Actively Recruiting
A Phase III Study of YL201 in Recurrent or Metastatic Nasopharyngeal Carcinoma
Led by MediLink Therapeutics (Suzhou) Co., Ltd. · Updated on 2025-02-10
400
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study was designed to compare the efficacy and safety of YL201 with Investigator's choice of chemotherapy in subjects with recurrent or metastatic nasopharyngeal carcinoma who have failed prior PD-(L)1 inhibitor and at least two lines of chemotherapy.
CONDITIONS
Official 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 testing
- Adequate organ function
You will not qualify if you...
- History of other malignant tumors within 5 years prior to study drug, except some cured by local therapy (e.g., basal cell carcinoma, skin squamous cell carcinoma, bladder cancer in situ, cervical carcinoma in situ, breast cancer in situ)
- Prior treatment with B7-H3-targeted therapies including antibody, ADC, or CAR-T
- Prior treatment with topoisomerase I inhibitors or ADCs containing them
- Inadequate washout period from prior anti-tumor treatment before study drug
- Received radical radiotherapy within 4 weeks before study drug; local palliative radiotherapy allowed if completed 2 weeks before and no further treatment planned
- Received systemic steroids or immunosuppressive therapy within 2 weeks before study drug
- Received live vaccine within 4 weeks before study drug or plan to receive during study
- Brain stem, meningeal, spinal cord metastases or compression
- Presence of CNS metastasis unless treated, asymptomatic, stable, and no immediate treatment needed within 2 weeks
- Uncontrolled concurrent diseases
- Severe uncontrolled cardiovascular disorders
- History or current interstitial lung disease or pneumonitis requiring corticosteroids
- Severe pulmonary disorders causing respiratory impairment
- Chronic autoimmune or inflammatory diseases requiring systemic therapy within 2 years or current systemic therapy
- Clinical symptoms requiring repeated drainage of pleural, pericardial effusion, or ascites
- Serious infections within 4 weeks before study drug
- Active pulmonary tuberculosis
- Active hepatitis B or C infection
- Unresolved toxicities from previous antitumor therapy
- Known allergy to study drug components or severe allergic reactions to similar proteins
- Pregnancy, breastfeeding, or planning pregnancy or breastfeeding during study
- Any condition or situation interfering with consent, participation, or study result interpretation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
X
Xianfeng Zhu
CONTACT
X
Xian Zhang
CONTACT
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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