A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors

Colorectal Cancer Clinical Trial

Official title: Phase 1/2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single Agent or in Combination in Advanced Solid Tumors

Status Recruiting

Clinical Trial Summary

This is a Phase 1/2 open-label, multi-center, multi-national study with an initial dose escalation part to determine the RP2D of MCLA-158 single agent in patients with mCRC.

The dose escalation part has been completed and the RP2D will be further evaluated in an expansion part of the study. Cohorts of selected solid tumor indications for which there is evidence of EGFR dependency and potential sensitivity to EGFR inhibition will be evaluated including head and neck cancer.

The study will further assess the safety, tolerability, PK, PD, immunogenicity, and anti-tumor activity of MCLA-158.

Clinical Trial 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 Phase II dose (RP2D) of MCLA-158 studying patients with metastatic colorectal cancer. Enrollment in the dose escalation part has been completed.

Dose expansion (single-agent cohorts) In an expansion part of the study, the activity, safety, and tolerability of MCLA-158 at 1500 mg every 2 weeks (Q2W) (preliminary RP2D) as a single agent will be evaluated in cohorts of selected solid tumor indications with dependency on EGFR signaling. Eligible solid tumor indications may include locally advanced unresectable or metastatic HNSCC, gastric/gastroesophageal junction adenocarcinoma (GEA) with EGFR amplification and/or high EGFR expression, esophageal carcinoma and pancreatic adenocarcinoma. Additionally, safety will be characterized at two dose levels in this setting.

Dose expansion (in combination with pembrolizumab cohort)

MCLA-158 in combination with pembrolizumab will be explored first in HNSCC patients eligible to receive pembrolizumab as first-line monotherapy. Other expansion cohorts may be considered for combination treatment in the future. ;

Related Conditions & MeSH terms

• Advanced/Metastatic Solid Tumors
• Colorectal Cancer
• Gastric Cancer
• Gastroesophageal-junction Cancer
• Head and Neck Squamous Cell Carcinoma
• HNSCC
• NSCLC
• Squamous Cell Carcinoma of Head and Neck

• NCT number: NCT03526835
• Study type: Interventional
• Source: Merus N.V.
• Contact: Eduardo Pennella, MD
• Phone: +1 617 401 4499
• Email: USenquiries@merus.nl
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 2, 2018
• Completion date: June 2025