A Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Participants With Relapsed and Refractory Multiple Myeloma
Status:
Recruiting
Trial end date:
2025-05-27
Target enrollment:
Participant gender:
Summary
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 in
participants with relapsed and refractory multiple myeloma (MM). The dose escalation part
(Part A) of the study will evaluate the safety and tolerability of escalating doses of
CC-99712, administered intravenously (IV) in monotherapy (Arm 1) or combination (Arm 2), to
determine the maximum tolerated dose (MTD) of CC-99712 guided by a Bayesian logistic
regression model (BLRM). A modified accelerated titration design will also be used for Arm 1
and Arm 2. The MTD may be established separately for CC-99712 administered at Q3W and/ or Q4W
schedules. The expansion part (Part B) will further evaluate the safety and efficacy of
CC-99712 in monotherapy (Arm 1) or combination (Arm 2) administered at or below the MTD in
selected expansion cohorts in order to determine the RP2D. One or more doses or dosing
regimens may be selected for cohort expansion. All participants will be treated until
confirmed disease progression per IMWG criteria, unacceptable toxicity, or
participants//Investigator decision to withdraw.