A Phase III Study of YL201 in Recurrent or Metastatic Nasopharyngeal Carcinoma

Trial Title: A Phase III Study of YL201 in Recurrent or Metastatic Nasopharyngeal Carcinoma

NCT ID: NCT06629597

Condition: Nasopharyngeal Carcinoma

Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Gemcitabine
Capecitabine
Docetaxel

Study type: Interventional

Study phase: Phase 3

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: YL201
Description: YL201 will be administered intravenously on Day 1 of each 3-week cycle at RP3D dose level.
Arm group label: YL201

Intervention type: Drug
Intervention name: Docetaxel
Description: Docetaxel will be administered intravenously at 75 mg/m2 on Day 1 of each 3-week cycle.
Arm group label: Investigator's choice of chemotherapy, including docetaxel, capecitabine, or gemcitabine

Intervention type: Drug
Intervention name: Capecitabine
Description: Capecitabine will be administered orally at 1000 mg/m2 twice a day (BID) on Days 1 to 14 of each 3-week cycle
Arm group label: Investigator's choice of chemotherapy, including docetaxel, capecitabine, or gemcitabine

Intervention type: Drug
Intervention name: Gemcitabine
Description: Gemcitabine will be administered intravenously at 1000 mg/m2 on Day 1 and 8 of each 3-week cycle
Arm group label: Investigator's choice of chemotherapy, including docetaxel, capecitabine, or gemcitabine

Summary: 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.

Detailed description: The primary objective of this study is to assess whether treatment with YL201 prolongs overall survival (OS) and increases objective response rate (ORR) by blinded independent central review (BICR) compared with treatment of investigator's choice of chemotherapy among subjects with recurrent or metastatic nasopharyngeal carcinoma. The secondary objectives of the study are to further evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of YL201, and the correlation between B7-H3 expression level and the efficacy of YL201.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Sun Yat-sen University Cancer Center

Address:
City: Guangzhou
Zip: 510000
Country: China

Contact:
Last name: Site Coordinator

Start date: December 1, 2024

Completion date: December 1, 2028

Lead sponsor:
Agency: MediLink Therapeutics (Suzhou) Co., Ltd.
Agency class: Industry

Source: MediLink Therapeutics (Suzhou) Co., Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06629597