Can a drug duo shrink Hard-to-Treat tumors?

NCT ID NCT05688605

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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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How to take part

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites. The list below names each one and where it is.

  3. The official record

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    Open the record ↗

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Hunan Cancer Hospital

    NOT_YET_RECRUITING

    Changsha, Hunan, 410029, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

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