NCT06332950

Safety and Efficacy of Adebrelimab Plus Irinotecan Liposome (II) With or Without Famitinib in ES-SCLC Pre-treated With Immunotherapy

A Randomized, Multi-cohort, Multi-center Phase Ib/II Study of Adebrelimab Plus Irinotecan Liposome (II) With or Without Famitinib in Patients With ES-SCLC Pre-treated With Immune Checkpoint Inhibitor(s)

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Baohui Han · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, randomized, multi-cohort, multi-center, phase Ib/II study to evaluate the safety and efficacy of Adebrelimab plus Irinotecan Liposome (II) with or without Famitinib in patients with extensive-stage small cell lung cancer (ES-SCLC) pre-treated with immune checkpoint inhibitor(s).

Detailed description

This study is divided into two stages. Dose exploration will be conducted first, and after obtaining preliminary safety data it will be decided by investigator when to proceed with dose extension. The aim of this study is to observe and evaluate the safety and efficacy of Adebrelimab plus Irinotecan Liposome (II) with or without Famitinib.

Conditions

• Extensive-stage Small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Adebrelimab, Irinotecan Liposome (II)	Adebrelimab:1200 mg, IV, D1, Q3W Irinotecan Liposome (II): RP2D, IV, D1, Q3W Escalating doses to determine recommended phase 2 dose (RP2D) of Irinotecan Liposome (II). Participants will receive Adebrelimab (1200 mg, IV, D1, Q3W) plus the RP2D of Irinotecan Liposome (II).
DRUG	Adebrelimab, Irinotecan Liposome (II), Famitinib	Adebrelimab:1200 mg, IV, D1, Q3W Irinotecan Liposome (II): RP2D, IV, D1, Q3W Famitinib: RP2D, QO, QD Escalating doses to determine recommended phase 2 dose (RP2D) of Famitinib. Participants will receive Adebrelimab (1200 mg, IV, D1, Q3W) plus the RP2D of Irinotecan Liposome (II) and Famitinib.

Timeline

• Start date: 2024-04-01
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2024-03-27
• Last updated: 2024-03-27

Locations

1 site across 1 country: China