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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMediLink Therapeutics (Suzhou) Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Voluntarily sign a written informed consent form (ICF).

Aged ≥18 years and ≤75 years, male or female.

ECOG performance status score of 0 or 1.

Life expectancy ≥ 3 months.

Disqualifiers

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.

Previously received B7-H3-targeted drug therapy, including antibody, antibody-drug conjugate (ADC), and chimeric antigen receptor T cell (CAR-T).

Prior treatment with a topoisomerase I inhibitor or an antibody-drug conjugate containing a topoisomerase I inhibitor.

Inadequate washout period for prior anti-tumor treatment before the first dose of study drug.

Trial design

Treatments tested in this trial

  • YL201
  • Docetaxel
  • Capecitabine
  • Gemcitabine

Treatment groups

400 Participants
are divided into 2 treatment groups