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OncoMatch/Clinical Trials/NCT07258979

A Study of YL201 in Combination With Toripalimab and With or Without Cisplatin in Nasopharyngeal Carcinoma.

Is NCT07258979 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including YL201 and Toripalimab for recurrent or metastatic nasopharyngeal carcinoma.

Phase 1/2RecruitingMediLink Therapeutics (Suzhou) Co., Ltd.NCT07258979Data as of Jun 2026Location: China

Treatment: YL201 · Toripalimab · CisplatinThis is a multicenter, open-label, Phase Ib/II study conducted in China to evaluate the safety, efficacy, and pharmacokinetic (PK) characteristics of YL201 combined with Toripalimab (doublet regimen) or YL201 combined with Toripalimab and Cisplatin (triplet regimen) in subjects with recurrent or metastatic nasopharyngeal carcinoma.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Toripalimab

Chemotherapy

Cisplatin

Other

YL201

Cancer type

Head and Neck Squamous Cell Carcinoma

Disease stage

Required: Stage IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: B7-H3 targeted therapy

Prior treatment with a B7-H3 targeted therapy (including antibodies, antibody-drug conjugates [ADCs], CAR-T cells, and other agents)

Cannot have received: topoisomerase I inhibitor

Prior treatment with a topoisomerase I inhibitor or an ADC containing a topoisomerase I inhibitor payload

Cannot have received: PD-(L)1 inhibitor

Prior treatment with a PD-(L)1 inhibitor (including antibodies, antibody-drug conjugates [ADCs], CAR-T cells, and other agents)

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 NCT07258979 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

What disease stage is eligible?

Stage IV is required.

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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