CI

At a glance

ClinicalIndex Comparison Record
Phase 2Unknown· 67 target
Drug / intervention
SC0245 +1 moredrug
Likely dose
Irinotecan 80mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05731518
NCT05731518Phase 2Unknown
CompareCT.gov

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

Biocity Biopharmaceutics Co., Ltd.·interventional·Posted Feb 16, 2023·Updated Jul 14, 2023

In Brief

A Phase 2 clinical trial evaluating SC0245 and Irinotecan for Small Cell Lung Cancer. Targeting 67 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall Cell Lung Cancer
CountriesChina
Collaborators--

Timeline

Phase 2UnknownOverdue
202420252026
First PostedFeb 16, 2023
Enrollment StartFeb 23, 2023
Primary CompletionSep 30, 2025
Study CompletionFeb 28, 2026
TodayJul 1, 2026
Enrollment to primary: 2.6 yearsPosted 3.4 years ago

Interventions

SC0245drug

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.

Irinotecandrug

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.