Phase I/II clinical trial - Recherches "plusieurs pathologies"

MCLA-128-CL01
Recherches "plusieurs pathologies"
Ouvert depuis le: 09.22.2021
Site: Saint-Cloud
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A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion
Description de l'essai

This open label (all participants know the identity of the study drug), multicenter (more than one study site), first-in-human study consisting of 2 parts. Part 1 is a dose escalation and Part 2 is a dose expansion cohort. Part 1 has been completed.;Part 2 new patient populations examined:;ÀGroup F: Patients with NSCLC with documented NRG1 fusion;ÀGroup G: Patients with pancreatic cancer with documented NRG1 fusion;ÀGroup H: Patients with any other solid tumor with documented NRG1 fusion;For these new patient populations, Part 2 will further characterize the safety and tolerability of the selected dose level of zenocutuzumab (MCLA-128), as well as assessment of CBR, defined as the proportion of patients with a CR, PR or durable SD (SD for at least 12 weeks in duration). For the new patient populations, overall response rate (ORR) and duration of response (DOR) will be described.;The study consists of 3 periods: Screening period (up to 28 days prior to the first dose of study drug); Treatment period (treatment cycles of 28 days); and Follow Up period (through 30 days after the last dose and quarterly checks for survival data for up to 2 years). Participants' safety will be monitored throughout the study.