Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06530251
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-28
Brief Title:
A Study of AK112 in Patients With Advanced Hepatocellular Carcinoma HCC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase IbII Study of AK112 in Combination Therapy for Patients With Advanced Hepatocellular Carcinoma HCC
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:
Therere 2 parts in this interventional study
1 The goal of phase Ib trial is to evaluate the safety and tolerability of AK112 in combination therapies for the purpose of observing the incidence of dose limit toxicity DLT as well as the confirmation of maximum tolerable dose MTD in the treatment of advanced hepatocellular carcinoma HCC so as to determine the recommended phase 2 dose RP2D in the second part of the trial
2 The goal of phase II trial is to evaluate the safety and efficacy of AK112 in combination therapy or monotherapy in the treatment of HCC compared to the combination of Sintilimab and Bevacizumab biosimilar
1 The goal of phase Ib trial is to evaluate the safety and tolerability of AK112 in combination therapies for the purpose of observing the incidence of dose limit toxicity DLT as well as the confirmation of maximum tolerable dose MTD in the treatment of advanced hepatocellular carcinoma HCC so as to determine the recommended phase 2 dose RP2D in the second part of the trial
2 The goal of phase II trial is to evaluate the safety and efficacy of AK112 in combination therapy or monotherapy in the treatment of HCC compared to the combination of Sintilimab and Bevacizumab biosimilar
Detailed Description:
None
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