At a glance
ClinicalIndex Comparison RecordPhase 2Terminated· 4 enrolled
Drug / intervention
JS109 combine with irinotecancombination
Likely dose
JS109 combine with irinotecan 65mg/m2from 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.
An Open, Multicenter, Phase Ib/II Clinical Study of IMP4297 Capsule (JS109) Combined With Irinotecan in the Treatment of Advanced Malignant Solid Tumors
Shanghai Jun Pai Ying Shi Therapeutics Co., Ltd.·interventional·Posted Apr 21, 2023·Updated Sep 5, 2024
In Brief
A Phase 2 clinical trial evaluating JS109 combine with irinotecan for Advanced Solid Tumors. Terminated early, enrolled 4 participants across 1 site.
Signals
Trial was terminated early
Detailed Summary
The Phase Ib study was designed to evaluate the safety of JS109 in combination with irinotecan in the treatment of advanced solid tumors and to determine the Phase II recommended dose (RP2D). The Phase II study was designed to evaluate the efficacy and safety of the combination regimen in patients with extensive small-cell lung cancer (SCLC) that failed first-line platinum-containing regimen.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumors
CountriesChina
CollaboratorsSponsor GmbH
Timeline
Phase 2TerminatedFinished
202420252026
Enrollment StartMar 2023
First PostedApr 2023
Primary CompletionSep 2023
TodayJul 2026
First PostedApr 21, 2023
Enrollment StartMar 23, 2023
Primary CompletionSep 28, 2023
TodayJul 1, 2026
Enrollment to primary: 6 monthsPosted 3.2 years ago
Interventions
JS109 combine with irinotecancombination
JS109 PO,QD, q3w combine with irinotecan(65mg/m2,IV,D1,8,Q3w)