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OncoMatch/Clinical Trials/NCT05956587

A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors

Is NCT05956587 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including BL-B01D1 and SI-B003 for non-small cell lung cancer.

Phase 2RecruitingSichuan Baili Pharmaceutical Co., Ltd.NCT05956587Data as of May 2026

Treatment: BL-B01D1 · SI-B003Phase II: To explore the efficacy, safety and tolerability of BL-B01D1+SI-B003 in patients with locally advanced or metastatic non-small cell lung cancer and nasopharyngeal carcinoma, and to further explore the optimal dose and mode of combination.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Head and Neck Squamous Cell Carcinoma

Biomarker criteria

Excluded: MET exon 14 skipping

patients with MET 14 exon skipping detected by gene sequencing report before signing informed consent [excluded for stage 3 Cohort_A]

Disease stage

Metastatic disease required

locally advanced or metastatic solid tumors

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: chemotherapy

Chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose

Cannot have received: biological therapy

Chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose

Cannot have received: mitomycin (mitomycin)

Mitomycin and nitrosoureas were administered within 6 weeks before the first dose

Cannot have received: nitrosourea (nitrosoureas)

Mitomycin and nitrosoureas were administered within 6 weeks before the first dose

Cannot have received: oral antimetabolite (fluorouracil)

Oral drugs such as fluorouracil

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: immunomodulatory drug

Use of immunomodulatory drugs within 14 days before the first dose of study drug

Lab requirements

Cardiac function

No severe cardiac dysfunction, left ventricular ejection fraction ≥50%

No severe cardiac dysfunction, left ventricular ejection fraction ≥50%

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

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