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OncoMatch/Clinical Trials/NCT06629597

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

Is NCT06629597 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including YL201 and Docetaxel for nasopharyngeal carcinoma.

Phase 3RecruitingMediLink Therapeutics (Suzhou) Co., Ltd.NCT06629597Data as of May 2026

Treatment: YL201 · Docetaxel · Capecitabine · GemcitabineThis 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.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Biomarker criteria

Required: CD276 expression testing required (testing required; no eligibility threshold specified)

Subjects are willing to provide the archived or freshly obtained tumor tissue (freshly obtained or archived) for detection of B7-H3 expression

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 2 prior lines

Must have received: PD-(L)1 inhibitor

Have failed prior treatment with PD-(L)1 inhibitors

Must have received: chemotherapy

at least two lines of chemotherapy

Cannot have received: B7-H3-targeted therapy

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

Cannot have received: topoisomerase I inhibitor

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

Lab requirements

Blood counts

Adequate organ function

Kidney function

Adequate organ function

Liver function

Adequate organ function

Adequate organ function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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