An Open Label, Phase 1/2 Study Evaluating Immunomodulatory AVM0703 in Patients With Lymphoid Malignancies (OPAL Study)
AVM Biotechnology Inc
Summary
This is an open-label, Phase 1/2 study designed to characterize the safety, tolerability, Pharmacokinetics(PK), and preliminary antitumor activity of AVM0703 administered as a single intravenous (IV) infusion to patients with lymphoid malignancies.
Description
Phase 2 For Phase 2, one or more patient cohort(s) will receive repeat RP2D infusions in 21 day intervals until intolerance, unacceptable toxicity or disease progression, to determine the number of repeat infusions that are safe, effective and tolerable in this patient population. PK assessments will be made at sites participating in both Phase 1 and Phase 2 after each repeat infusion for the first 6 patients enrolled into each repeat dosing cohort. Full PK assessments will be made as per Phase 1 after the 1st (first) and 6th (sixth) repeat infusions, while for the second to fifth doses (2nd t…