Treatment of EGFR-positive advanced or metastatic solid tumors with MRG003 and HX008

An Open-label, Multi-center, Phase I/II Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of MRG003 in Combination With HX008 in Patients With EGFR-positive Advanced Solid Tumors

This study is testing a new combination treatment for patients with advanced or metastatic solid tumors that have EGFR-positive markers to see how safe and effective it is.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Miracogen Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 2 sites (Guangzhou, Guangdong and 1 other locations)
• Trial ID: NCT05688605 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in combination with HX008 for patients with EGFR-positive advanced or metastatic solid tumors. It consists of two phases: Phase I focuses on determining the maximum tolerated dose and safety profile, while Phase II assesses preliminary efficacy and pharmacokinetics. Patients will be monitored for their response to the treatment and any adverse effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with EGFR-positive advanced or metastatic solid tumors, such as non-small cell lung cancer or head and neck cancers.

Not a fit: Patients with severe cardiac dysfunction or those who have a history of hypersensitivity to any component of the investigational drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat EGFR-positive solid tumors.

How similar studies have performed: Other studies involving antibody drug conjugates targeting EGFR have shown promise, indicating potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

1. Willing to sign the informed consent form and follow the requirements specified in the protocol.
2. Aged 18 to 75 (including 18 and 75), both genders.
3. BMI ≥17
4. Life expectancy ≥ 12 weeks.
5. Patients with EGFR-positive advanced or metastatic solid tumors, including non-small cell lung cancer (NSCLC), squamous cell carcinoma of head and neck (SCCHN), and nasopharyngeal carcinoma (NPC).
6. EGFR-positive determined by immunohistochemistry (except NSCLC, SCCHN and NPC).
7. Patients must have measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
8. The score of ECOG for performance status is 0 or 1.
9. No severe cardiac dysfunction.
10. Acceptable liver, renal, and hematologic function.
11. Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.

Exclusion Criteria:

1. History of hypersensitivity to any component of the investigational product.
2. Prior treatment with chemotherapy, biological therapy, immunotherapy, radiotherapy, investigational drugs, attenuated live vaccines, immunomodulators, CYP3A4 inhibitors/inducers, antibody-drug conjugates, Received major surgery without complete recovery, etc.
3. Treatment with MMAE/MMAF ADC drugs
4. Central nervous system metastasis.
5. Toxic reaction or abnormal value of laboratory test caused by previous anti-tumor treatment ≥ 2 (CTCAE v5.0)
6. Presence of peripheral neuropathy ≥ Grade 2.
7. Liver function Child Pugh Grade B or Grade C。
8. Pleural and peritoneal effusion or pericardial effusion with clinical symptoms requiring drainage.
9. Poorly controlled systemic diseases (hypertension and hyperglycemia, etc.)
10. Evidence of active infection of hepatitis B, hepatitis C or HIV.
11. Patients with poorly controlled heart diseases
12. History of ophthalmic abnormalities.
13. History of severe skin disease requiring oral or intravenous therapy.
14. History of interstitial pneumonia, radiation pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.
15. Active, known or suspected autoimmune disease or drug related immune disease or the disease history within the past 2 years.
16. The patient is using immunosuppressant or systemic hormone therapy.
17. Patients with any past arteriovenous bleeding within 3 months or current history of coagulation disorder.
18. Any clinically significant VTE occurred within 6 months.
19. Received allogeneic tissue/solid organ transplantation.
20. Inoculate live vaccine within 30 days before the first dose.
21. Patients with a positive serum pregnancy test or who are breast-feeding or who do not agree to take adequate contraceptive measures during the treatment and for 180 days after the last dose of study treatment.
22. History of other primary malignant tumor diseases.
23. Investigator considers which not suitable to participate in the clinical trial

Where this trial is running

Guangzhou, Guangdong and 1 other locations

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Ruihua Xu, M.D. — Sun Yat-sen University
• Study coordinator: Program Director

Conditions Advanced Solid Tumors; MRG003; HX008; Antibody Drug Conjugate; EGFR; Solid tumors