Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580938
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
A Study to Learn About PF-07921585 Alone or With Other Anti-cancer Medicines in People With Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A PHASE 1 OPEN-LABEL DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY TOLERABILITY PHARMACOKINETICS AND ANTI-TUMOR ACTIVITY OF PF-07921585 AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 18 YEARS OF AGE AND OLDER WITH ADVANCED SOLID TUMORS
Status:
NOT_YET_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 and effects of the study medicine called PF-07921585 in people with cancer that has advanced or spread to other parts of the body
This study is seeking participants who have any of the following cancer types
non-small cell lung cancer
colorectal cancer
bladder cancer
melanoma a type of skin cancer
kidney cancer
head and neck cancer Participants will receive the study medicine PF-07921585 alone or in combination with another study medicine called sasanlimab at the study clinic
PF-07921585 will be given as an infusion into a vein or as shots under the skin once every 3 weeks Sasanlimab will be given as shots under the skin also once every 3 weeks
The experiences of participants receiving the study medicine will be studied to help see if the study medicine is safe and effective Participants may receive study medicine for up to 2 years depending on how the cancer responds to the study treatment Participants may continue receiving study medicine after 2 years if there are any benefits from the study treatment Participants will attend visits once every 3 weeks with the first 9 weeks having more frequent visits to check the safety of the study treatment
This study is seeking participants who have any of the following cancer types
non-small cell lung cancer
colorectal cancer
bladder cancer
melanoma a type of skin cancer
kidney cancer
head and neck cancer Participants will receive the study medicine PF-07921585 alone or in combination with another study medicine called sasanlimab at the study clinic
PF-07921585 will be given as an infusion into a vein or as shots under the skin once every 3 weeks Sasanlimab will be given as shots under the skin also once every 3 weeks
The experiences of participants receiving the study medicine will be studied to help see if the study medicine is safe and effective Participants may receive study medicine for up to 2 years depending on how the cancer responds to the study treatment Participants may continue receiving study medicine after 2 years if there are any benefits from the study treatment Participants will attend visits once every 3 weeks with the first 9 weeks having more frequent visits to check the safety of the study treatment
Detailed Description:
The study contains 3 parts
Part 1 dose escalation of PF-07921585 as single agent to determine the monotherapy recommended dose for further study
Part 2 dose escalation of PF-07921585 in combination with the anti-PD 1 inhibitor sasanlimab and potentially other anti-cancer agents in order to determine the recommended dose for expansion of the combination
Part 3 dose optimization expansion will evaluate PF-07921585 in combination with sasanlimab and potentially other anti-cancer agents After identification of the recommended dose for expansion in Part 2 participants with select solid tumors will be enrolled into 3-4 cohorts as follows
Cohort 1 Melanoma
Cohort 2 Microsatellite stable MSS metastatic colorectal cancer
Cohort 3 Non-small cell lung cancer NSCLC
Cohort 4 Solid tumor tumor types and clinical setting to be determined based on emerging data
Part 1 dose escalation of PF-07921585 as single agent to determine the monotherapy recommended dose for further study
Part 2 dose escalation of PF-07921585 in combination with the anti-PD 1 inhibitor sasanlimab and potentially other anti-cancer agents in order to determine the recommended dose for expansion of the combination
Part 3 dose optimization expansion will evaluate PF-07921585 in combination with sasanlimab and potentially other anti-cancer agents After identification of the recommended dose for expansion in Part 2 participants with select solid tumors will be enrolled into 3-4 cohorts as follows
Cohort 1 Melanoma
Cohort 2 Microsatellite stable MSS metastatic colorectal cancer
Cohort 3 Non-small cell lung cancer NSCLC
Cohort 4 Solid tumor tumor types and clinical setting to be determined based on emerging data
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