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

A Multicenter, Open-label, Phase Ib/II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 Combined With Toripalimab, With or Without Cisplatin, in Subjects With Recurrent or Metastatic Nasopharyngeal Carcinoma.

This trial tests whether adding the experimental drug YL201 to toripalimab, with or without cisplatin, can help people with recurrent or metastatic nasopharyngeal carcinoma.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 202 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. (industry)
• Drugs / interventions: CAR-T, Toripalimab
• Locations: 20 sites (Chongqing, Chongqing Municipality and 19 other locations)
• Trial ID: NCT07258979 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–75 with histologically confirmed recurrent or metastatic nasopharyngeal carcinoma not curable by local therapy, ECOG 0–1, measurable disease, systemic treatment–naïve, and adequate organ function.

Not a fit: Patients who have already received systemic therapy for metastatic disease, have poor performance status (ECOG >1), inadequate organ function, or recent other malignancies are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the combination may increase tumor response rates and delay disease progression compared with current options.

How similar studies have performed: PD‑1 inhibitors such as toripalimab have shown benefit in nasopharyngeal carcinoma and chemo‑immunotherapy combinations have improved outcomes, but adding the novel agent YL201 is unproven.

Eligibility criteria

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 this trial is running

Chongqing, Chongqing Municipality and 19 other locations

• 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)
• Affiliated Cancer Hospital and Institute of Guangzhou Medical University — Guangzhou, Guangdong, China (NOT_YET_RECRUITING)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)
• The First Affiliated Hospital of Guangdong Pharmaceutical University — Guangzhou, Guangdong, China (NOT_YET_RECRUITING)
• Jiangmen Central Hospital — Jiangmen, Guangdong, China (NOT_YET_RECRUITING)
• Yuebei People's Hospital — Shaoguan, Guangdong, China (NOT_YET_RECRUITING)
• The Second Affiliated Hospital of Guilin Medical University — Guilin, Guangxi, China (NOT_YET_RECRUITING)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Hainan Medical University — Haikou, Hainan, China (NOT_YET_RECRUITING)
• Hunan Cancer Hospital — Changsha, Hunan, China (NOT_YET_RECRUITING)
• Jiangxi Cancer Hospital — Nanchang, Jiangxi, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (NOT_YET_RECRUITING)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (NOT_YET_RECRUITING)
• Sichuan Cancer Hospital — Chengdu, Sichuan, China (NOT_YET_RECRUITING)
• Yunnan Cancer Hospital — Kunming, Yunnan, China (NOT_YET_RECRUITING)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: MediLink Study Team

Conditions: Recurrent or Metastatic Nasopharyngeal Carcinoma, YL201, recurrent or metastatic nasopharyngeal carcinoma, Toripalimab