Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06238687
Status:
RECRUITING
Last Update Posted:
2024-02-02
First Post:
2023-11-21
Brief Title:
A Study of STRO-002 in Chinese Adults With Epithelial Ovarian Cancer and Other Advanced Malignant Solid Tumors
Sponsor:
Tasly Pharmaceutical Group Co Ltd
Organization:
Tasly Pharmaceutical Group Co Ltd
Study Overview
Official Title:
A Phase IIIa Study to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Efficacy of STRO-002 in Chinese Adults With Advanced Epithelial Ovarian Cancer Endometrial Cancer and Other Advanced Malignant Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-02
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 a multi-center open-label monotherapy dose escalation PK bridging and dose expansion Phase IIIa study in Chinese adult subjects to evaluate the safety tolerability Pharmacokinetics PK profiles immunogenicity and preliminary efficacy of STRO-002 in patients with advanced malignant solid tumors
Detailed Description:
This study consists of two parts Phase I dose escalation and PK bridging and Phase IIa dose expansion Subjects in each cohort of Phase I will be administered 3 scheduled dose levels of STRO-002 as monotherapy by intravenous infusion until intolerable toxicity radiographic disease progression or subject withdrawal for other reasons 5 dose arms are tentatively set based on the available safety PK and efficacy data of STRO-002 for the Phase IIa dose expansion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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