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New hope for advanced nose and throat cancer with combo therapy

NCT ID NCT07258979

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug (YL201) combined with an immunotherapy (toripalimab), with or without chemotherapy (cisplatin), in people whose nasopharyngeal cancer has come back or spread. The goal is to see if the combination is safe and helps control the cancer. About 202 adults with advanced disease will take part.

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 202 people

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

Started

Nov 2025

Expected to finish

May 2028

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. Voluntarily sign a written informed consent form (ICF). 2. Aged ≥18 years and ≤75 years, male or female. 3. ECOG performance status score of 0 or 1. 4. Life expectancy ≥ 3 months. 5. Disease and treatment history: 1. Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma that is not amenable to curative treatment. 2. Patients with newly diagnosed advanced nasopharyngeal carcinoma, categorized as Stage IV according to the 9th Edition of the American Joint Committee on Cancer (AJCC) Staging System; or those with recurrent nasopharyngeal carcinoma deemed unsuitable for local treatment 3. Metastatic or recurrent patients who are systemic treatment naïve. 6. At least one measurable lesion according to RECIST v1.1. 7. Adequate organ function. Exclusion Criteria: 1. History of other malignant tumors within 5 years prior to the first dose of study drug. Subjects who have been cured of other tumors by local therapy, such as basal cell carcinoma, squamous cell carcinoma of skin, bladder cancer in situ, cervical carcinoma in situ, or breast cancer in situ, are not excluded. 2. Patients with brainstem metastases, leptomeningeal metastases, spinal cord metastases, or spinal cord compression. 3. Patients with severe, uncontrolled cardiovascular disease. 4. Patients with concomitant pulmonary disease resulting in clinically severe impairment of respiratory function. 5. History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring corticosteroid therapy, OR current ILD or non-infectious pneumonitis. 6. Prior treatment with a B7-H3 targeted therapy (including antibodies, antibody-drug conjugates \[ADCs\], CAR-T cells, and other agents), or with a topoisomerase I inhibitor or an ADC containing a topoisomerase I inhibitor payload. 7. Prior treatment with a PD-(L)1 inhibitor (including antibodies, antibody-drug conjugates \[ADCs\], CAR-T cells, and other agents).

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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

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

  1. The study's own enquiry address

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

  2. The places running it

    20 sites. 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

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, China

  • Chongqing University Cancer Hospital

    NOT_YET_RECRUITING

    Chongqing, Chongqing Municipality, China

  • Dongguan People's Hospital

    NOT_YET_RECRUITING

    Dongguan, Guangdong, China

  • Fudan University Shanghai Cancer Center

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, China

  • Fujian Cancer Hospital

    NOT_YET_RECRUITING

    Fuzhou, Fujian, China

  • Guangxi Medical University Cancer Hospital

    NOT_YET_RECRUITING

    Nanning, Guangxi, China

  • Hunan Cancer Hospital

    NOT_YET_RECRUITING

    Changsha, Hunan, China

  • Jiangmen Central Hospital

    NOT_YET_RECRUITING

    Jiangmen, Guangdong, China

  • Jiangxi Cancer Hospital

    NOT_YET_RECRUITING

    Nanchang, Jiangxi, China

  • Sichuan Cancer Hospital

    NOT_YET_RECRUITING

    Chengdu, Sichuan, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Hainan Medical University

    NOT_YET_RECRUITING

    Haikou, Hainan, China

  • The First Affiliated Hospital of Nanchang University

    NOT_YET_RECRUITING

    Nanchang, Jiangxi, China

  • The First Affiliated Hospital of Xiamen University

    NOT_YET_RECRUITING

    Xiamen, Fujian, China

  • The Second Affiliated Hospital of Guilin Medical University

    NOT_YET_RECRUITING

    Guilin, Guangxi, China

  • Yuebei People's Hospital

    NOT_YET_RECRUITING

    Shaoguan, Guangdong, China

  • Yunnan Cancer Hospital

    NOT_YET_RECRUITING

    Kunming, Yunnan, China

  • Zhangzhou Municiple Hospital of Fujian Province

    NOT_YET_RECRUITING

    Zhangzhou, Fujian, China

  • Zhejiang Cancer Hospital

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, China

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