Overview
This is a first-in-human study of SAR446523 conducted in patients with RRMM.
The study consists of two parts:
Dose escalation (Part A): In this part, up to several dose levels (DLs) of SAR446523 will be explored to determine the maximum administered dose (MAD), maximum tolerated dose (MTD), and recommended dose range (RDR) of 2 dose regimens which will be tested in the dose optimization part.
Dose optimization (Part B): In this part, participants will be randomly assigned in a 1:1 ratio using interactive response technology (IRT) to either one of the chosen dose regimens of SAR446523 (determined from data coming from Part A), to determine the optimal dose as the recommended phase 2 dose (RP2D) of SAR446523.
Description
The study will be considered ongoing until the last participant last visit has occurred. Participants will be allowed to continue therapy until disease progression, unacceptable AEs, participant or Investigator's request to discontinue treatment.
Eligibility
Inclusion Criteria Age 18 years or older Diagnosed with colorectal cancer Receiving outpatient chemotherapy (FOLFOX or XELOX regimen) ECOG performance status between 0 and 2 Not receiving radiotherapy No hearing or speech impairments No severe psychiatric disorders (e.g., schizophrenia, major depression, bipolar disorder) Able to understand the study procedures and provide informed consent Willing to participate in the study Exclusion Criteria ECOG performance status of 3 or higher Patients who do not meet the inclusion criteria Patients unwilling to participate in the study
