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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT05956587 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, biological therapy, mitomycin disqualifies patients from enrollment.
Are patients with MET alterations eligible?
No. MET exon 14 skipping is an exclusion criterion.
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.
Check if I qualify