Crescent Biopharma, Inc.
The purpose of this study is to determine the safety and tolerability of monotherapy CR-002 and to identify the MTD and/or optimal biologic dose and RP2D(s) in participants with locally advanced or metastatic solid tumors.
The study will initially comprise 2 parts: dose escalation (Part 1) and backfill (Part 2). Population-defined dose optimization (Part 3) and expansion (Part 4) cohorts may be added based on emerging data. Part 1: The study will follow a stepwise approach, beginning with a typical dose escalation in participants with selected indications of advanced solid tumors. Part 2: Additional participants will enroll in the backfill part at select dose levels that have been previously cleared for safety by the safety review committee. All participants will undergo a screening period, a treatment period…
Inclusion Criteria: * Life expectancy ≥ 3 months * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1 * Adequate organ function and hematologic reserve based on laboratory parameters * Have measurable disease defined by RECIST v1.1 * Willingness to provide recent archival tumor tissue sample or willingness to undergo biopsy * Tumor indication specific inclusion criteria: * Is progressing from, intolerant to, or ineligible for (due to unavailability or contraindication) local standard of care therapies and have one of the following locally advanced or metastatic tumor…
Intravenous Infusion