Status:
TERMINATED
PF-07265028 As Single Agent And In Combination With Sasanlimab in Advanced or Metastatic Solid Tumors
Lead Sponsor:
Pfizer
Conditions:
Advanced Solid Tumors
Gastric Cancer
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief 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-07265...
Detailed Description
The purpose of this first-in-human study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of increasing doses of PF-07265028 as monotherapy and in combination wi...
Eligibility Criteria
Inclusion
- Key
- Across all cohorts:
- 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:
- 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:
- Histologically or cytologically confirmed advanced or metastatic solid tumors which have progressed following systemic anticancer therapies, or are resistant to standard therapy or for which no standard therapy is available, or for whom standard therapy is not tolerated.
- Part 1B Combination Therapy:
- Histologically or cytologically confirmed advanced or metastatic solid tumor which have progressed following systemic anticancer therapies, including at least 1 checkpoint inhibitor.
- Part 2 Dose Expansion:
- Histologically or cytologically confirmed advanced or metastatic malignancies, including gastric/Gastroesophageal junction cancer, Head and neck squamous cell carcinoma, or urothelial cancer (non-small cell lung cancer and other solid tumors may be included) who have progressed following systemic anticancer therapies, including at least 1 checkpoint inhibitor
- Key
Exclusion
- 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
- Central nervous system metastases
- Significant cardiac or pulmonary conditions or events within previous 6 months
- Active, uncontrolled bacterial, fungal, or viral infection
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PF-07265028
- Prior administration of HPK1 inhibitor
Key Trial Info
Start Date :
February 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05233436
Start Date
February 24 2022
End Date
October 16 2023
Last Update
May 31 2024
Active Locations (12)
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1
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
2
HonorHealth Scottsdale Shea Medical Center
Scottsdale, Arizona, United States, 85260
3
D&H Cancer Research Center LLC
Margate, Florida, United States, 33063
4
Napa Research
Margate, Florida, United States, 33063