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Lamivudine for Solid Tumors

NCT06494579 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-08-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Thomas Marron

    lead OTHER

Principal Investigators

  • Thomas Marron, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-26
Primary Completion
2026-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06494579 on ClinicalTrials.gov