First-in-human Single Agent Study of SAR442257 in RRMM and RR-NHL
- Registration Number
- NCT04401020
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To determine the maximum tolerated dose (MTD) of SAR442257 administered as a single agent in patients with relapsed and refractory multiple myeloma (RRMM) and relapsed and refractory non-Hodgkin lymphoma (RR-NHL), and determine the recommended Phase 2 dose (RP2D)
Secondary Objectives:
* To characterize the safety profile of SAR442257
* To characterize the pharmacokinetics (PK) profile of SAR442257
* To assess preliminary evidence of antitumor activity
- Detailed Description
Study duration per participant is 2 months to estimated 16 months. Cycle lengths in this study are 27 days in Cycle 1 and 28 days for subsequent cycles as determined by totality of data collected thus far including PK/Pharmacodynamics (PD), safety and preliminary efficacy.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 47
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose escalation SAR442257 SAR442257 will be given intravenously with lead-in doses (LID) in the first-week, followed by once weekly until week 4 (Cycle 1) and once weekly for each subsequent cycle(s).
- Primary Outcome Measures
Name Time Method Determine maximum tolerated dose (MTD) Baseline to estimated 4 weeks MTD: defined as the highest dose level (DL) 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%)
Determine recommended Phase 2 dose (RP2D) Baseline to estimated 4 months RP2D: defined as the dose selected for the further single agent testing in the future study
- Secondary Outcome Measures
Name Time Method Number of participants with AEs/SAEs/AESI Baseline to 30 days after end of treatment Incidence of treatment-emergent adverse events (AEs)/serious adverse events (SAEs)/ adverse events of special interest (AESIs) and laboratory abnormalities
Assessment of pharmacokinetic (PK) parameter: Cmax through study completion (estimated 16 months) Maximum concentration observed (Cmax)
Assessment of PK parameter: Ctrough through study completion (estimated 16 months) Concentration observed just before treatment administration during repeated dosing (Ctrough)
Assessment of PK parameter: AUC0-τ up to 4 weeks Area under the concentration versus time curve during a dosing interval (T) (AUC0-τ)
Overall response rate for RRMM Baseline to 6 months Overall response rate will be assessed using the International Myeloma Working Group (IMWG) 2016 criteria for patients with RRMM
Overall response rate for RR-NHL Baseline to 6 months Overall response rate will be assessed using the Response evaluation criteria in lymphoma (RECIL) 2017 criteria for patients with RR-NHL
Trial Locations
- Locations (16)
City of Hope Site Number : 8400001
🇺🇸Duarte, California, United States
University of Miami - Sylvester Comprehensive Cancer Center Site Number : 8400005
🇺🇸Miami, Florida, United States
Mayo Clinic of Rochester Site Number : 8400003
🇺🇸Rochester, Minnesota, United States
Investigational Site Number : 2030003
🇨🇿Brno, Czechia
Investigational Site Number : 2030001
🇨🇿Ostrava - Poruba, Czechia
Investigational Site Number : 2030002
🇨🇿Praha 2, Czechia
Investigational Site Number : 4100001
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100002
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 5780001
🇳🇴Oslo, Norway
Investigational Site Number : 5780101
🇳🇴Oslo, Norway
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