Phase II Study of SI-B003 Alone and Combined with BL-B01D1 in Treating Patients with Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma, and Other Solid Tumors

What this Trial Is About

Researchers are evaluating the combination of BL-B01D1 and SI-B003 in patients with locally advanced or metastatic non-small cell lung cancer, nasopharyngeal carcinoma, and other solid tumors. This Phase II study aims to explore how well this combination works, its safety, tolerability, and to determine the best dose and method for using these treatments together. The study focuses on patients with measurable tumors and specific health conditions suitable for this therapy. Participants receive both SI-B003 and the combination of BL-B01D1 with SI-B003 through intravenous infusions during the first 3-week treatment cycle. Those who show clinical benefits may continue to receive additional treatment cycles. Treatment will be stopped if the disease worsens, side effects become intolerable, or for other reasons determined by the study. During the study, participants will be closely monitored for tumor response, side effects, and overall disease control using specific criteria like tumor size changes. Assessments include imaging and safety evaluations conducted up to approximately 24 months. Researchers will measure outcomes such as objective response rate, progression-free survival, treatment-related adverse events, and determine the recommended dose for future studies. Participants health and safety are carefully observed throughout the trial period.

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