NCT05731518

SC0245 and Irinotecan in Treating Patients With Relapsed Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

A Phase Ib/II , Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Effects of SC0245 in Combination With Irinotecan in Patients With ES-SCLC

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: Biocity Biopharmaceutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single arm, multi-center, open label phase Ib/II study of SC0245 and Irinotecan combination therapy in subjects with extensive-stage small cell lung cancer (ES-SCLC) as a second therapy. This study will have three parts, phase 1 dose escalation (Part 1), phase 1 dose expansion (Part 2), and phase 2 combination therapy (Part 3).

Detailed description

This study will have three parts, phase 1 dose escalation (Part 1), phase 1 dose expansion (Part 2)， and phase 2 combination therapy (Part 3). Subjects will receive SC0245 and Irinotecan combination therapy. The study is composed of 67 subjects. Irinotecan 80mg/m2 via IV administered for every 4 weeks (fixed dosing) in Day 1 Day8 and Day 15 of each cycle, and SC0245 administered with a 3-day on and 4-day off schedule in Day 1 Day8 and Day 15 of each cycle. One cycle is consisted of 28 days. Study treatment will be continued until objective disease progression (unless other criteria for treatment discontinuation are met). Tumor evaluation using CT or MRI by RECIST 1.1 every 8weeks(±1week) until objective disease progression. RECIST 1.1 scans will be analyzed by the investigator on site. If a subject discontinues study treatment prior to disease progression, they should continue to be assessed using RECIST 1.1 until disease progression and then followed up for survival. Primary Objective: Part 1 (phase 1 dose escalation): To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SC0245 in combination with irinotecan in patients with advanced solid tumors. Part 2 (phase 1 dose expansion): To evaluate the safety and tolerability of SC0245 in combination with irinotecan in patients with relapsed extensive-stage small cell lung cancer (ES-SCLC). Part 3(phase 2 combination therapy): To evaluate the preliminary anti-tumor activity of SC0245 in combination with irinotecan in patients with relapsed extensive-stage small cell lung cancer (ES-SCLC). Secondary Objective: Part 1 (phase 1 dose escalation): To characterize the PK profile and the preliminary anti-tumor activity. Part 2 (phase 1 dose expansion): To characterize the PK profile, safety and tolerability and the preliminary anti-tumor activity in patients with relapsed extensive-stage small cell lung cancer (ES-SCLC). Part 3(phase 2 combination therapy): To characterize the safety and tolerability and the preliminary anti-tumor activity in patients with relapsed extensive-stage small cell lung cancer (ES-SCLC).

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	SC0245	SC0245 Quaque Die(QD) administered with a 3-day on and 4-day off schedule in Day 1 Day8 and Day 15 of each cycle. One cycle is consisted of 28 days.
DRUG	Irinotecan	Irinotecan 80mg/m\^2 via IV administered for every 4 weeks (fixed dosing) in Day 1 Day8 and Day 15 of each cycle. One cycle is consisted of 28 days.

Timeline

• Start date: 2023-02-23
• Primary completion: 2025-09-30
• Completion: 2026-02-28
• First posted: 2023-02-16
• Last updated: 2023-07-14

Locations

1 site across 1 country: China