Comparing YL201 to standard chemotherapy for advanced nasopharyngeal carcinoma

A Randomized, Controlled, Multicenter Phase III Clinical Study of YL201 Versus 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

This study is testing if a new treatment called YL201 can help people with advanced nasopharyngeal cancer live longer and feel better compared to standard chemotherapy after their previous treatments didn't work.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. (Industry-sponsored)
• Drugs / interventions: CAR-T, chimeric antigen receptor, chemotherapy, radiation
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06629597 on ClinicalTrials.gov

What this trial studies

This Phase III study evaluates the efficacy and safety of YL201 in patients with recurrent or metastatic nasopharyngeal carcinoma who have previously failed PD-(L)1 inhibitors and at least two lines of chemotherapy. The primary goal is to determine if YL201 can prolong overall survival and improve the objective response rate compared to the investigator's choice of chemotherapy. Secondary objectives include assessing the drug's safety, pharmacokinetics, immunogenicity, and the relationship between B7-H3 expression levels and treatment efficacy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with recurrent or metastatic nasopharyngeal carcinoma who have failed prior treatments.

Not a fit: Patients with other active malignancies or those who have not failed prior PD-(L)1 inhibitors and two lines of chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced nasopharyngeal carcinoma who have limited treatment choices.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in targeting advanced cancers with novel therapies.

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. Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma that is not amenable to curative treatment.
6. Have failed prior treatment with PD-(L)1 inhibitors and at least two lines of chemotherapy.
7. Suitable for treatment with investigator's choice of chemotherapy (docetaxel, capecitabine, or gemcitabine).
8. At least one measurable lesion according to RECIST v1.1.
9. Subjects are willing to provide the archived or freshly obtained tumor tissue (freshly obtained or archived) for detection of B7-H3 expression
10. 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. Previously received B7-H3-targeted drug therapy, including antibody, antibody-drug conjugate (ADC), and chimeric antigen receptor T cell (CAR-T).
3. Prior treatment with a topoisomerase I inhibitor or an antibody-drug conjugate containing a topoisomerase I inhibitor.
4. Inadequate washout period for prior anti-tumor treatment before the first dose of study drug.
5. Received radical radiotherapy within 4 weeks prior to the first dose of study drug; local palliative radiation for symptom control is allowed, but treatment must be completed at least 2 weeks prior to the first dose of study drug, and there is no plan for additional radiotherapy to the same lesion.
6. Received systemic steroids or other immunosuppressive therapy within 2 weeks before the first dose of study drug.
7. Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study.
8. Presence of brain stem or meningeal metastases, spinal cord metastases or compression.
9. Presence of central nervous system (CNS) metastasis. Participants with treated brain metastases are eligible if the metastases are asymptomatic and stable, and no immediate local or systemic treatment is needed within 2 weeks before the first dose.
10. Has an uncontrolled concurrent disease.
11. Presence of severe uncontrolled cardiovascular disorder.
12. History of interstitial lung disease (ILD) or pneumonitis that required corticosteroids, or current ILD/ pneumonitis.
13. Concomitant pulmonary disorder leading to clinically severe respiratory impairment.
14. Chronic autoimmune or inflammatory diseases requiring systemic therapy within 2 years prior to the first dose or currently receiving systemic therapy.
15. Clinical symptoms of pleural effusion, pericardial effusion, or ascites or requiring relevant repeated drainage.
16. Serious infections within 4 weeks prior to the first dose.
17. Known active pulmonary tuberculosis (TB).
18. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
19. Unresolved toxicities from previous antitumor therapy.
20. Known allergy to any component of the study drug; history of severe allergic reactions or known history of severe hypersensitivity to other monoclonal antibodies or recombinant proteins, or history of severe infusion reactions.
21. Pregnancy, breastfeeding, or women planning to become pregnant or breastfeed during the study.
22. Any illness, medical condition, organ system dysfunction, or social situation deemed by the investigator to be likely to interfere with a subject's ability to sign ICF, adversely affect the subject's ability to cooperate and participate in the study, or compromise the interpretation of study results.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Xianfeng Zhu

Conditions Nasopharyngeal Carcinoma