PF-07265028 As Single Agent And In Combination With Sasanlimab in Advanced or Metastatic Solid Tu… (NCT05233436) | Clinical Trial Compass
TerminatedPhase 1
PF-07265028 As Single Agent And In Combination With Sasanlimab in Advanced or Metastatic Solid Tumors
Stopped: Study terminated based on internal business considerations and was not based on safety reasons
United States, Japan21 participantsStarted 2022-02-24
Plain-language summary
The purpose of this study is to assess the safety and effects of PF-07265028 as monotherapy and in combination with sasanlimab.
The study aims to identify the maximum tolerated dose (MTD) of PF-07265028 as monotherapy; evaluate the clinical activity of monotherapy and combination; and select the recommended dose of PF-07265028 monotherapy and in combination for potential further studies and development.
The study contains 2 parts, Dose Escalation (Part 1) to determine the recommended dose of PF-07265028 as single agent and in combination, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.
It is expected that most participants will take part in this study for up to 1 year with six on-site visits in the first month and then at least twice every subsequent month while they are on treatment.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
. Adequate hematological, kidney and liver function
. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
. Resolved acute effects of any prior therapy
. All participants must provide archival formalin-fixed paraffin-embedded (FFPE) tumor tissue:
Exclusion criteria
. Participants with any other active malignancy within 3 years prior to enrollment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with Dose-limiting toxicities (DLTs) in Dose Escalation (Part 1)
Timeframe: Cycle 1 (28 days)
2
Number of participants with adverse events (AEs)
Timeframe: Baseline through up to 2 years
3
Number of participants with clinically significant laboratory abnormalities
Timeframe: Baseline through up to 2 years
4
Objective response rate (ORR) in Dose Expansion (Part 2)
Timeframe: Baseline through up to 2 years or until disease progression