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.
This study is a first-in-human (FIH), Phase 1, open-label, multicentre, dose-escalation study
investigating AVA6000 monotherapy administered intravenously (IV) in patients with locally
advanced (unresectable) and/or metastatic solid tumours.
The study will be conducted in two parts: Phase 1a (Dose Escalation) and Phase 1b (Dose
Phase 1a (Dose Escalation): The dose-escalation phase is designed to evaluate the safety,
tolerability and MTD and/or RP2D of AVA6000, administered as monotherapy
Phase 1b (Dose Expansion): The dose-expansion phase will comprise 1 to 3 expansion arms in
specific tumour types to evaluate the safety and tolerability of AVA6000 at the MTD or RP2D
when administered as monotherapy. The tumour types to be explored in Phase 1b, will be
determined based on evaluation of the Phase 1a data and the protocol will be amended
Non-Small Cell Lung Cancer,
urinary tract neoplasm,
Connective and Soft Tissue Neoplasm,
Neoplasm of unspecified nature of digestive system,
head and neck cancer,
Breast Cancer Diagnosis,
cancer of the ovary,
carcinoma of the bladder,
soft tissue sarcomas,
cancer of the head and neck,
cancer of the pancreas,
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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