• Recruiting

NCT04036461: Phase 1 - A Study of CC-99712, a BCMA Antibody-Drug Conjugate in relapsed MM

Updated: May 26

Study CC-99712-MM-001

CC-99712

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

 

CC-99712, a BCMA Antibody-Drug Conjugate

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



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