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OncoMatch/Clinical Trials/NCT06437522

A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

Is NCT06437522 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including BL-B01D1 and PD-1 monoclonal antibody for head and neck squamous cell carcinoma.

Phase 2RecruitingSichuan Baili Pharmaceutical Co., Ltd.NCT06437522Data as of May 2026

Treatment: BL-B01D1 · PD-1 monoclonal antibodyThis study is a phase II clinical study to explore the efficacy and safety of BL-B01D1 + PD-1 monoclonal antibody combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) and other solid tumors.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Biomarker criteria

Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: antibody-drug conjugate

Exception: with TOP I inhibitors as a toxin

Prior treatment with an ADC drug with TOP I inhibitors as a toxin

Cannot have received: systemic antitumor regimen

Received any previous systemic antitumor regimen for solid tumors such as recurrent or metastatic head and neck squamous cell carcinoma

Cannot have received: immunotherapy

Exception: if developed ≥ grade 3 irAE or ≥ grade 2 immune-related myocarditis

Had received immunotherapy and developed ≥ grade 3 irAE or ≥ grade 2 immune-related myocarditis

Cannot have received: anti-tumor treatment

Exception: within four weeks or five half-life before first delivery

Before the first delivery within four weeks or five half-life used anti-tumor treatment

Cannot have received: palliative radiotherapy

Exception: within 2 weeks before the first dose

Palliative radiotherapy was given within 2 weeks before the first dose

Lab requirements

Blood counts

the organ function level must meet the requirements

Kidney function

the organ function level must meet the requirements

Liver function

the organ function level must meet the requirements

the organ function level must meet the requirements

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

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