PF-07265028 As Single Agent And In Combination With Sasanlimab in Advanced or Metastatic Solid Tumors
NCT ID: NCT05233436
Last Updated: 2024-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
21 participants
INTERVENTIONAL
2022-02-24
2023-10-16
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1A Dose Escalation Monotherapy
Participants will receive PF-07265028 at escalating dose levels.
PF-07265028
PF-07265028 will be administered orally
Part 1B Dose Escalation Combination
Participants will receive PF-07265028 at escalating dose levels in combination with sasanlimab fixed dose
PF-07265028
PF-07265028 will be administered orally
Sasanlimab
Administered subcutaneously
Part 2A Dose Expansion Combination (SCCHN)
Participants with squamous cell carcinoma of the head and neck (SCCHN) will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B
PF-07265028
PF-07265028 will be administered orally
Sasanlimab
Administered subcutaneously
Part 2A Dose Expansion Combination (UC)
Participants with urothelial cancer (UC) will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B
PF-07265028
PF-07265028 will be administered orally
Sasanlimab
Administered subcutaneously
Part 2A Dose Expansion Combination (Gastric/GEJ)
Participants with gastric/gastroesophageal junction cancer (Gastric/GEJ) will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B
PF-07265028
PF-07265028 will be administered orally
Sasanlimab
Administered subcutaneously
Part 2A Dose Expansion Combination (NSCLC)
Participants with non small cell lung cancer (NSCLC) will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B
PF-07265028
PF-07265028 will be administered orally
Sasanlimab
Administered subcutaneously
Part 2A Dose Expansion Combination (selected tumor types)
Participants with selected tumor types will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B
PF-07265028
PF-07265028 will be administered orally
Sasanlimab
Administered subcutaneously
Part 2B Dose Expansion Monotherapy (selected tumor types)
Participants with selected tumor types will receive PF-07265028 single agent at the recommended dose from Part 1A.
PF-07265028
PF-07265028 will be administered orally
Interventions
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PF-07265028
PF-07265028 will be administered orally
Sasanlimab
Administered subcutaneously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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:
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
Exclusion Criteria
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
9. Prior administration of HPK1 inhibitor
18 Years
99 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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HonorHealth Research Institute
Scottsdale, Arizona, United States
HonorHealth Scottsdale Shea Medical Center
Scottsdale, Arizona, United States
D&H Cancer Research Center LLC
Margate, Florida, United States
Napa Research
Margate, Florida, United States
University of Iowa
Iowa City, Iowa, United States
START Midwest
Grand Rapids, Michigan, United States
Mary Crowley Cancer Research - Medical City Hospital
Dallas, Texas, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
The Cancer Institute Hospital of JFCR
Koto, Tokyo, Japan
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C4731001
Identifier Type: -
Identifier Source: org_study_id
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