Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06294548
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-02-28
Brief Title:
A Study of Valemetostat Tosylate DS-3201b with Atezolizumab and Bevacizumab in HCC
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
A Phase IbII Dose Escalation and Dose Expansion Study of Valemetostat Tosylate DS-3201b with Atezolizumab and Bevacizumab in Advanced Hepatocellular Carcinoma HCC
Status:
NOT_YET_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:
This is a phase IbII dose escalation and dose expansion study of valemetostat DS-3201 with atezolizumab and bevacizumab in patients advanced Hepatocellular carcinoma HCC who did not receive prior systemic therapy for advanced HCC
Detailed Description:
Patients will be started on valemetostat DS-3201 with atezolizumab and bevacizumab restaging scans will be performed every 9 weeks The treatment will be continued until progressive disease PD unacceptable toxicity or consent withdrawal Paired research biopsies will be performed
This study will enroll up to approximately 45-patients at UAB It is estimated 2 patients will be enrolled per month over up to 36 months period
Patients will receive valemetostat DS-3201 orally daily at their assigned dose level plus atezolizumab 1200 mg intravenously IV on day 1 and bevacizumab 15 mgkg IV on day 1 of each cycle Each cycle is 21 days Atezolizumab and bevacizumab will be administered based on institutional guidelines and practice at the FDA approved dosages and intervals for advanced HCC Valemetostat should be taken immediately prior to the start of atezolizumab and bevacizumab infusion on day 1 of each cycle
This study will enroll up to approximately 45-patients at UAB It is estimated 2 patients will be enrolled per month over up to 36 months period
Patients will receive valemetostat DS-3201 orally daily at their assigned dose level plus atezolizumab 1200 mg intravenously IV on day 1 and bevacizumab 15 mgkg IV on day 1 of each cycle Each cycle is 21 days Atezolizumab and bevacizumab will be administered based on institutional guidelines and practice at the FDA approved dosages and intervals for advanced HCC Valemetostat should be taken immediately prior to the start of atezolizumab and bevacizumab infusion on day 1 of each cycle
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?:
False
Is an FDA AA801 Violation?:
None