Study CC-99712-MM-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part B), First-in-Human (FIH) clinical study of CC-99712 in monotherapy or combination with BMS-986405 in participants with relapsed and refractory multiple myeloma (MM).
This trial is currently open and accepting patients.
Dose Escalation (Part A)
The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of CC-99712, administered intravenously (IV), to determine the maximum tolerated dose (MTD) and non-tolerated dose (NTD) of CC-99712 using a modified accelerated titration design and Bayesian methodology. The maximum tolerated dose and non-tolerated dose may be established separately for CC-99712 administered at Q3W and/ or Q4W schedules.
Dose Expansion (Part B)
The expansion part (Part B) will further evaluate the safety and efficacy of CC-99712 administered at or below the maximum tolerated dose in selected expansion cohorts in order to determine the recommended phase 2 dose (RP2D). One or more dosing regimens may be selected for cohort expansion. All subjects will be treated until confirmed disease progression per IMWG criteria, unacceptable toxicity, or subject/Investigator decision to withdraw.
The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.
Other protocol-defined inclusion/exclusion criteria apply
Enrollment: 160 patients (estimated)View More
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