A Study of DXC006 With Immune Checkpoint Inhibitors or Platinum for Small Cell Lung Cancer.

Registry record from ClinicalTrials.gov (NCT07559929). This is a study registration, not published results. Lead sponsor: Hangzhou DAC Biotechnology Co., Ltd.. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 200 participants (ESTIMATED). Conditions: Small Cell Lung Cancer. Interventions: DRUG: DXC006; DRUG: Toripalimab; DRUG: Carboplatin; DRUG: Cisplatin. Primary outcome measures: Progression Free Survival (PFS) , From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.; 6-month progression-free survival rate , From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.; Recommended Phase 2 Dose (RP2D) , Final RP2D confirmation upon completion of the Phase Ib (up to 12 months).; Measurement of objective response rate (ORR) per RECIST 1.1 , From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.; Measurement of disease control rate (DCR) , From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.; Incidence of Adverse Events (AEs) , After first infusion of study drug, through study completion an average of 2 year.. Brief summary: This is a Phase Ib/II, open-label clinical study designed to evaluate the safety, tolerability, preliminary anti-tumor activity, recommended Phase 2 dose (RP2D), pharmacokinetic (PK) characteristics, and immunogenicity of DXC006 in combination with an immune checkpoint inhibitor (ICI) or platinum-based chemotherapy in patients with small cell lung cancer (SCLC).