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

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.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

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.

Locations (45)