The purpose of this study is to determine safety and anti-tumor immune activation generated by TG02 and Granulocyte macrophage colony stimulating factor (GM-CSF), first as monotherapy (Part I), thereafter in combination with the checkpoint inhibitor pembrolizumab (Part II), in patients with locally advanced primary and recurrent colorectal cancer scheduled to have surgery. Part I will include 4-6 patients and Part II will include up to 10 patients. Part I and Part II are separate and independent sequential components of the study. Patients will only be able to participate in either the Part I cohort or Part II cohort. Main objective of the study is to investigate safety and immune response after TG02-treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Royal Brisbane & Women's Hospital (RBWH)
Brisbane, Australia
Peter MacCallum Cancer Centre
Melbourne, Australia
Auckland City Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Patients Safety During Study
Safety of TG02-treatment by assessment of laboratory parameters (routine haematology and biochemistry), vital signs and recording of adverse events
Time frame: From start of study until End of study, which is approximately 4 weeks after surgery and maximum 20 weeks after start of TG02-treatment
Patients' Immune Response Assessed by Delayed Type Hypersensitive (DTH) Test
Number of patients with systemic TG02 specific immune response assessed by a Delayed Type Hypersensitivity (DTH) test
Time frame: 8 weeks
Systemic Immune Response: T-cell Response
Systemic immune response assessed as change in presence of TG02 specific T-cells in peripheral blood
Time frame: 8 weeks
Immunological Activation in Tumour Mass by Assessing Number of Patients With Increased Intra-tumoural Lymphocytes.
Immunological activation in tumour mass by assessing fold changes from baseline of intra-tumoural lymphocytes.
Time frame: 8 weeks
Change of Immune Suppression Factors e.g. PD-1 and T-reg From Pre to Post Treatment
Number of patients with changes from baseline in immune suppression factors (such as PDL1, Treg and MSDC) from tumour samples collected pre TG02/GMCSF treatment
Time frame: 8 weeks
Change in Pathological Responses and Markers of Apoptosis in Tumour Tissue
Time frame: 8 weeks
Changes in Standard Uptake Values (SUV) Will be Assessed by FDG PET-CT Images
Time frame: From screening until surgery
Changes in the Tumour Marker Carcinoembryonic Antigen (CEA) Throughout Treatment Will be Assessed by Analysis of Blood Samples to Follow the Evolution of Disease Under Treatment
Time frame: From screening until surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.