NCT07258979 A Study of YL201 in Combination With Toripalimab and With or Without Cisplatin in Nasopharyngeal Carcinoma.
| NCT ID | NCT07258979 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | MediLink Therapeutics (Suzhou) Co., Ltd. |
| Condition | Recurrent or Metastatic Nasopharyngeal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 202 participants |
| Start Date | 2025-11-05 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 202 participants in total. It began in 2025-11-05 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a multicenter, open-label, Phase Ib/II study conducted in China to evaluate the safety, efficacy, and pharmacokinetic (PK) characteristics of YL201 combined with Toripalimab (doublet regimen) or YL201 combined with Toripalimab and Cisplatin (triplet regimen) in subjects with recurrent or metastatic nasopharyngeal carcinoma.
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07258979 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Recurrent or Metastatic Nasopharyngeal Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07258979 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07258979 currently recruiting?
Yes, NCT07258979 is actively recruiting participants. Contact the research team at clinicaltrials@medilinkthera.com for enrollment information.
Where is the NCT07258979 trial being conducted?
This trial is being conducted at Chongqing, China, Fuzhou, China, Xiamen, China, Zhangzhou, China and 11 additional locations.
Who is sponsoring the NCT07258979 clinical trial?
NCT07258979 is sponsored by MediLink Therapeutics (Suzhou) Co., Ltd.. The trial plans to enroll 202 participants.