JPRN-jRCT2031210676
Active, not recruiting
Phase 1
A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND EXPANSION STUDY OF PF-07265028 AS A SINGLE AGENT AND IN COMBINATION WITH SASANLIMAB EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-07265028 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS
Kawai Norisuke0 sites240 target enrollmentMarch 18, 2022
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kawai Norisuke
- Enrollment
- 240
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Key Inclusion Criteria:
- •Across all cohorts:
- •1\.Eastern Cooperative Oncology Group (ECOG) performance status \<\=1
- •2\.Adequate hematological, kidney and liver function
- •3\.Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1\.1\.
- •4\.Resolved acute effects of any prior therapy
- •5\.All participants must provide archival formalin\-fixed paraffin\-embedded (FFPE) tumor tissue:
- •Part 1: If archival sample is older than 6 months, the participant must consent to undergo a fresh biopsy during the screening.
- •Part 2 Fresh tumor biopsy during screening is required unless there is archival tissues less than 3 months old and subsequent to the last systemic anti\-cancer therapy.
- •Part 1A Monotherapy:
Exclusion Criteria
- •Key Exclusion Criteria:
- •1\.Participants with any other active malignancy within 3 years prior to enrollment
- •2\.Participants with active autoimmune conditions or history of autoimmune diseases that may relapse
- •3\.History of interstitial lung disease, pneumonitis (non\-infectious) or uncontrolled lung diseases
- •4\.History of prior immune\-related adverse events (irAEs) Grade \>\=3
- •5\.Central nervous system metastases
- •6\.Significant cardiac or pulmonary conditions or events within previous 6 months
- •7\.Active, uncontrolled bacterial, fungal, or viral infection
- •8\.Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PF\-07265028
Outcomes
Primary Outcomes
Not specified
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