Ignite Creation Date:
2024-07-17 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494579
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-27
Brief Title:
Lamivudine for Solid Tumors
Sponsor:
Thomas Marron
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
A Phase 1b2 Trial of Lamivudine in the Treatment of RelapsedRefractory Solid Tumors Progression on Anti-PD-L1 Blockade
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:
Single arm set dose clinical trial of Lamivudine for Relapsed Refractory Solid Tumors
Accrual 6-24 patients within 2 years study completion within 3 years at Mount Sinai Health System
Primary Objective
For Phase 1b to determine the safety and tolerability of Lamivudine with continued PD-L1 blockade for patients with relapsedrefractory metastatic solid tumors that have progressed on standard PD-L1 blockade
For Phase 2 to determine the effect of adding lamivudine to PD-L1 blocking agents in patients with relapsedrefractory solid tumors that have progressed on prior PD-L1 agents
Secondary Objectives Phase 1b and 2 Assess 1 Safety and Tolerability 2 Best overall response rate BORR 3 Progression-free survival PFS 4 Overall survival OS and 5 Duration of response following addition of lamivudine to standard PD-L1 blocking agents 6 Disease control rate DCR
Accrual 6-24 patients within 2 years study completion within 3 years at Mount Sinai Health System
Primary Objective
For Phase 1b to determine the safety and tolerability of Lamivudine with continued PD-L1 blockade for patients with relapsedrefractory metastatic solid tumors that have progressed on standard PD-L1 blockade
For Phase 2 to determine the effect of adding lamivudine to PD-L1 blocking agents in patients with relapsedrefractory solid tumors that have progressed on prior PD-L1 agents
Secondary Objectives Phase 1b and 2 Assess 1 Safety and Tolerability 2 Best overall response rate BORR 3 Progression-free survival PFS 4 Overall survival OS and 5 Duration of response following addition of lamivudine to standard PD-L1 blocking agents 6 Disease control rate DCR
Detailed Description:
None
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