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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 (Jun 2026). This Phase 3 trial studies multiple treatments including YL201 and Docetaxel for nasopharyngeal carcinoma.

Phase 3RecruitingMediLink Therapeutics (Suzhou) Co., Ltd.NCT06629597Data as of Jun 2026Location: China

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

Treatments studied

Chemotherapy

DocetaxelCapecitabineGemcitabine

Other

YL201

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)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT06629597 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior B7-H3-targeted therapy, topoisomerase I inhibitor disqualifies patients from enrollment.

Does this trial require CD276?

Yes, CD276 expression testing required is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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