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

Official Title

A Phase 1, Multicentre, Open-label, Dose Finding Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma

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 subjects 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), 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 MTD and NTD 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 administered at or below the MTD in selected expansion cohorts in order to determine the 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.

Trial Description

Primary Outcome:

  • Adverse Events (AEs)
  • Non-Tolerated Dose (NTD) in subjects with relapsed and refractory MM
  • Maximum Tolerated Dose (MTD) in subjects with relapsed and refractory MM
  • Dose Limiting Toxicity (DLT) in subjects with relapsed and refractory MM
Secondary Outcome:
  • Overall Response Rate (ORR)
  • Time to Response
  • Duration of Response
  • Progression-free Survival (PFS)
  • Overall Survival (OS)
  • Pharmacokinetics- Cmax
  • Pharmacokinetics- Cmin
  • Pharmacokinetics- AUC
  • Pharmacokinetics- tmax
  • Pharmacokinetics- t1/2
  • Pharmacokinetics- CL
  • Pharmacokinetics- Vss
  • Presence and frequency of ADA using a validated bridging immunoassay with electrochemiluminescence detection

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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