New hope for advanced nose and throat cancer with combo therapy
NCT ID NCT07258979
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
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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 202 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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May 2028
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. 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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Genom att skicka in godkänner du våra Användarvillkor
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.
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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
20 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
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
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Affiliated Cancer Hospital and Institute of Guangzhou Medical University
NOT_YET_RECRUITINGGuangzhou, Guangdong, China
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Chongqing University Cancer Hospital
NOT_YET_RECRUITINGChongqing, Chongqing Municipality, China
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Dongguan People's Hospital
NOT_YET_RECRUITINGDongguan, Guangdong, China
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Fudan University Shanghai Cancer Center
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, China
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Fujian Cancer Hospital
NOT_YET_RECRUITINGFuzhou, Fujian, China
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Guangxi Medical University Cancer Hospital
NOT_YET_RECRUITINGNanning, Guangxi, China
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Hunan Cancer Hospital
NOT_YET_RECRUITINGChangsha, Hunan, China
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Jiangmen Central Hospital
NOT_YET_RECRUITINGJiangmen, Guangdong, China
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Jiangxi Cancer Hospital
NOT_YET_RECRUITINGNanchang, Jiangxi, China
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Sichuan Cancer Hospital
NOT_YET_RECRUITINGChengdu, Sichuan, China
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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, China
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The First Affiliated Hospital of Guangdong Pharmaceutical University
NOT_YET_RECRUITINGGuangzhou, Guangdong, China
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The First Affiliated Hospital of Hainan Medical University
NOT_YET_RECRUITINGHaikou, Hainan, China
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The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITINGNanchang, Jiangxi, China
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The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITINGXiamen, Fujian, China
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The Second Affiliated Hospital of Guilin Medical University
NOT_YET_RECRUITINGGuilin, Guangxi, China
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Yuebei People's Hospital
NOT_YET_RECRUITINGShaoguan, Guangdong, China
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Yunnan Cancer Hospital
NOT_YET_RECRUITINGKunming, Yunnan, China
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Zhangzhou Municiple Hospital of Fujian Province
NOT_YET_RECRUITINGZhangzhou, Fujian, China
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Zhejiang Cancer Hospital
NOT_YET_RECRUITINGHangzhou, Zhejiang, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New drug combo targets Hard-to-Treat nasopharyngeal cancer
- New hope for tough nasopharyngeal cancer: Triple-Drug combo trial launches
- Two-Antibody combo takes on advanced cancers
- New drug shows promise for Hard-to-Treat throat cancer
- New cocktail of drugs shows promise for Hard-to-Treat throat cancer
- New drug cocktail aims to outdo chemo for tough throat cancer