A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours
Status:
Recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
Summary
This open-label, First-into-Human (FIH) study will evaluate the safety, tolerability,
pharmacokinetics (PK) and early efficacy of AVA6000, a FAP-activated pro-drug of doxorubicin,
in patients with locally advanced and/or metastatic solid tumours. In Phase Ia, using a 3+3
design, escalating doses of AVA6000 will be administered to patients with a range of solid
tumour types to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose
(RP2D). In Phase 1b, the selected RP2D dose will be assessed in one to three tumour types.