NCT03526835 A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors

Trial Parameters

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Brief 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.

Eligibility Criteria

Inclusion Criteria: * Histologically or cytologically confirmed solid tumors with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent. * A baseline fresh tumor sample (FFPE) from a metastatic or primary site (if safe/feasible). * Amenable for biopsy (if safe/feasible). * Measurable disease as defined by RECIST version 1.1 by radiologic methods. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy ≥ 12 weeks, as per investigator. * Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA). * Adequate organ function * Expansion cohorts: patients with locally advanced unresectable or metastatic disease for the following indications: SINGLE AGENT: * SECOND-/THIRD-LINE HNSCC PATIENTS (cohort closed to enrolment): patients who have progressed on or after, or are intolerant to, anti-PD-(L)1 therapy and platinum therapy as monotherapy or in combin

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