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Two-Drug combo aims to shrink head and neck tumors before surgery

NCT ID NCT07677475

Disease control Sponsor: Dongguan People's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Last updated Aug 06, 2026 · Updated 4 times

Summary

This phase 2 trial tests whether adding MRG003 (a targeted drug) to toripalimab (an immunotherapy) before surgery can shrink tumors more than toripalimab alone in people with PD-L1-positive, locally advanced head and neck cancer. Participants receive two cycles of either the combination or toripalimab alone, followed by surgery and additional therapy. The main goal is to see how many patients have a major reduction in tumor cells after treatment.

What this could mean

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

Active substance
MRG003 (becotatug vedotin) and toripalimab
What this could lead to
If successful, this combination could shrink tumors more effectively before surgery, potentially improving long-term outcomes for people with head and neck cancer.
What could go wrong
This is an early-phase trial with a small number of participants. The combination may not prove better than toripalimab alone, and side effects from the two drugs could be more severe.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 65 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 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.

1. Histologically or cytologically confirmed head and neck squamous cell carcinoma (HNSCC), PD-L1 positive (CPS ≥ 1) 2. Treatment-naïve, pathologically confirmed stage III-IVA resectable non-oropharyngeal HNSCC (oral cavity, larynx, hypopharynx) OR HPV-negative oropharyngeal SCC, OR HPV-positive stage III T4N0-2 resectable oropharyngeal cancer (AJCC 8th edition) 3. No prior antitumor treatment (radiotherapy, chemotherapy, targeted therapy, or immunotherapy) 4. Age 18 to 70 years 5. ECOG performance status 0 or 1 6. Adequate organ function within 14 days before first dose (no blood products or growth factors within 14 days): * ANC ≥ 1.0 × 10⁹/L, Hb ≥ 90 g/L, PLT ≥ 75 × 10⁹/L * ALT/AST ≤ 1.5 × ULN, total bilirubin ≤ 1.5 × ULN, ALP \< 2.5 × ULN * CrCl ≥ 50 mL/min (Cockcroft-Gault) * APTT and INR ≤ 1.5 × ULN 7. At least one measurable lesion per RECIST 1.1 8. Life expectancy ≥ 12 weeks 9. Female subjects of childbearing potential and male subjects with reproductive potential must use medically accepted contraception during treatment and for 3 months after last dose 10. Voluntary signed informed consent, good compliance, willing to undergo follow-up

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

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

Head and neck squamous cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

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

  2. 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 ↗

  3. 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

Locations

  • The Tenth Affiliated Hospital of Southern Medical University (Dongguan People's Hospital)

    Dongguan, Guangdong, 523059, China

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Other studies related to the condition(s) this trial covers.