First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma
- Registration Number
- NCT04000282
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objectives:
* Dose Escalation Part A: To determine the maximum tolerated dose (MTD) of SAR442085 administered as a single agent in patients with relapsed or refractory multiple myeloma (RRMM), and determine the recommended Phase 2 dose (RP2D) for the subsequent Expansion Part B
* Dose Expansion Part B: To assess the antitumor activity of single agent of SAR442085 at the RP2D in patients with RRMM
Secondary Objectives:
* To characterize the safety profile of SAR442085
* To characterize the pharmacokinetics (PK) profile of SAR442085 when administered as a single agent
* To evaluate the potential immunogenicity of SAR442085
* To assess preliminary evidence of antitumor activity in the Dose Escalation Part A
- Detailed Description
Patient will continue to receive study medication until disease progression, unacceptable toxicity, withdrawal of informed consent, or other reason why investigator considers it appropriate to discontinue study medication. Once permanently discontinued, study medication cannot be restarted at later timepoint.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 37
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A: SAR442085 dose escalation SAR442085 SAR442085 will be given intravenously weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle until the patient has progressive disease, unacceptable toxicity or other reasons to terminate study treatment. Each cycle will be approximately 28 days in duration. Part B: SAR442085 dose expansion SAR442085 SAR442085 will be given intravenously weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle until the patient has progressive disease, unacceptable toxicity or other reasons to terminate study treatment. Each cycle will be approximately 28 days in duration.
- Primary Outcome Measures
Name Time Method The maximum tolerated dose (MTD) of SAR442085 (Part A) At the end of Cycle 1 (each cycle is approximately 28 days) MTD is defined as the dose level with highest probability of investigational medicinal product (IMP) related dose limiting toxicity (DLT) rate within the target range (16 to 33%) among dose levels with less than 0.25 probability of DLT rate above target (\>33%)
Recommended Phase 2 dose (RP2D) (Part A) At the end of Cycle 1 (each cycle is approximately 28 days) RP2D is defined as the dose selected for the further single agent testing - including in Phase 1 expansion part B.
Overall response rate (Part B) approximately 6 months after the last patient has started treatment in Part B (approx. 2 years) Overall response rate (ORR): is defined as the proportion of patients with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR), using the International Myeloma Working Group (IMWG) criteria.
- Secondary Outcome Measures
Name Time Method Anti-drug antibody (ADA) against SAR442085 (Both Part A and B) Cycle 1, 2, 3, 6 and 9 (each cycle is approximately 28 days) Number of participants with ADA against SAR442085.
Progression-free survival (Part B) approximately 12 months after the last patient has started treatment in Part B (approx. 2 years) Progression-free survival (PFS) is defined as the time interval from the date of enrollment to the date of documented tumor progression as per IMWG or death (due to any cause), whichever comes first.
Duration of response (Part B) approximately 12 months after the last patient has started treatment in Part B (approx. 2 years) Duration of response (DOR) is defined as the time from first documented evidence of CR or PR until progressive disease (PD) as per IMWG or death from any cause, whichever occurs first.
Treatment-emergent adverse events (AEs)/serious adverse events (SAE) (Both Part A and B) From baseline to end of treatment + 30 days (approx. 2 years) Number of participants with Treatment-Emergent Adverse events (TEAEs) from baseline to End of Study.
PK parameters of SAR442085: Cmax (Both Part A and B) Cycle 1 Day 1 to Day 28 Maximum plasma concentration observed (Cmax).
PK parameters of SAR442085: Tmax (Both Part A and B) Cycle 1 Day 1 to Day 28 First time to reach Cmax (tmax).
PK parameters of SAR442085: AUC (Both Part A and B) Cycle 1 Day 1 to Day 28 Area under the plasma concentration versus time curve extrapolated to infinity (AUC).
Trial Locations
- Locations (12)
Investigational Site Number : 2030002
🇨🇿Brno, Czechia
Investigational Site Number : 2030003
🇨🇿Ostrava - Poruba, Czechia
City of Hope Site Number : 8400002
🇺🇸Duarte, California, United States
Investigational Site Number : 2030001
🇨🇿Praha 2, Czechia
Dana Farber Cancer Institute Site Number : 8400003
🇺🇸Boston, Massachusetts, United States
Investigational Site Number : 2500001
🇫🇷TOULOUSE Cedex 9, France
Investigational Site Number : 3000001
🇬🇷Athens, Greece
Investigational Site Number : 7240001
🇪🇸Salamanca, Spain
Mayo Clinic of Rochester Site Number : 8400005
🇺🇸Rochester, Minnesota, United States
UNC Chapel Hill Site Number : 8400006
🇺🇸Chapel Hill, North Carolina, United States
Froedtert Hospital & Medical College of Wisconsin Site Number : 8400004
🇺🇸Milwaukee, Wisconsin, United States
Investigational Site Number : 1580001
🇨🇳Taipei, Taiwan