16 |
| Primary Completion | 2026-03-15 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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 Criteria
Inclusion Criteria: 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