PF-07265028 As Single Agent And In Combination With Sasanlimab in Advanced or Metastatic Solid Tumors
Advanced Solid Tumors, Gastric Cancer, Gastroesophageal Junction Cancer
About this trial
This is an interventional treatment trial for Advanced Solid Tumors focused on measuring immunotherapy, advanced solid tumor, metastatic solid tumor, first in human, Gastric cancer, Gastroesophageal junction cancer, Urothelial Cancer, Non small cell lung cancer, Head and neck squamous cell carcinomas, SCCHN, NSCLC, Lung cancer, Hematopoietic progenitor kinase 1 inhibitor, HPK1 inhibitor
Eligibility Criteria
Key Inclusion Criteria:
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 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
- 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
Sites / Locations
- HonorHealth Research InstituteRecruiting
- HonorHealth Scottsdale Shea Medical CenterRecruiting
- D&H Cancer Research Center LLCRecruiting
- Napa Research
- University of IowaRecruiting
- START MidwestRecruiting
- Mary Crowley Cancer Research - Medical City HospitalRecruiting
- South Texas Accelerated Research Therapeutics (START)Recruiting
- South Texas Accelerated Research Therapeutics, LLCRecruiting
- National Cancer Center Hospital EastRecruiting
- The Cancer Institute Hospital of JFCRRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Part 1A Dose Escalation Monotherapy
Part 1B Dose Escalation Combination
Part 2A Dose Expansion Combination (SCCHN)
Part 2A Dose Expansion Combination (UC)
Part 2A Dose Expansion Combination (Gastric/GEJ)
Part 2A Dose Expansion Combination (NSCLC)
Part 2A Dose Expansion Combination (selected tumor types)
Part 2B Dose Expansion Monotherapy (selected tumor types)
Participants will receive PF-07265028 at escalating dose levels.
Participants will receive PF-07265028 at escalating dose levels in combination with sasanlimab fixed dose
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
Participants with urothelial cancer (UC) will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B
Participants with gastric/gastroesophageal junction cancer (Gastric/GEJ) will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B
Participants with non small cell lung cancer (NSCLC) will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B
Participants with selected tumor types will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B
Participants with selected tumor types will receive PF-07265028 single agent at the recommended dose from Part 1A.