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 States21 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 range18 Years – 99 Years
SexALL
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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
✕. Participants with active autoimmune conditions or history of autoimmune diseases that may relapse
✕. History of interstitial lung disease, pneumonitis (non-infectious) or uncontrolled lung diseases
✕. History of prior immune-related adverse events (irAEs) Grade ≥3
✕
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