CLINICAL TRIALS

Lytix Biopharma is conducting a Phase I study with three study arms:

  • TRIPLE NEGATIVE BREAST CANCER – LTX-315 in combination with pembrolizumab
  • MALIGNANT MELANOMA – LTX-315 in combination with ipilimumab
  • ALL SOLID TUMOURS – LTX-315 as monotherapy

The study is ongoing and if you want to learn more about who can participate, please contact us at trials@lytixbiopharma.com for more information.

TRIPLE NEGATIVE BREAST CANCER – patient inclusion ongoing

Patients with unresectable/metastatic triple negative breast cancer (TNBC) and at least one lesion accessible for transdermal intratumoural injection.  All patients must have received 1-4 prior treatment(s) for unresectable/metastatic TNBC and be anti-PD-1 treatment naive.

MALIGNANT MELANOMA – patient inclusion ongoing

Patients with a confirmed diagnosis of unresectable/metastatic melanoma and at least one lesion accessible for intratumoural injection. All patients must have received prior anti-PD-1 treatment for unresectable/metastatic melanoma.

ALL SOLID TUMOURS – patient inclusion ongoing

Patients with advanced cancer and at least one lesion accessible for direct transdermal injection.

The LTX-315 study is carried out at several sites in Norway and other European countries. Study investigators are recruiting patients and welcome enquiries from potential participants. Details about the trial are available at www.clinicaltrials.gov.

RATIONALE FOR LTX-315 MONO AND COMBINATION THERAPY

LTX-315 is a first in class oncolytic peptide, which binds to the surface of tumour cells and kill these cells by destroying the cell membrane. LTX-315 induces a unique immunogenic cell death mode of action leading to infiltration of cytotoxic T cells and enhanced T cell clonality in the tumour microenvironment.

There are indications that the clinical efficacy of immune checkpoint inhibitors (ICIs) (ipilimumab or pembrolizumab) is correlated with the level of T cell inflammation in the tumour microenvironment. Due to the mode of action of LTX-315, it may be ideal for combining with ICIs.

To break local immune tolerance and build an effective and sustainable systemic immune response, frequent and multiple doses of LTX-315 will be administrated at 2 consecutive days each week, for 3 weeks.

DESIGN

Phase I, open-label, multi-arm, multi-centre, multi-dose, dose escalation study of LTX-315 as monotherapy or as combination therapy with either ipilimumab or pembrolizumab in patients with transdermally accessible tumours (cutaneous, subcutaneous, oral or lymph node lesions).

OBJECTIVES

Primary:     Assessing safety and tolerability of multiple, intra-tumoural doses of LTX-315.
Secondary: Evaluate the immune effects and anti-tumour effect in injected tumour lesions of LTX-315.