OncoMatch/Clinical Trials/NCT07085091
A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors
Official title: A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants With Advanced or Metastatic Select Solid Tumors
Is NCT07085091 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies ALX2004 for nsclc (advanced non-small cell lung cancer).
Treatment: ALX2004 — A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants with Advanced or Metastatic Select Solid Tumors
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Head and Neck Squamous Cell Carcinoma
Colorectal Cancer
Esophageal Carcinoma
Biomarker criteria
Required: MLH1 loss
CRC - For participants with a targetable molecular alteration (including dMMR or MSI-H): Received appropriate standard therapy for the alteration
Required: MSH2 loss
CRC - For participants with a targetable molecular alteration (including dMMR or MSI-H): Received appropriate standard therapy for the alteration
Required: MSH6 loss
CRC - For participants with a targetable molecular alteration (including dMMR or MSI-H): Received appropriate standard therapy for the alteration
Required: PMS2 loss
CRC - For participants with a targetable molecular alteration (including dMMR or MSI-H): Received appropriate standard therapy for the alteration
Prior therapy
Must have received: anticancer therapy — advanced/metastatic
Dose Escalation: Participants who have relapsed or progressed following prior anticancer therapy in the advanced/metastatic setting and for whom no approved or standard therapy is available.
Cannot have received: antibody-drug conjugate with active TOP1 inhibitor-based component
Prior treatment with any ADCs that have an active TOP1 inhibitor-based component
Lab requirements
Blood counts
adequate bone marrow function
Kidney function
adequate renal function
Liver function
adequate liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- ALX Center 7 · Tampa, Florida
- ALX Center 8 · Farmington Hills, Michigan
- ALX Center 3 · Grand Rapids, Michigan
- ALX Center 6 · Portland, Oregon
- ALX Center 5 · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07085091 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior antibody-drug conjugate with active TOP1 inhibitor-based component disqualifies patients from enrollment.
Does this trial require MLH1?
Yes, MLH1 loss is a required biomarker for enrollment.
Does this trial require MSH2?
Yes, MSH2 loss is a required biomarker for enrollment.
Does this trial require MSH6?
Yes, MSH6 loss is a required biomarker for enrollment.
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