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

NCT03526835 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 523

Last updated 2025-01-29

No results posted yet for this study

Summary

This is a Phase 1/2 open-label, multi-center, multi-national study with an initial dose escalation part to determine the recommended Phase II dose (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 and metastatic colorectal cancer (mCRC).

The study will further assess the safety, tolerability, PK, PD, immunogenicity, and anti-tumor activity of MCLA-158 in monotherapy or in combination with other therapies.

Conditions

Interventions

DRUG

MCLA-158

full-length IgG1 bispecific antibody targeting EGFR and LGR5

COMBINATION_PRODUCT

MCLA-158 + Pembrolizumab

MCLA-158 in combination with pembrolizumab will be explored first in HNSCC patients eligible to receive pembrolizumab as first-line monotherapy.

COMBINATION_PRODUCT

MCLA-158 + FOLFIRI

MCLA-158 in combination with FOLFIRI will be explored in mCRC patients with up to 1 line of prior regimen.

COMBINATION_PRODUCT

MCLA-158 + FOLFOX

MCLA-158 in combination with FOLFOX will be explored in mCRC patients with up to 1 line of prior regimen.

Sponsors & Collaborators

  • Merus N.V.

    lead INDUSTRY

Principal Investigators

  • Gianluca Laus, MD · Merus N.V.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-02
Primary Completion
2025-11-30
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03526835 on ClinicalTrials.gov