Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546553
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
A Study to Learn About How Different Amounts of the Study Medicine PF-07826390 Act in the Body of People With Cancer When Taken Alone or With Other Anti-cancer Medicines
Sponsor:
None
Organization:
None
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-07826390 AS A SINGLE AGENT OR IN COMBINATION TREATMENT FOR PARTICIPANTS WITH ADVANCED SOLID TUMORS
Status:
RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
The purpose of this study is to learn about the
safety the effect of the study medicine on the participants body
effects of the study medicine alone or in combination with sasanlimab -
the best amount of the study medicine
This study is seeking participants who have solid tumors An abnormal mass of tissue that
have advanced cancer that does not disappear or stay away with treatment or
are metastatic has spread to other parts of the body
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
Renal Cell Carcinoma RCC This is a cancer that starts in the kidney
All participants in this study will receive the study medication PF-07826390 as an IV infusion given directly into a vein at the study once every four weeks in 28 day cycles
The study participants depending on the group enrolled in will receive the study medication PF-07826390 alone or in combination with other anti-cancer medications sasanlimab Sasanlimab is given as a shot under the skin every 4 weeks
Participants can continue to take the study medication PF-07826390 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 participants will have a study visit every week The participants after stopping the study medicine at about 2 years will be followed for another two years to see how the participants are doing
safety the effect of the study medicine on the participants body
effects of the study medicine alone or in combination with sasanlimab -
the best amount of the study medicine
This study is seeking participants who have solid tumors An abnormal mass of tissue that
have advanced cancer that does not disappear or stay away with treatment or
are metastatic has spread to other parts of the body
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
Renal Cell Carcinoma RCC This is a cancer that starts in the kidney
All participants in this study will receive the study medication PF-07826390 as an IV infusion given directly into a vein at the study once every four weeks in 28 day cycles
The study participants depending on the group enrolled in will receive the study medication PF-07826390 alone or in combination with other anti-cancer medications sasanlimab Sasanlimab is given as a shot under the skin every 4 weeks
Participants can continue to take the study medication PF-07826390 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 participants will have a study visit every week The participants after stopping the study medicine at about 2 years will be followed for another two years to see how the participants are doing
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None