Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364696
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-10
Brief Title:
A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
An Open-label Phase 1 Study of ASP4396 in Participants With Locally Advanced Unresectable or Metastatic Solid Tumor Malignancies With KRAS G12D Mutation
Status:
RECRUITING
Status Verified Date:
2024-09
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:
Genes contain genetic code which tell the body which proteins to make Some types of cancer are caused by changes or mutations in a gene called KRAS Researchers are looking for ways to stop the actions of abnormal proteins made from the mutated KRAS gene The so-called G12D mutation in the KRAS gene is common in people with some solid tumors
ASP4396 is being developed as a potential new treatment for solid tumors in people who have the G12D mutation in their KRAS gene ASP4396 is not currently available as a treatment for the public In this study researchers will learn how ASP4396 is processed by and acts upon the body This information will help find a suitable dose and to check for potential medical problems from ASP4396
In this study ASP4396 is being given to humans for the first time
People in this study will be adults with locally advanced unresectable or metastatic solid tumors with the G12D mutation in their KRAS gene Locally advanced means the cancer has spread to nearby tissue Unresectable means the cancer cannot be removed by surgery Metastatic means the cancer has spread to other parts of the body They may have been previously treated with standard therapies or refused to receive those treatments
The main aims of the study are to check the safety of ASP4396 how well people cope with medical problems during the study how well it is tolerated and to find a suitable dose of ASP4396
This is an open-label study This means that people in this study and clinic staff will know that they will receive ASP4396
This study will be in 2 parts
Part 1 is called Dose Escalation Different small groups of people will receive lower to higher doses of ASP4396 For each dose all medical problems will be recorded The first group will receive the lowest dose of ASP4396 A medical expert panel will check the results and decide if the next group can receive a higher dose of ASP4396 The panel will do this until all groups have taken ASP4396 or until suitable doses have been selected for Part 2
Part 2 is called Dose Expansion Other different small groups of people will receive ASP4396 with the most suitable doses worked out from Part 1 This will help find a more accurate dose of ASP4396 to use in future studies
In both parts of the study ASP4396 will be given through a vein This is called an infusion Each treatment cycle is 21 days long People will continue treatment until they have medical problems from the treatment they cant cope with cant tolerate their cancer gets worse they start other cancer treatment or they ask to stop treatment
People will visit the clinic on certain days during their treatment with extra visits during the first 2 cycles of treatment The study doctors will check for any medical problems from ASP4396 Also people in the study will have a health check including blood tests On some visits they will also have scans to check for any changes in their cancer Tumor samples will be taken at certain visits during treatment with the option of a tumor sample being taken after treatment has finished
People will visit the clinic about 7 days after they stop treatment They will be asked about any medical problems and will have a health check including blood tests
After this people will visit the clinic for a health check several times The number of visits and checks done at each visit will depend on the health of each person and whether they completed their treatment or not
After treatment has finished people in the study will be followed up for up to 45 weeks
ASP4396 is being developed as a potential new treatment for solid tumors in people who have the G12D mutation in their KRAS gene ASP4396 is not currently available as a treatment for the public In this study researchers will learn how ASP4396 is processed by and acts upon the body This information will help find a suitable dose and to check for potential medical problems from ASP4396
In this study ASP4396 is being given to humans for the first time
People in this study will be adults with locally advanced unresectable or metastatic solid tumors with the G12D mutation in their KRAS gene Locally advanced means the cancer has spread to nearby tissue Unresectable means the cancer cannot be removed by surgery Metastatic means the cancer has spread to other parts of the body They may have been previously treated with standard therapies or refused to receive those treatments
The main aims of the study are to check the safety of ASP4396 how well people cope with medical problems during the study how well it is tolerated and to find a suitable dose of ASP4396
This is an open-label study This means that people in this study and clinic staff will know that they will receive ASP4396
This study will be in 2 parts
Part 1 is called Dose Escalation Different small groups of people will receive lower to higher doses of ASP4396 For each dose all medical problems will be recorded The first group will receive the lowest dose of ASP4396 A medical expert panel will check the results and decide if the next group can receive a higher dose of ASP4396 The panel will do this until all groups have taken ASP4396 or until suitable doses have been selected for Part 2
Part 2 is called Dose Expansion Other different small groups of people will receive ASP4396 with the most suitable doses worked out from Part 1 This will help find a more accurate dose of ASP4396 to use in future studies
In both parts of the study ASP4396 will be given through a vein This is called an infusion Each treatment cycle is 21 days long People will continue treatment until they have medical problems from the treatment they cant cope with cant tolerate their cancer gets worse they start other cancer treatment or they ask to stop treatment
People will visit the clinic on certain days during their treatment with extra visits during the first 2 cycles of treatment The study doctors will check for any medical problems from ASP4396 Also people in the study will have a health check including blood tests On some visits they will also have scans to check for any changes in their cancer Tumor samples will be taken at certain visits during treatment with the option of a tumor sample being taken after treatment has finished
People will visit the clinic about 7 days after they stop treatment They will be asked about any medical problems and will have a health check including blood tests
After this people will visit the clinic for a health check several times The number of visits and checks done at each visit will depend on the health of each person and whether they completed their treatment or not
After treatment has finished people in the study will be followed up for up to 45 weeks
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