Ignite Creation Date:
2024-05-06 @ 10:32 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03287427
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2017-09-12
Brief Title:
MYPHISMO MYB and PD-1 Immunotherapies Against Multiple Oncologies Trial
Sponsor:
Peter MacCallum Cancer Centre Australia
Organization:
Peter MacCallum Cancer Centre Australia
Study Overview
Official Title:
First-in-human Phase I Clinical Trial of a Combined Immune Modulatory Approach Using TetMYB Vaccine and Anti-PD1 Antibody in Patients With Advanced Solid Cancer Including Colorectal or Adenoid Cystic Carcinoma
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MYPHISMO
Brief 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 bodys 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
The immune system is the bodys 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None