OncoMatch/Clinical Trials/NCT03526835
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Is NCT03526835 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments including MCLA-158 and MCLA-158 + Pembrolizumab for advanced/metastatic solid tumors.
Treatment: MCLA-158 · MCLA-158 + Pembrolizumab · MCLA-158 + FOLFIRI · MCLA-158 + FOLFOX — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Tumor Agnostic
Colorectal Cancer
Gastric Cancer
Esophageal Carcinoma
Non-Small Cell Lung Carcinoma
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: MSI1 microsatellite stable
A microsatellite stable (MSS) tumor
Required: KRAS wild-type
Patients must be RAS/ RAF WT as determined using tumor tissue (primary or metastatic) by an appropriate tumor tissue based assay
Required: NRAS wild-type
Patients must be RAS/ RAF WT as determined using tumor tissue (primary or metastatic) by an appropriate tumor tissue based assay
Required: BRAF wild-type
Patients must be RAS/ RAF WT as determined using tumor tissue (primary or metastatic) by an appropriate tumor tissue based assay
Required: PD-L1 (CD274) expression (CPS ≥1)
tumors expressing programmed cell death protein ligand 1 (PD-L1), combined positive score (CPS) ≥1, as determined by a Food and Drug Administration (FDA) approved test in the US, or by an approved equivalent test in other countries
Excluded: KRAS missense mutation
No oncogenic missense mutations in KRAS, NRAS, BRAF, or EGFR ectodomain
Excluded: NRAS missense mutation
No oncogenic missense mutations in KRAS, NRAS, BRAF, or EGFR ectodomain
Excluded: BRAF missense mutation
No oncogenic missense mutations in KRAS, NRAS, BRAF, or EGFR ectodomain
Excluded: EGFR ectodomain missense mutation
No oncogenic missense mutations in KRAS, NRAS, BRAF, or EGFR ectodomain
Excluded: HER2 (ERBB2) amplification
no HER2 (ERBB2) or KRAS amplification
Excluded: KRAS amplification
no HER2 (ERBB2) or KRAS amplification
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — HNSCC, recurrent or metastatic disease
patients who have progressed on or after, or are intolerant to, anti-PD-(L)1 therapy and platinum therapy as monotherapy or in combination with other agents
Must have received: anti-PD-1 therapy — HNSCC, recurrent or metastatic disease
patients who have progressed on or after, or are intolerant to, anti-PD-(L)1 therapy and platinum therapy as monotherapy or in combination with other agents
Must have received: chemotherapy with oxaliplatin, irinotecan, and a fluoropyrimidine — mCRC, metastatic setting
Received ≥2 and no more than 4 lines of prior therapy in the metastatic setting including: 1. Chemotherapy with oxaliplatin, irinotecan, and a fluoropyrimidine
Must have received: anti-VEGF therapy — mCRC, metastatic setting
Received ≥2 and no more than 4 lines of prior therapy in the metastatic setting including: 2. Targeted therapy with an anti-VEGF therapy
Cannot have received: EGFR inhibitor
no previous exposure to EGFR inhibitors
Cannot have received: anti-EGFR therapy
Patients must be naive to prior anti-EGFR therapy
Lab requirements
Blood counts
Kidney function
Liver function
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA)
Adequate organ function; Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCSD · La Jolla, California
- USC Norris Comprehensive Cancer Center · Los Angeles, California
- Sharp Healthcare · San Diego, California
- Rocky Mountain Cancer Centers · Lone Tree, Colorado
- Florida Cancer Specialists · Fort Myers, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT03526835 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior EGFR inhibitor, anti-EGFR therapy disqualifies patients from enrollment.
Does this trial require MSI1?
Yes, MSI1 microsatellite stable is a required biomarker for enrollment.
Does this trial require KRAS?
Yes, KRAS wild-type is a required biomarker for enrollment.
Does this trial require NRAS?
Yes, NRAS wild-type is a required biomarker for enrollment.
Are patients with KRAS alterations eligible?
No. KRAS missense mutation is an exclusion criterion.
Are patients with NRAS alterations eligible?
No. NRAS missense mutation is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify