Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06171178
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2023-12-07
Brief Title:
A Study of ASP1012 in Adults With Solid Tumors
Sponsor:
Astellas Pharma Global Development Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase 1 Open-Label Dose Escalation and Expansion Study of ASP1012 an Oncolytic Virus in Participants With Locally Advanced or Metastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
ASP1012 is a type of virus called an oncolytic virus which is used to treat some cancers
ASP1012 was changed in a laboratory to infect and kill cancer cells leaving healthy cells alone It also makes the cancer cells visible to the immune system which will fight the cancer cells
Before ASP1012 is available as a treatment the researchers need to understand how it is processed by and acts upon the body This will help find a suitable dose for future studies and check for potential medical problems from the treatment
In this study ASP1012 is being tested in humans for the first time ASP1012 has already been tested in the laboratory and in animals This is the standard way new potential treatments are developed
People in this study will be adults whose tumor has either grown outside of the area where it started locally advanced or it has spread to other parts of the body metastatic They will receive ASP1012 Also some people will receive ASP1012 with pembrolizumab an approved medicine
There are 2 main aims of this study The first is to learn if people with certain solid tumors can tolerate different doses of ASP1012 The second is to find a suitable dose of ASP1012
This study will be in 3 parts
Part 1 is called Dose Escalation People with locally advanced or metastatic tumors can take part They will have been previously treated with all available standard cancer therapies Different small groups of people will receive lower to higher doses of ASP1012
For each dose any medical problems will be recorded This will help to find suitable doses of ASP1012 to use in Parts 2 and 3 of the study The first group will receive the lowest dose of ASP1012 A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP1012 The panel will do this for each group until all groups have taken ASP1012 or until suitable doses have been selected for Parts 2 and 3
Part 2 is called Dose Expansion 3 groups will take part people with previously-treated melanoma a type of skin cancer that have not responded to their treatment refractory or their cancer has come back relapsed people with newly-diagnosed or untreated melanoma and people with previously-treated solid tumors People with previously-treated melanoma will receive ASP1012 at the dose worked out from Part 1 People with previously-treated solid tumors will receive ASP1012 with pembrolizumab The first few people will receive ASP1012 at a lower dose than the dose worked out from Part 1 to check the safety of the treatments being given together If there are no safety issues the next people in the solid tumor group will receive ASP1012 at the dose worked out from Part 1 with pembrolizumab also people with untreated melanoma will receive ASP1012 at the dose worked out from Part
1 with pembrolizumab
Part 3 is also a Dose Expansion for people with other specific cancers These are stomach cancer ovarian cancer or colorectal cancer If people with certain tumors respond well in Parts 1 and 2 of the study other people with this same type of tumor can also take part in Part 3
For all parts of the study ASP1012 will be given through a vein This is called an infusion
Each treatment cycle is 21 days long People will start with 3 treatment cycles People in the study may receive extra treatment cycles if they respond well to treatment People with melanoma who are receiving ASP1012 with pembrolizumab will not be offered the extra treatment cycles People can stop leave the study early if they have medical problems from the treatment their cancer gets worse they start other cancer treatment they ask to stop treatment or they do not come back for treatment
People will visit the clinic on certain days during their treatment Some visits will be virtual or by phone During all clinic visits the study doctors will check for any medical problems from ASP1012 They will also check vital signs Vital signs include temperature pulse breathing rate the amount of oxygen in the blood and blood pressure At some visits other checks will also include a medical examination and an electrocardiogram ECG to check the heart rhythm blood draws and urine samples for testing A tumor sample if available will be taken during the first treatment cycle People will have imaging scans and have blood draws for testing every 6 weeks during and after treatment This will stop if they leave the study early
People will visit the clinic within 7 days and 30 days after stopping treatment At both visits the study doctors will check for any medical problems from ASP1012 Other checks will include a medical examination blood draws and urine samples for testing and checking vital signs An ECG will also be done at the 7-day visit After the 30-day visit clinic staff will phone people in the study every 12 weeks to check the condition of their cancer for up to 1 year
ASP1012 was changed in a laboratory to infect and kill cancer cells leaving healthy cells alone It also makes the cancer cells visible to the immune system which will fight the cancer cells
Before ASP1012 is available as a treatment the researchers need to understand how it is processed by and acts upon the body This will help find a suitable dose for future studies and check for potential medical problems from the treatment
In this study ASP1012 is being tested in humans for the first time ASP1012 has already been tested in the laboratory and in animals This is the standard way new potential treatments are developed
People in this study will be adults whose tumor has either grown outside of the area where it started locally advanced or it has spread to other parts of the body metastatic They will receive ASP1012 Also some people will receive ASP1012 with pembrolizumab an approved medicine
There are 2 main aims of this study The first is to learn if people with certain solid tumors can tolerate different doses of ASP1012 The second is to find a suitable dose of ASP1012
This study will be in 3 parts
Part 1 is called Dose Escalation People with locally advanced or metastatic tumors can take part They will have been previously treated with all available standard cancer therapies Different small groups of people will receive lower to higher doses of ASP1012
For each dose any medical problems will be recorded This will help to find suitable doses of ASP1012 to use in Parts 2 and 3 of the study The first group will receive the lowest dose of ASP1012 A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP1012 The panel will do this for each group until all groups have taken ASP1012 or until suitable doses have been selected for Parts 2 and 3
Part 2 is called Dose Expansion 3 groups will take part people with previously-treated melanoma a type of skin cancer that have not responded to their treatment refractory or their cancer has come back relapsed people with newly-diagnosed or untreated melanoma and people with previously-treated solid tumors People with previously-treated melanoma will receive ASP1012 at the dose worked out from Part 1 People with previously-treated solid tumors will receive ASP1012 with pembrolizumab The first few people will receive ASP1012 at a lower dose than the dose worked out from Part 1 to check the safety of the treatments being given together If there are no safety issues the next people in the solid tumor group will receive ASP1012 at the dose worked out from Part 1 with pembrolizumab also people with untreated melanoma will receive ASP1012 at the dose worked out from Part
1 with pembrolizumab
Part 3 is also a Dose Expansion for people with other specific cancers These are stomach cancer ovarian cancer or colorectal cancer If people with certain tumors respond well in Parts 1 and 2 of the study other people with this same type of tumor can also take part in Part 3
For all parts of the study ASP1012 will be given through a vein This is called an infusion
Each treatment cycle is 21 days long People will start with 3 treatment cycles People in the study may receive extra treatment cycles if they respond well to treatment People with melanoma who are receiving ASP1012 with pembrolizumab will not be offered the extra treatment cycles People can stop leave the study early if they have medical problems from the treatment their cancer gets worse they start other cancer treatment they ask to stop treatment or they do not come back for treatment
People will visit the clinic on certain days during their treatment Some visits will be virtual or by phone During all clinic visits the study doctors will check for any medical problems from ASP1012 They will also check vital signs Vital signs include temperature pulse breathing rate the amount of oxygen in the blood and blood pressure At some visits other checks will also include a medical examination and an electrocardiogram ECG to check the heart rhythm blood draws and urine samples for testing A tumor sample if available will be taken during the first treatment cycle People will have imaging scans and have blood draws for testing every 6 weeks during and after treatment This will stop if they leave the study early
People will visit the clinic within 7 days and 30 days after stopping treatment At both visits the study doctors will check for any medical problems from ASP1012 Other checks will include a medical examination blood draws and urine samples for testing and checking vital signs An ECG will also be done at the 7-day visit After the 30-day visit clinic staff will phone people in the study every 12 weeks to check the condition of their cancer for up to 1 year
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None