Crossbow Therapeutics, Inc.
This is a Phase 1, open-label, dose-escalation study of CBX-663 in participants with R/R AML, MDS or CMML (Cohort A), advanced solid tumors (Cohort B), or recurrent or progressive GBM (Cohort C) (collectively called 'indication cohorts'). Participants aged ≥18 years are planned to be enrolled. CBX-663 will initially be investigated on a fixed dosing schedule. CBX-663 will be administered intravenously (IV) on Cycle 1 Day 1 (C1D1) and then once weekly (QW) in 21-day cycles. Participants will continue treatment with CBX-663 until unacceptable toxicity, progressive disease, withdrawal of consent, or lack of clinical benefit.
Inclusion Criteria: Cohort A (R/R AML, MDS or CMML) Specific Inclusion Criteria: 1. R/R AML, as defined by standardized criteria (e.g., European Leukemia Net criteria (Dohner, 2022) (Arber, 2022); after standard of care therapy. Participants with persistent leukemia after initial therapy or with recurrence of leukemia at any time after achieving a response during or after the course of treatment (including HSCT) are eligible. Participants must have bone marrow blasts ≥5%. 2. R/R MDS as per WHO 2022. Participants must have peripheral or bone marrow blasts \<20%, and must have exhausted locall…
Intravenous (I.V.) CBX-663
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