NCT03922204

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Merus B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, non-randomized, Phase 1 study to determine the safety, tolerability, and preliminary efficacy of MCLA-145 in adult patients with advanced metastatic solid tumors or B-cell lymphomas. The study will be conducted in 2 parts.

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 of MCLA-145 in monotherapy or in combination with pembrolizumab. Part 2 is a dose expansion to confirm the dose of MCLA-145, alone or in combination 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 for patients treated Q2W and 21 days for patients treated Q3W); Safety Follow-up (30 and 90 days after the last dose) including survival follow-up checks every 2 months up to 12 months after the last dose.

Conditions

• Advanced Cancer
• Solid Tumor, Adult
• B-cell Lymphoma, Adult

Interventions

Type	Name	Description
DRUG	MCLA-145	full-length IgG1 bispecific antibody specifically targeting PD-L1 and CD137
DRUG	Pembrolizumab (Keytruda)	Group B patients will be treated in combination with MCLA-145 and pembrolizumab 200mg Q3W.

Timeline

• Start date: 2019-05-08
• Primary completion: 2024-11-07
• Completion: 2024-11-07
• First posted: 2019-04-19
• Last updated: 2024-12-11

Locations

8 sites across 4 countries: United States, Belgium, Netherlands, Spain

Regulatory

• FDA-regulated drug study