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

Phase 1

Active, not recruiting

• Conditions: Multiple Myeloma
• Interventions: Drug: CC-99712; Drug: BMS-986405

• Registration Number: NCT04036461
• Lead Sponsor: Celgene

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 with BMS-986405 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 with BMS-986405 (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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-29
• Study Start: 2019-08-26
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30
• Primary Completion: 2024-08-23
• Study Completion: 2024-08-23

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2 (CC-99712 and BMS-986405 combination)	CC-99712	CC-99712 will be administered via IV infusion. BMS-986405 will be administered orally.
Arm 2 (CC-99712 and BMS-986405 combination)	BMS-986405	CC-99712 will be administered via IV infusion. BMS-986405 will be administered orally.
Arm 1 (CC-99712 monotherapy)	CC-99712	CC-99712 will be administered via intravenous (IV) infusion.

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD) in participants with relapsed and refractory MM	Up to 28 days	Is defined as the highest dose that causes DLTs in no more than 33% of patient population during the first cycle of treatment.
Dose Limiting Toxicity (DLT) in participants with relapsed and refractory MM	Up to 28 days	Is defined as any of the following toxicities occurring within the DLT assessment window
Adverse Events (AEs)	From enrollment until at least 42 days after completion of study treatment	Number of participants with adverse event

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics- CLT	Up to 3 years	Total body clearance of the drug from the serum
Presence and frequency of ADA using a validated bridging immunoassay with electrochemiluminescence detection	Up to 3 years	Anti-CC-99712 antibodies
Pharmacokinetics- Cmax	Up to 3 years	Maximum plasma concentration of drug
Pharmacokinetics- AUC(TAU)	Up to 3 years	Area under the serum concentration time-curve
Pharmacokinetics- Ctrough	Up to 3 years	Lowest concentration of drug immediately prior to administration of the next dose
Duration of Response	Up to 3 years	Is defined as the time from the earliest date of documented response (≥ PR) to the first documented disease progression or death, whichever occurs first.
Overall Response Rate (ORR)	Up to 3 years	Is defined as the proportion of participants who achieve a partial response or better (eg, Partial response (PR), Very good partial response (VGPR), Complete response (CR) or sCR), according to IMWG response criteria.
Time to Response	Up to 3 years	Is defined as the time from the first CC-99712 dose date to the date of first documented response (PR or better).
Overall Survival (OS)	Up to 3 years	Is defined as the time from the first dose of CC-99712 to death from any cause.
Progression-free Survival (PFS)	Up to 3 years	Is defined as the time from the first dose of CC-99712 to progressive disease (PD) or death from any cause, whichever occurs first.
Pharmacokinetics- Tmax	Up to 3 years	Time to peak (maximum) serum concentration

Trial Locations

Locations (20)

Local Institution - 102; 🇺🇸 Seattle, Washington, United States

Local Institution - 104; 🇺🇸 Dallas, Texas, United States

Local Institution - 202; 🇨🇦 Toronto, Ontario, Canada

Local Institution - 401; 🇪🇸 Madrid, Spain

Local Institution - 103; 🇺🇸 Buffalo, New York, United States

Local Institution - 105; 🇺🇸 Sarasota, Florida, United States

Local Institution - 107; 🇺🇸 La Jolla, California, United States

Hopital Saint Antoine; 🇫🇷 Paris, France

Local Institution - 305; 🇫🇷 Pierre Bénite, France

Local Institution - 0505; 🇪🇸 Malaga, Spain

Local Institution - 402; 🇪🇸 Salamanca, Spain

Local Institution - 106; 🇺🇸 New York, New York, United States

Local Institution - 501; 🇮🇹 Bologna, Italy

Institut Paoli Calmettes; 🇫🇷 Marseille Cedex 9, France

CHU Montpellier - Hôpital Saint Eloi; 🇫🇷 Montpellier CEDEX 5, France

Local Institution - 405; 🇪🇸 Barcelona, Spain

Local Institution - 403; 🇪🇸 Valencia, Spain

Local Institution - 101; 🇺🇸 Portland, Oregon, United States

Local Institution - 404; 🇪🇸 Sevillla, Spain

Local Institution - 201; 🇨🇦 Montreal, Quebec, Canada