OncoMatch/Clinical Trials/NCT03526835
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Is NCT03526835 recruiting? Yes, currently enrolling (May 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
Cancer type
Tumor Agnostic
Colorectal Cancer
Gastric Cancer
Non-Small Cell Lung Carcinoma
Head and Neck Squamous Cell Carcinoma
Esophageal Carcinoma
Biomarker criteria
Required: KRAS oncogenic missense mutation (wild-type required)
No oncogenic missense mutations in KRAS, NRAS, BRAF, or EGFR ectodomain
Required: NRAS oncogenic missense mutation (wild-type required)
No oncogenic missense mutations in KRAS, NRAS, BRAF, or EGFR ectodomain
Required: BRAF oncogenic missense mutation (wild-type required)
No oncogenic missense mutations in KRAS, NRAS, BRAF, or EGFR ectodomain
Required: EGFR ectodomain mutation (wild-type required)
No oncogenic missense mutations in KRAS, NRAS, BRAF, or EGFR ectodomain
Required: HER2 (ERBB2) amplification (wild-type required)
no HER2 (ERBB2) amplification
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: EGFR wild-type
Patients must be RAS/RAF WT as determined using tumor tissue (primary or metastatic) by an appropriate tumor tissue based assay
Required: HER2 (ERBB2) wild-type
Patients must be naive to prior anti-EGFR therapy
Required: PD-L1 (CD274) expression, CPS ≥1 (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
Disease stage
Metastatic disease required
metastatic or locally advanced disease not amenable to standard therapy with curative intent
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — adjuvant or multimodal for locally advanced disease
Patients treated with platinum-containing therapy only in the adjuvant setting, or in the context of multimodal therapy for locally advanced disease should have disease progression within 6 months of the last dose of platinum containing 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
Cannot have received: anti-PD-1 therapy
no previous exposure to anti PD-(L)1 therapies
Cannot have received: anti-PD-L1 therapy
no previous exposure to anti PD-(L)1 therapies
Lab requirements
Cardiac 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 →
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