MYPHISMO: MYB and PD-1 Immunotherapies Against Multiple Oncologies Trial
Status:
Not yet recruiting
Trial end date:
2022-12-30
Target enrollment:
Participant gender:
Summary
The purpose of this research study is to look at the effects, good or bad, of TetMYB Vaccine
in combination with BGB-A317 in patients with advanced or metastatic solid cancers (including
colorectal or adenoid cystic cancer).
The immune system is the body's defence against cancer, bacteria and viruses. TetMYB Vaccine
is a vaccine that helps your immune system to recognise the cancer cells. BGB-A317 is an
antibody (a type of protein made in the body in response to a foreign substance) that helps
to stop or reverse the growth of tumour cells.
Up to 32 participants may take part in this study, which is divided into 2 stages: dose
escalation (different doses will be tested in small groups of patients) and dose expansion
(one or more doses may be tested in a larger group of patients). Which stage you participate
in will depend on which is open at the time. Your study doctor will discuss this with you.
During dose escalation, study patients will receive increasing doses of the TetMYB Vaccine,
starting at a low dose. During dose expansion, study patients will receive the dose
determined as safe in dose escalation.
The study design is as follows:
In the dose finding stage, the first patient of each dose level will receive 6 consecutive
weekly doses of intradermal TetMYB monotherapy for safety evaluation. If there are no
reported DLTs, the next 2 patients of the same dose level will also receive 6 consecutive
weekly intradermal doses of TetMYB, however with 3 weekly doses of BGB-A317 commencing with
the fourth TetMYB dose. The dosage of TetMYB are as follows:
- Dose level 1: 100 ug in 100 uL of sterile dH2O containing 5% DMSO
- Dose level 2: 500 ug in 100 uL of sterile dH2O containing 5% DMSO
- Dose level 3: 1000 ug in 100 uL of sterile dH2O containing 5% DMSO.
In the dose expansion stage, the dosage will be the maximum tolerated dose (MTD) identified
in the dose-finding stage and in combination with BGB-A317.
TetMYB Vaccine is being developed and manufactured by the Peter MacCallum Cancer Centre
according to Good Manufacturing Practice (GMP) and in accordance with guidelines provided by
the Food and Drug Administration (FDA) in the USA and Therapeutic Goods Administration (TGA)
in Australia. TetMYB Vaccine is an experimental treatment and is currently not approved for
use in any country. This means that it is not an approved treatment for cancer in Australia.
This will be the first time that the TetMYB vaccine is given to humans.
BGB-A317 is being developed by BeiGene, a biopharmaceutical company. BGB-A317 is an
experimental treatment. This means that it is not an approved treatment for solid cancers in
Australia.