Dose-escalation Study of LTX-315 in Patients With a Transdermally Accessible Tumour

2014-08-27 03:16:19 | BioPortfolio


The study will evaluate the safety profile for LTX-315 a lytic-peptide that has shown effect in animal models to kill cancer tumours when injected directly in to the tumour. The study will also monitor the immunological response in the body after injection of LTX-315.


A phase I study with an initial concentration/volume escalating part followed by an expanded cohort at the recommended dose (RD). This is an open label, multicentre study assessing the safety, tolerance, PK and efficacy of LTX-315 injected directly into transdermally accessible tumours on days 1 and 8.

Additional weekly injections may be made, for up to a total of 6 injections.

Subjects may be included in the study if they meet all of the following criteria:

1. Histologically confirmed malignant tumour

2. Transdermally accessible lesion (in or close to the skin)

3. Age ≥ 18 years

4. ECOG Performance status (PS): 0 - 2

5. Life expectancy: At least 3 months

The primary objectives of the study are to evaluate the safety profile of LTX-315 by assessment of adverse events and abnormal laboratory values recorded during the study and to determine the recommended dose of LTX-315.

The secondary objectives of the study are to preliminarily assess the anti-tumour activity of LTX-315 in patients with transdermally accessible tumours, monitor immunological response, pharmacokinetic assessment, and determine duration of response.

Study Design

Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Cancer With Transdermal Accessible Tumour


LTX-315 (Oncopore™)


Oslo University Hospital, Radiumhospitalet




Lytix Biopharma AS

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:16:19-0400

Clinical Trials [665 Associated Clinical Trials listed on BioPortfolio]

The Usefulness of Staining Lymph Nodes During Operations for Cancer Thyroid in Detecting the Nodes That Have Cancer

Detection of lymph nodes starting to be involved by cancer spreading from the thyroid gland during operation is useful. It saves the patient from having a second operation to remove these ...

Subjective Observational Study of Patients Using Transdermal Cream Medication And/Or Transdermal Patches With Or Without Oral Non-Narcotic Medications

purpose of this study is to evaluate the level of pain perceived by patients using a transdermal cream and/or transdermal patch with or without an oral medication as a pain management solu...

Efficacy of the Fentanyl Transdermal Therapeutic System (TTS) in the Management of Pain in Patients With Cancer

The purpose of this study is to evaluate the safety and effectiveness of continuous use of TTS fentanyl (a transdermal patch delivering the narcotic pain reliever fentanyl) for the treatme...

Rectal Study: Value of Repeated FDG-PET-CT Scans in Rectal Cancer

To investigate the evolution of the 18F-deoxyglucose (FDG) uptake and the tumour characteristics determined in the plasma of patients with rectal cancer during and after radiotherapy or co...

Comparison of Two Dosage Strengths of Transdermal Fentanyl Versus Transdermal Buprenorphine and Placebo in Acute Pain Models in Healthy Volunteers.

The primary objective of this pilot trial is to identify pain model(s) which allow(s) to compare and differentiate the analgesic effects between transdermal fentanyl 25µg/h, transdermal...

PubMed Articles [14564 Associated PubMed Articles listed on BioPortfolio]

Tumour Deposits are a Significant Prognostic Factor in Gastric Cancer-A Systematic Review and Meta-Analysis.

Tumour deposits (TDs) are clusters of cancer cells in the soft tissue that are discontinuous from the primary tumour. In this review we are exploring their relevance for prognosis in patients with gas...

The roles and mechanisms of G3BP1 in tumour promotion.

Ras-GTPase-activating protein SH3 domain-binding protein 1 (G3BP1) is a SH3 domain-binding protein that is overexpressed in a variety of tumour tissues and cancers, such as head and neck cancer, lung ...

PD-L1/PD-1 crosstalk in colorectal cancer: are we targeting the right cells?

The analysis of tumour-infiltrating immune cells within patients' tumour samples in colorectal cancer (CRC) has become an independent predictor of patient survival. The tumour microenvironment and the...

Prostate cancer multifocality, the index lesion, and the microenvironment.

Most of focal therapies has addressed index lesion as the targeted tumour focus to treat localized prostate cancer (PCa), a multifocal disease. The interaction between tumour foci and host cells creat...

Upper GI biopsies for Adenocarcinoma - how many biopsies should endoscopists take?

There is evidence that 4 or 5 gastric cancer biopsies are required for accurate HER2 interpretation. However, the number of biopsies that need to be taken to reach this number of viable cancer biopsie...

Medical and Biotech [MESH] Definitions

A cancer registry mandated under the National Cancer Act of 1971 to operate and maintain a population-based cancer reporting system, reporting periodically estimates of cancer incidence and mortality in the United States. The Surveillance, Epidemiology, and End Results (SEER) Program is a continuing project of the National Cancer Institute of the National Institutes of Health. Among its goals, in addition to assembling and reporting cancer statistics, are the monitoring of annual cancer incident trends and the promoting of studies designed to identify factors amenable to cancer control interventions. (From National Cancer Institute, NIH Publication No. 91-3074, October 1990)

A medicated adhesive patch placed on the skin to deliver a specific dose of medication into the bloodstream.

A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.

Removal and examination of tissue obtained through a transdermal needle inserted into the specific region, organ, or tissue being analyzed.

Chromosome regions that are loosely packaged and more accessible to RNA polymerases than HETEROCHROMATIN. These regions also stain differentially in CHROMOSOME BANDING preparations.

More From BioPortfolio on "Dose-escalation Study of LTX-315 in Patients With a Transdermally Accessible Tumour"

Quick Search


Relevant Topic

Head and neck cancers
Cancer can occur in any of the tissues or organs in the head and neck. There are over 30 different places that cancer can develop in the head and neck area. Mouth cancers (oral cancers)  - Mouth cancer can develop on the lip, the tongue, the floor...

Searches Linking to this Trial