New drug cocktail aims to outdo chemo for tough throat cancer

NCT ID NCT06976190

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Sep 01, 2026 · Updated 3 times

Summary

This Phase 3 trial tests whether combining two drugs, MRG003 and pucotenlimab, works better than standard chemotherapy for people with nasopharyngeal cancer that has returned or spread. About 446 participants will be randomly assigned to receive either the new combo or one of three chemo drugs. The main goals are to see if the combo delays cancer growth and improves overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MRG003 and pucotenlimab (drug combination)
What this could lead to
If successful, this combination could offer a new treatment option for people with nasopharyngeal cancer that has come back or spread, potentially improving survival compared to standard chemotherapy.
What could go wrong
This is an early-stage Phase 3 trial, so results are not yet known. The combination may not work better than chemotherapy and could have side effects like immune-related reactions or infusion reactions.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 446 people

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

Started

May 2025

Expected to finish

Dec 2030

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: * Willing to sign the informed consent form and follow the requirements specified in the protocol. * Life expectancy ≥ 12 weeks. * Patients with histologically and cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma (NPC) who have failed at least one line of prior systemic therapy. * Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). * The score of ECOG for performance status is 0 or 1. * No severe cardiac dysfunction, left ventricular ejection fraction (LVEF) ≥50%. * Organ functions and coagulation function must meet the basic requirements. * Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment. Exclusion Criteria: * History of hypersensitivity to any component of the investigational product. * Received systemic chemotherapy, targeted therapy, biological therapy or immunotherapy for anti-tumor purpose, or major surgery within 3 weeks prior to the first dose of study treatment. * Received anti-infection therapy within 2 weeks prior to the randomization * Prior treatment with MMAE/MMAF ADC drugs * Central nervous system metastasis. * Poorly controlled systemic diseases * Patients with poorly controlled heart diseases * Poorly controlled pleural and peritoneal effusion or pericardial effusion * ≥Grade 2 toxic reaction or abnormal value of laboratory test caused by previous anti-tumor treatment * Patients with prior ≥Grade 3 immuno-related adverse events (irAEs) * Any clinically significant arteriovenous bleeding, pulmonary embolism, or deep venous thrombosis occurred within 3 months * Received allogeneic tissue/solid organ transplantation. * Inoculate live vaccine within 30 days before the first dose. * 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. * History of other primary malignant tumor diseases. * Other situations that are not suitable to participate a clinical trial per investigator's judgement

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

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