Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06055348
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-26
First Post:
2023-08-15
Brief Title:
SC0191 Plus Chemotherapy in Advanced Ovarian Canceradvanced Ovarian Cancer
Sponsor:
Biocity Biopharmaceutics Co Ltd
Organization:
Biocity Biopharmaceutics Co Ltd
Study Overview
Official Title:
A Phase IbII Clinical Study on the Safety Pharmacokinetic Characteristics and Preliminary Efficacy of SC0191 Combination Chemotherapy in Patients With Advanced Ovarian Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
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:
A phase IbII clinical study on the safety pharmacokinetic characteristics and preliminary efficacy of SC0191 combination chemotherapy in patients with advanced ovarian cancer
Detailed Description:
The phase 1b2multicenter open-label study contains 2 parts
Part 1 Dose Escalation of SC0191 combination chemotherapy
Part 1 will estimate the RP2D in dose escalation cohorts in patients withadvanced ovarian cancer
Part 2 Dose Expansion of SC0191 plus Chemotherapy
Part 1 Dose Escalation of SC0191 combination chemotherapy
Part 1 will estimate the RP2D in dose escalation cohorts in patients withadvanced ovarian cancer
Part 2 Dose Expansion of SC0191 plus Chemotherapy
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