Actively Recruiting
A Randomized Phase III Study of YL201 Versus Investigator's Choice of Chemotherapy in Recurrent or Metastatic Nasopharyngeal Carcinoma After Prior PD-(L)1 Inhibitor and Chemotherapy
Led by MediLink Therapeutics (Suzhou) Co., Ltd. · Updated on 2025-02-10
400
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of YL201 compared to the investigator's choice of chemotherapy in adults with recurrent or metastatic nasopharyngeal carcinoma who have previously been treated with PD-(L)1 inhibitors and at least two chemotherapy regimens. The study aims to see if YL201 can improve overall survival and increase tumor response rates, while also exploring its safety profile, drug behavior in the body, immune response, and the relationship between a specific tumor marker (B7-H3) and treatment outcomes. Participants are randomly assigned to one of two treatment groups. One group receives YL201 intravenously on the first day of every 3-week cycle at a recommended dose, continuing until the cancer worsens, side effects become unacceptable, or the participant chooses to stop. The other group receives one of three chemotherapy drugs—docetaxel, capecitabine, or gemcitabine—administered according to standard dosing schedules every 3 weeks, also until disease progression, unacceptable side effects, or withdrawal. During the study, participants undergo regular evaluations including tumor scans assessed by independent reviewers and investigators to measure response rates and survival. Safety is monitored by tracking side effects, and blood samples are collected to study drug levels and immune responses. Tumor tissue is examined to measure B7-H3 expression. The main outcomes, such as tumor response and survival, are expected to be assessed approximately within 36 months, with continuous monitoring to ensure participant safety and treatment adherence throughout the study.
CONDITIONS
Brief Title
A Phase III Study of YL201 in Recurrent or Metastatic Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign a written informed consent form
- Aged 18 to 75 years, male or female
- ECOG performance status score of 0 or 1
- Life expectancy of at least 3 months
- Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma not suitable for curative treatment
- Failed prior treatment with PD-(L)1 inhibitors and at least two lines of chemotherapy
- Suitable for treatment with investigator's choice of chemotherapy (docetaxel, capecitabine, or gemcitabine)
- At least one measurable lesion according to RECIST v1.1
- Willing to provide archived or freshly obtained tumor tissue for B7-H3 expression detection
- Adequate organ function
You will not qualify if you...
- History of other malignant tumors within 5 years before first dose, except certain cured local cancers
- Prior treatment with B7-H3-targeted therapies including antibody, ADC, or CAR-T
- Prior treatment with topoisomerase I inhibitors or ADC containing topoisomerase I inhibitors
- Inadequate washout period from prior anti-tumor treatments before first dose
- Received radical radiotherapy within 4 weeks or local palliative radiation within 2 weeks before first dose
- Received systemic steroids or immunosuppressive therapy within 2 weeks before first dose
- Received any live vaccine within 4 weeks before first dose or intend to during the study
- Presence of brain stem, meningeal, spinal cord metastases or compression
- Presence of central nervous system metastasis unless treated and stable without recent treatment
- Uncontrolled concurrent disease
- Severe uncontrolled cardiovascular disorder
- History or current interstitial lung disease or pneumonitis requiring steroids
- Severe respiratory impairment due to pulmonary disorder
- Chronic autoimmune or inflammatory diseases requiring systemic therapy within 2 years or currently treated
- Symptoms of pleural, pericardial effusion, or ascites requiring repeated drainage
- Serious infections within 4 weeks before first dose
- Active pulmonary tuberculosis or hepatitis B or C infection
- Unresolved toxicities from previous antitumor therapy
- Known allergy or severe reactions to study drug components or similar proteins
- Pregnancy, breastfeeding, or planning pregnancy or breastfeeding during the study
- Any illness or condition that may interfere with consent, participation, or study results interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 36 months
Participants receive either YL201 monotherapy intravenously on Day 1 of each 3-week cycle or investigator's choice of chemotherapy (docetaxel, capecitabine, or gemcitabine) every 3 weeks. Treatment continues until disease progression, unacceptable toxicity, or withdrawal of consent.
Visits every 3 weeks for treatment administration
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
X
Xianfeng Zhu
X
Xian Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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