NCT04036461: Phase 1 - A Study of CC-99712, a BCMA Antibody-Drug Conjugate in relapsed MM
Updated: Feb 10
Study CC-99712-MM-001
This 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.
Sponsor
Celgene
Multiple locations
International Study
ClinicalTrials.gov Identifier: NCT04036461
Official title: A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma
First Posted : July 29, 2019
Click here for details on ClinicalTrials.gov
Anti-BCMA Antibody-drug Conjugate CC-99712 (Code C170915)
Anti-BCMA ADC CC-99712
Anti-BCMA Antibody Drug Conjugate CC-99712
Anti-BCMA Antibody-drug Conjugate CC-99712
CC 99712
CC-99712
CC99712
- New York: Roswell Park Cancer Institute Buffalo
- New York: Tisch Cancer Institute Mount Sinai Hospital New York
Locations
United States, California
United States, Florida
United States, New York
United States, Oregon
United States, Texas
United States, Washington
Canada, Alberta
Canada, Ontario
Canada, Quebec
Europe
France
Italy
Spain