Spots Global Cancer Trial Database for A Study of Bispecific Antibody MCLA-145 in Patients With Advanced or Metastatic Malignancies

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Trial Identification

Brief Title: A Study of Bispecific Antibody MCLA-145 in Patients With Advanced or Metastatic Malignancies

Official Title: A Phase 1, Open-Label, Dose-Escalation, Safety, Tolerability, and Preliminary Efficacy Study of MCLA-145 in Participants With Advanced or Metastatic Malignancies

Study ID: NCT03922204

Conditions

Advanced Cancer

Solid Tumor, Adult

B-cell Lymphoma, Adult

Interventions

MCLA-145

Study Description

Brief Summary: This is a Phase 1, open label, non-randomised, dose-escalation single agent study with expansion cohorts for dose confirmation/safety and preliminary efficacy of MCLA-145 in advanced or metastatic malignancies

Detailed Description: Study Design: This open label, multicenter, first in human study consists of 2 parts. Part 1 is a dose escalation to find the recommended dose for the expansion. Part 2 is a dose expansion to confirm the dose of MCLA-145 through further evaluation of safety, tolerability, Pk, preliminary antitumor activity, and functional target engagement. The study includes three periods: Screening( up to 28 days prior to the first dose of study drug); Treatment( first dose of study drug with treatment cycles of 28 days); and Follow-up ( 30 days and 90 days after the last dose) including survival follow-up checks every 2 months up to 12 months after the last dose.