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
Recruiting · Phase 2 · Sichuan Baili Pharmaceutical Co., Ltd. · registry updated 2025-09-26
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- Sign the informed consent form voluntarily and follow the protocol requirements;
- Gender is not limited;
- Age: ≥18 years old and ≤75 years old;
- Expected survival time ≥3 months;
- Patients with histologically and/or cytologically confirmed locally advanced or metastatic solid tumors such as non-small cell lung cancer and nasopharyngeal carcinoma;
- Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 2 years;
Exclusion
- For stage 3 Cohort\_A, patients with MET 14 exon skipping detected by gene sequencing report before signing informed consent;
- Chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral drugs such as fluorouracil;
- Had received immunotherapy and developed ≥ grade 3 irAE or ≥ grade 2 immune-related myocarditis;
- Use of immunomodulatory drugs within 14 days before the first dose of study drug;
- History of severe heart disease;
- QT prolongation, complete left bundle branch block, III degree atrioventricular block;