OncoMatch/Clinical Trials/NCT03526835
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
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
Is NCT03526835 recruiting? Yes, currently enrolling (Oct 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, to be confirmed by the sponsor, and must have an MSS tumor.
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, to be confirmed by the sponsor, and must have an MSS tumor.
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, to be confirmed by the sponsor, and must have an MSS tumor.
Excluded: KRAS missense mutation
No oncogenic missense mutations in KRAS, NRAS, BRAF, or EGFR ectodomain, as detected in plasma by ctDNA NGS central testing performed during screening.
Excluded: NRAS missense mutation
No oncogenic missense mutations in KRAS, NRAS, BRAF, or EGFR ectodomain, as detected in plasma by ctDNA NGS central testing performed during screening.
Excluded: BRAF missense mutation
No oncogenic missense mutations in KRAS, NRAS, BRAF, or EGFR ectodomain, as detected in plasma by ctDNA NGS central testing performed during screening.
Excluded: EGFR ectodomain missense mutation
No oncogenic missense mutations in KRAS, NRAS, BRAF, or EGFR ectodomain, as detected in plasma by ctDNA NGS central testing performed during screening.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiotherapy to ≥25% of bone marrow
Patients who received prior radiotherapy to ≥25% of bone marrow are not eligible, irrespective of when it was received.
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 radiotherapy to ≥25% of bone marrow 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 qualifyRelated pages