YL201 with toripalimab, with or without cisplatin, for recurrent or metastatic nasopharyngeal carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open‑label Phase Ib/II trial in China testing the safety, efficacy, and pharmacokinetics of YL201 combined with the PD‑1 inhibitor toripalimab, given either alone (doublet) or with cisplatin (triplet). Phase Ib will primarily address safety and dosing while Phase II will expand to measure anti‑tumor activity. Eligible participants are adults with histologically confirmed recurrent or metastatic nasopharyngeal carcinoma not amenable to curative treatment, generally treatment‑naïve in the metastatic setting, with measurable disease and ECOG 0–1. Treatments are given at participating hospitals with regular tumor assessments by RECIST v1.1 and laboratory monitoring.

Why it matters

Who can join: the full rules

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).

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Chongqing University Cancer Hospital
  Chongqing, Chongqing Municipality, China Not yet recruiting
• Fujian Cancer Hospital
  Fuzhou, Fujian, China Not yet recruiting
• The First Affiliated Hospital of Xiamen University
  Xiamen, Fujian, China Not yet recruiting
• Zhangzhou Municiple Hospital of Fujian Province
  Zhangzhou, Fujian, China Not yet recruiting
• Dongguan People's Hospital
  Dongguan, Guangdong, China Not yet recruiting

Study contacts

• Study coordinator: MediLink Study Team
• Email: clinicaltrials@medilinkthera.com
• Phone: +86 512 62858368

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.