NCT06494579

Lamivudine for Solid Tumors

A Phase 1b/2 Trial of Lamivudine in the Treatment of Relapsed/Refractory Solid Tumors Progression on Anti-PD-(L)1 Blockade

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Thomas Marron · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Relapsed/Refractory Solid Tumors

Interventions

Type	Name	Description
DRUG	Lamivudine	Lamivudine is used in the management of human immunodeficiency virus (HIV) and Hepatitis B Virus. It is being repurposed here to assess if this can improve response to cancer immunotherapy
DRUG	PD-L1 Blocker	PD-1 or PD-L1 blocking antibodies; there are around a dozen of these FDA approved for varying indications, and whatever is administered to a patient as standard of care (FDA APPROVED) will be continued in the patients and administered in combination with lamivudine.

Timeline

• Start date: 2024-09-26
• Primary completion: 2026-07-28
• Completion: 2026-07-28
• First posted: 2024-07-10
• Last updated: 2025-12-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study