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.
Treatment: BL-B01D1 · SI-B003 — Phase 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.
Check if I qualifyExtracted 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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