Ignite Creation Date:
2024-07-17 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487559
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-28
Brief Title:
A Study to Assess the Adverse Events and How Intravenously Infused Livmoniplimab in Combination With Budigalimab Moves Through the Bodies of Adult Chinese Participants With Locally Advanced or Metastatic Hepatocellular Carcinoma HCC
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Phase 1b Study to Evaluate the Safety and Pharmacokinetics of Livmoniplimab in Combination With Budigalimab in Chinese Subjects With Locally Advanced or Metastatic Child-Pugh A Hepatocellular Carcinoma Who Have Progressed After a First-Line Regimen That Includes an Immune Checkpoint Inhibitor
Status:
RECRUITING
Status Verified Date:
2024-10
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:
Hepatocellular carcinoma HCC is a common cancer worldwide and a leading cause of cancer-related death The majority of participants first presenting with HCC have advanced unresectable or metastatic disease The purpose of this study is to assess adverse events and how livmoniplimab in combination with budigalimab moves through the body in adult Chinese participants with Locally Advanced or metastatic Child-Pugh A Hepatocellular Carcinoma HCC
Livmoniplimab is an investigational drug being developed for the treatment of HCC There are 2 stages to this study Stage 1 is a safety run-in There are 2 treatment arms in stage 1 and participants will receive escalating doses of Livmoniplimab in combination with budigalimab fixed dose Stage 2 is dose expansion There are 2 treatment arms in stage 2 and participants will receive Livmoniplimab in combination with budigalimab in multiple doses Approximately 20 adult participants will be enrolled in the study across 15 sites in China
In part 1 dose escalation participants will be intravenously infused with escalating doses of livmoniplimab in combination with budigalimab every 3 weeks In part 2 dose expansion participants will be intravenously infused with livmoniplimab in combination with budigalimab in multiple doses every 3 weeks The estimated duration of the study is up to 2 years
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments blood tests and scans
Livmoniplimab is an investigational drug being developed for the treatment of HCC There are 2 stages to this study Stage 1 is a safety run-in There are 2 treatment arms in stage 1 and participants will receive escalating doses of Livmoniplimab in combination with budigalimab fixed dose Stage 2 is dose expansion There are 2 treatment arms in stage 2 and participants will receive Livmoniplimab in combination with budigalimab in multiple doses Approximately 20 adult participants will be enrolled in the study across 15 sites in China
In part 1 dose escalation participants will be intravenously infused with escalating doses of livmoniplimab in combination with budigalimab every 3 weeks In part 2 dose expansion participants will be intravenously infused with livmoniplimab in combination with budigalimab in multiple doses every 3 weeks The estimated duration of the study is up to 2 years
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments blood tests and scans
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?:
False
Is an FDA AA801 Violation?:
None