Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584071
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
A Study to Evaluate of PM8002 Combined With PM1009 in Patients With First-line HCC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase IbII Clinical Trial to Evaluate the Preliminary Efficacy Safety and Pharmacokinetics of PM8002 Injection Combined With PM1009 Injection in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study to evaluate the preliminary efficacy safety and pharmacokinetics of PM8002 combined with PM1009 in Patients with first-line Hepatocellular Carcinoma
Detailed Description:
The study is divided into two parts The first part is a phase Ib single-arm study which is planned to enroll 3-28 subjects
The second part is a phase II randomized parallel-controlled four-arm open-label study which is planned to enroll approximately 120 subjects
The second part is a phase II randomized parallel-controlled four-arm open-label study which is planned to enroll approximately 120 subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None