Lamivudine for Solid Tumors
NCT Number: NCT06494579
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Relapsed/Refractory Solid Tumors
Interventions: DRUG: Lamivudine|DRUG: PD-L1 Blocker
Sponsor: Thomas Marron
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-07-15
Locations: Icahn School of Medicine at Mount Sinai, New York, New York, 10029, United States

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-(L)1 blockade for patients with relapsed/refractory metastatic solid tumors that have progressed on standard PD-(L)1 blockade.

For Phase 2, to determine the effect of adding lamivudine to PD-(L)1 blocking agents in patients with relapsed/refractory solid tumors that have progressed on prior PD-(L)1 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-(L)1 blocking agents, 6) Disease control rate (DCR).

Primary Outcome Measures: Dose limiting toxicity (DLTs) per CTCAE Version 5.0, Dose-limiting toxicity rate in the first 6 patients based on the CTCAE version 5.0. DLTs were defined as any Lamivudine-related Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0) Grade 3 or 4 adverse events., Cycle 1, each cycle is 21 days
Secondary Outcome Measures: DLT of combined treatment of lamivudine and PD-(L)1 targeted therapy., To determine the safety and tolerability of combined treatment of lamivudine and PD-(L)1 targeted therapy in patients with relapsed or refractory solid tumors. DLTs were defined as any treatment-related Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0) Grade 3 or 4 adverse events., Cycle 1, each cycle is 21 days|Best overall response rate (BORR)., Best overall response rate (BORR), defined as the percent of patients achieving a Complete Response (CR) or Partial Response (PR) on initial or subsequent imaging before initiation of subsequent line of anti-cancer therapy, End of study at 3 years|Overall survival (OS), Overall survival (OS): defined as the time from the first dosing of lamivudine and date of death, End of study at 3 years|Progression free survival (PFS):, Progression free survival (PFS): defined as the time from first dosing of lamivudine to date of objectively documented progression of disease or death, End of study at 3 years|Duration of response (DOR), Duration of response (DOR): defined as the time between the date of first response of CR or PR to the date of first documented tumor progression or death due to any cause, End of study at 3 years|Disease control rate (DCR), Disease control rate (DCR): defined as percent of patients experiencing CR, PR or Stable Disease (SD) at the time of first imaging., End of study at 3 years