Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448364
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-04-17
Brief Title:
A Study in AdvancedMetastatic Solid Tumors With the Study Medicine PF-07329640 When Given Alone or In Combination
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
FIRST-IN-HUMAN FIH OPEN-LABEL PHASE 1 DOSE ESCALATION AND EXPANSION STUDY DESIGNED TO EVALUATE THE SAFETY TOLERABILITY PK PD AND PRELIMINARY CLINICAL ACTIVITY OF PF-07329640 AS A SINGLE AGENT OR IN COMBINATION TREATMENT FOR PARTICIPANTS WITH ADVANCED SOLID TUMORS
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LTbR
Brief Summary:
The purpose of this study is to learn about the safety the impact of the study drug on the participants body effects of the study drug alone or in combination with bevacizumab or sasanlimab and to find the best dose
This study is seeking participants who have solid tumors that
have advanced cancer that doesnt disappear or stay away with treatment or
has spread to other parts of the body metastatic
This includes but limited to the following cancer types
Non-Small Cell Lung Cancer NSCLC Its a type of lung cancer where the cells grow slowly but often spread to other parts of the body
Colorectal Cancer CRC This is a disease where cells in the colon or rectum grow out of control
Urothelial Cancer UC This is a cancer that starts in the urinary systems
Melanoma Skin cancer that develops when melanocytes the cells that give the skin its tan or brown color start to grow out of control
All participants in this study will receive the study medication PF-07329640 as an IV infusion given directly into a vein at the study clinic every week for repeating 28-day cycles
Depending on which part of the study participants are enrolled in they will receive the study medication PF-07329640 alone or in combination with other anti-cancer medications bevacizumab or sasanlimab Bevacizumab is given in the clinic as IV infusion every two weeks and sasanlimab is given as a shot under the skin every 4 weeks
Participants can continue to take the study medication PF-07329640 and bevacizumab until their cancer is no longer responding Participants who are taking sasanlimab may receive it for up to 2 years
The study will look at the experiences of people receiving the study medicines This will help see if the study medicines are safe and effective
Participants will be involved in this study for up to 4 years During this time they will have a study visit every week After they have stopped taking the study medication at about at 2 years they will be followed for another two years to see how they are doing
This study is seeking participants who have solid tumors that
have advanced cancer that doesnt disappear or stay away with treatment or
has spread to other parts of the body metastatic
This includes but limited to the following cancer types
Non-Small Cell Lung Cancer NSCLC Its a type of lung cancer where the cells grow slowly but often spread to other parts of the body
Colorectal Cancer CRC This is a disease where cells in the colon or rectum grow out of control
Urothelial Cancer UC This is a cancer that starts in the urinary systems
Melanoma Skin cancer that develops when melanocytes the cells that give the skin its tan or brown color start to grow out of control
All participants in this study will receive the study medication PF-07329640 as an IV infusion given directly into a vein at the study clinic every week for repeating 28-day cycles
Depending on which part of the study participants are enrolled in they will receive the study medication PF-07329640 alone or in combination with other anti-cancer medications bevacizumab or sasanlimab Bevacizumab is given in the clinic as IV infusion every two weeks and sasanlimab is given as a shot under the skin every 4 weeks
Participants can continue to take the study medication PF-07329640 and bevacizumab until their cancer is no longer responding Participants who are taking sasanlimab may receive it for up to 2 years
The study will look at the experiences of people receiving the study medicines This will help see if the study medicines are safe and effective
Participants will be involved in this study for up to 4 years During this time they will have a study visit every week After they have stopped taking the study medication at about at 2 years they will be followed for another two years to see how they are doing
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