PF-08634404
DrugConcentrate for solution for infusion
Other names: SSGJ-707
NCT Number: NCT07227415
This study is testing a new medicine called PF-08634404 and how it works in adults with advanced Renal Cell Carcinoma (RCC)- a type of kidney cancer that is either locally advanced (spread to nearby tissues) or metastatic (spread to other parts of the body). The study will look at the safety of the study medicine, when given alone or with other anticancer medicines, and how this type of cancer responds to them.
To join the study, participants must be adults; with locally advanced or metastatic RCC; who have not received treatment for their advanced kidney cancer.
Participants will receive study medicine either alone or with other anticancer medicines. The medicine will be given through intravenous (IV) infusions, which means it will be injected directly into a vein. All treatments will take place at clinical study sites, where trained medical staff will take care of participants during and after each visit.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Icon Cancer Centre Wesley, Auchenflower, Queensland, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants may be excluded if they meet any of the following:
Concentrate for solution for infusion
Other names: SSGJ-707
Solution for infusion
Other names: yervoy
Tablet
Time frame: Up to approximately 3 years
ORR is defined as the proportion of participants in the analysis population having a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v1.1 as assessed by investigator.
Time frame: Through 90 days after the last study intervention (Up to approximately 3 years)
AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
Time frame: Though end of DLT evaluation period (Up to approximately 3 years)
The number of participants who experienced DLTs during the DLT evaluation period in Cohort B (combination 1) and Cohort C (combination 2).
Time frame: Up to approximately 3 years
DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.
Time frame: Up to approximately 3 years
Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective progressive disease (PD) assessed by investigator per RECIST v1.1, or death due to any cause, whichever occurs first.
Time frame: Up to approximately 3 years
Overall survival defined as the time from the date of randomization to the date of death due to any cause.
Time frame: Time from the date of first dose of study intervention through 30-37 days after last dose of study intervention (approximately 3 years)
laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing
Time frame: Up to 37 days after the last dose of treatment
Pre-dose and post dose concentrations of PF-08634404
Time frame: Up to 37 days after the last dose of treatment
To evaluate the immunogenicity of PF-08634404
Contact information is provided by the study sponsor or research team.
Pfizer
Industry
AN INTERVENTIONAL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY AND IN COMBINATION WITH OTHER ANTICANCER AGENTS IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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