A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours

Complete Title: A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6000, a Novel FAP-activated Doxorubicin Administered Intravenously in Patients with Locally Advanced or Metastatic Selected Solid Tumours

Trial Phase: I

Investigator: Lee Cranmer

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.

Keywords:

Bladder Cancer
Breast Cancer
Head and Neck Cancer
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Sarcoma
Lung Carcinoma, Non-Small-Cell (NSCLC)
Colorectal Neoplasms
Biliary Tract Neoplasms
Neoplasms, Soft Tissue

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