Can a drug duo shrink Hard-to-Treat tumors?
NCT ID NCT05688605
First seen Sep 04, 2026 · Last updated Sep 04, 2026
Summary
This early-phase trial tests whether combining two experimental drugs, MRG003 and HX008, can safely shrink tumors in people with advanced solid cancers that carry a protein called EGFR. The study includes adults with non-small cell lung cancer, head and neck cancer, or nasopharyngeal cancer. Researchers will first find the safest dose, then measure how many tumors respond to the combination.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MRG003 combined with HX008, given intravenously
- What this could lead to
- If it works, this combination could offer a new treatment option for people with advanced solid tumors that have not responded to other therapies.
- What could go wrong
- This is an early-phase trial with only 18 participants, so the treatment may not be effective or may cause side effects. The results will need confirmation in larger studies.
Why investors are watching
LePu Biopharma is testing MRG003 combined with HX008 in 18 patients with EGFR-positive advanced solid tumors. For a small publicly traded company, this early-stage readout on safety and disease control could shape its pipeline value and future development plans.
If it works: A positive result showing the combination is safe and controls tumor growth could strengthen LePu's position in EGFR-targeted therapies and support further clinical development.
If it fails: The trial is small and early, and many such studies fail to show enough benefit or reveal safety problems. A poor outcome or delay could hurt the company's prospects, since it has few other public catalysts.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2022
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Hunan Cancer Hospital
NOT_YET_RECRUITINGChangsha, Hunan, 410029, China
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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510060, China
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