OncoMatch/Clinical Trials/NCT07085091
A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors
Is NCT07085091 recruiting? Yes, currently enrolling (Sep 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