drugset / Trial / NCT05824455
A Clinical Study of IMP4297 Capsule (JS109) Combined With Irinotecan in the Treatment of Advanced Malignant Solid Tumors
Phase 1/2
Terminated
4 enrolled
Shanghai Jun Pai Ying Shi Therapeutics Co., Ltd.
Sponsor GmbH · collab
NaSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2023-03-23
- Primary completion
- 2023-09-28
- Completion
- 2023-09-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | JS109 | Unknown | — | Oral |
| Background | Irinotecan | Small molecule | 65 mg/m2 | Intravenous |