Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around

Description

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.

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

Details

Keywords

Advanced/Metastatic Solid Tumors, Colorectal Cancer, Gastric Cancer, Gastroesophageal-junction Cancer, NSCLC, HNSCC, Head and Neck Squamous Cell Carcinoma, Esophageal Cancer, Bispecific antibody, First-in-human, MCLA-158, Antibodies, Bispecific, immunologic factors, Cytokines, EGFR, LGR5, Squamous Cell Carcinoma of Head and Neck, Pembrolizumab, MCLA-158 + Pembrolizumab, MCLA-158 + FOLFIRI, MCLA-158 + FOLFOX

Eligibility

Locations

  • UCSD accepting new patients
    La Jolla California 92093 United States
  • Sharp Healthcare accepting new patients
    San Diego California 92123 United States
  • USC Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merus N.V.
ID
NCT03526835
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 523 study participants
Last Updated