A Study of MRG007 in Patients With Advanced Solid Tumors

Launched by SHANGHAI MIRACOGEN INC. · Jul 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called MRG007 to see if it is safe and helpful for people with advanced solid tumors—these are cancers that have grown large or spread to other parts of the body and cannot be removed by surgery. The trial is an early-phase study, which means researchers are mainly looking at how the medicine affects the body, how well it works, and whether it causes any side effects. The study will take place at multiple centers, and it is not yet open for new participants.

People who might be eligible for this trial are adults with certain types of advanced cancer that have not responded to standard treatments or for whom no other standard treatments are available. Participants need to have at least one tumor that can be measured on scans and must be in relatively good health with a life expectancy of at least three months. They’ll also need to agree to provide a tumor sample for testing or have a biopsy before starting treatment. During the trial, participants will receive MRG007 and be closely monitored by the medical team for any side effects or changes in their cancer. It’s important to know that some people won’t qualify, such as those with certain infections, recent other cancer treatments, or severe health conditions. If you or a loved one are considering this trial, the research team will carefully review medical history to ensure safety and suitability.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Willing to sign the informed consent form and follow the requirements specified in the protocol.
• • 2. Life expectancy ≥ 3 months.
• • 3. Tumor specimen available for Cadherin17 (CDH17) testing, or agree to biopsy at baseline.
• • 4. Patients with histologically and cytologically confirmed advanced or metastatic solid tumor who have failed or intolerant to standard therapy, or without alternative standard therapy.
• • 5. Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
• • 6. The score of Eastern Cooperative Oncology Group (ECOG) for performance status is 0 or 1.
• • 7. Organ functions and coagulation function must meet the basic requirements.
• • 8. Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.
• Exclusion Criteria:
• • 1. Patients with more than one cancer.
• • 2. Received CDH17-targeting anti-tumor therapy; received other investigational product, anti-tumor therapy, radiotherapy, surgery for major organs, or systemic corticosteroid treatment within 4 weeks prior to the first dose of study treatment; received strong CYP3A4 inducers or inhibitors, or small molecular targeting therapy within 2 weeks prior to the first treatment or 5 half-lives of such therapy, whichever is longer.
• • 3. ≥Grade 1 toxic reaction or abnormal value of laboratory test caused by previous anti-tumor treatment
• • 4. Central nervous system and/or meninges metastasis.
• • 5. History of severe cardiovascular diseases
• • 6. Cerebrovascular accident, pulmonary embolism, or deep venous thrombosis, implantable venous infusion port or catheter-related thrombosis, or superficial venous thrombosis occurred within 3 months prior to the first treatment.
• • 7. History of previous or combined interstitial pneumonia, current interstitial pneumonia, or suspected interstitial pneumonia that cannot be ruled out through imaging during screening, severe chronic obstructive pulmonary disease with respiratory failure, severe pulmonary dysfunction, symptomatic bronchospasm, etc.
• • 8. Poorly controlled pleural, peritoneal, and pelvic effusion, or combined pericardial effusion
• • 9. Infection of active hepatitis B, active hepatitis C, or HIV
• • 10. Uncontrolled active bacterial, viral, fungal, rickettsial, or parasitic infections requiring intravenous anti-infection therapy within 2 weeks prior to the first study treatment
• • 11. Known allergic reactions to any component of MRG007, or known Grade≥3 allergic reactions to other prior anti-CDH17 (including investigational) or other monoclonal antibody.
• • 12. Other situations that are not suitable to participate a clinical trial per investigator's judgement