Trials / Terminated
TerminatedNCT05824455
A Clinical Study of IMP4297 Capsule (JS109) Combined With Irinotecan in the Treatment of Advanced Malignant Solid Tumors
An Open, Multicenter, Phase Ib/II Clinical Study of IMP4297 Capsule (JS109) Combined With Irinotecan in the Treatment of Advanced Malignant Solid Tumors
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Shanghai Jun Pai Ying Shi Therapeutics Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | JS109 combine with irinotecan | JS109 PO,QD, q3w combine with irinotecan(65mg/m2,IV,D1,8,Q3w) |
Timeline
- Start date
- 2023-03-23
- Primary completion
- 2023-09-28
- Completion
- 2023-09-28
- First posted
- 2023-04-21
- Last updated
- 2024-09-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05824455. Inclusion in this directory is not an endorsement.