First-in-human Single Agent Study of SAR442257 in RRMM and RR-NHL (NCT04401020) | Clinical Trial Compass
Active — Not RecruitingPhase 1
First-in-human Single Agent Study of SAR442257 in RRMM and RR-NHL
United States, Czechia47 participantsStarted 2020-07-24
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria :
Participant must be at least 18 years of age or of the country's legal age of majority if the legal age is \>18 years old, at the time of signing the informed consent.
Life expectancy of at least 12 weeks. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
RRMM patients:
must have received at least 3 prior lines of therapy including proteasome inhibitor (PI), immunomodulatory agent (IMiD), and anti-CD38 mAb;
and must be refractory to anti-CD38 antibody (eg, daratumumab or isatuximab), characterized by progression within 60 days of the last dose of anti-CD38, regardless of which line it was given; and must be either relapsed or refractory to all established therapies with known clinical benefit in RRMM where approved and available, or are intolerant to those established therapies; based upon investigator's clinical judgement.
and must not be candidates for regimens known to provide clinical benefit based upon investigator's clinical judgement.
Patients with RRMM must have measurable disease as per the following:
* Serum M protein ≥0.5 g/dL (≥5 g/L), or
* Urine M protein ≥200 mg/24 hours, or
* Serum free light chain (FLC) assay: involved FLC assay ≥10 mg/dL and an abnormal serum FLC ratio (\<0.26 or \>1.65).
Patients with RR-NHL must be relapsed or refractory to all established therapies with known clinical benefit where approved and available, or are intolerant to those established therapies; based upon investigator's clinical judgem…