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A Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Participants With Relapsed and Refractory Multiple Myeloma

  • Status Recruiting
    Recruiting
  • Condition Multiple Myeloma
    Multiple Myeloma
  • Phase Phase 1
    Phase 1
INTERVENTION

Drug: CC-99712, Drug: BMS-986405

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: CC-99712, Drug: BMS-986405

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

University of California San Diego Moores Cancer Center, La Jolla, California, United States

Brief 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.