Brief Summary
A Phase II, open label, single arm study to assess the efficacy of intratumoural tigilanol tiglate in various head and neck solid malignancies.
Detailed Description
Primary Objective
1. To evaluate tumoura tissue mass that forms from groups of unhealthy cells ablation following treatment(s) with intratumoural injections of tigilanol tiglate.
Secondary Objectives
- To assess the safety and tolerability of intratumoural injections with tigilanol tiglate.
- To evaluate disease control by assessing time to local disease recurrenceto occur or happen again from last treatment.
- To evaluate the tumour recurrence rate at injected tumour sites.
- To evaluate survival by assessing Progression Free Survival (PFS).
Exploratory Objectives
- To assess the impact on Quality of Lifethe overall well-being of a person diagnosed with cancer, encompassing both physical and emotional aspects of health (QoL).
- To assess the degree of wound healing after each treatment.
- To assess the tumour response in injected and non-injected tumours, based on Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
- To assess the tumour response according to intratumoural Response Evaluation Criteria in Solid Tumours (itRECIST).
- To assess changes in tumour biomarkers.
- To assess the tumour microenvironment.
Intervention / Treatment
- Drug: Tigilanol Tiglate
Inclusion Criteria:
- Are willing and able to provide written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. for the study prior to any protocol-specific procedures and to comply with all local and study requirements.
- Are ≥ 18 years of age on the day of providing informed consent.
- Have a histologically confirmed diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of a solid head and neck malignancy and have either recurrent disease and/or metastatic disease, or have failed on at least one line of systemic therapy. Tumour types can include: HNSCC, sino-nasal cancers, salivary gland cancers, and peri-stomal laryngeal carcinomas with pre-existing tracheostomya surgical procedure to create an opening in the neck and into the trachea to allow air to enter the lungs.
- Have disease that is amenable to intratumoural injection either by palpation or under ultrasounda type of medical imaging that uses soundwaves to create detailed images of the body guided injection. Lymph nodessmall bean-shaped structures that filters harmful substances from lymph fluid with metastatic disease from the patient’s head and neck cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs can be selected for treatment. Note: Measurable disease as per RECIST v1.1. is not mandatory.
- Have an Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of ≤ 2.
- Have life expectancy of more than 12 weeks.
- Female participants who are Women of Child-Bearing Potential (WOCBP) must have a negative serum pregnancy test at Screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening (within 14 days of the first study drug administration), must be willing to use a highly effective contraception from date of consent, throughout the study period and up to 30 days after the last study drug administration, and must not be breastfeeding.
- Male participants with a potentially fertile female partner are eligible if they have had a vasectomy or are willing to use adequate contraception from prior to commencement of study drug administration, throughout the study period and up to 30 days after the last study drug administration, and must not donate sperm throughout the study period and up to 30 days after the last study drug administration.