Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06132217
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-15
First Post:
2023-11-09
Brief Title:
A Study of Simmitinib Plus SG001 in Advanced Solid Tumors
Sponsor:
Shanghai Runshi Pharmaceutical Technology Co Ltd
Organization:
Shanghai Runshi Pharmaceutical Technology Co Ltd
Study Overview
Official Title:
A Phase III Study To Evaluate The Safety Tolerability Pharmacokinetic Profile And Preliminary Efficacy Of Simmitinib Plus SG001 in Patients With Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label Phase III trial of simmitinib plus SG001 in patients with advanced solid tumors Phase I will determine and confirm the maximum tolerated dose MTD and recommended phase II dose RP2D for simmitinib in combination with SG001 in patients with advanced solid tumors Phase 2 Expansion will evaluate the safety and efficacy of the combination in 3 cohorts at the RP2D from Phase I
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None