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PF-07265028 As Single Agent And In Combination With Sasanlimab in Advanced or Metastatic Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05233436
Recruitment Status : Recruiting
First Posted : February 10, 2022
Last Update Posted : April 6, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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-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.


Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Gastric Cancer Gastroesophageal Junction Cancer Urothelial Cancer Non Small Cell Lung Cancer Head and Neck Squamous Cell Carcinomas Drug: PF-07265028 Biological: Sasanlimab Phase 1

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 with sasanlimab; identify the maximum tolerated dose (MTD) of PF-07265028 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 24, 2022
Estimated Primary Completion Date : January 4, 2026
Estimated Study Completion Date : July 5, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1A Dose Escalation Monotherapy
Participants will receive PF-07265028 at escalating dose levels.
 Drug: PF-07265028
PF-07265028 will be administered orally
Experimental: Part 1B Dose Escalation Combination
Participants will receive PF-07265028 at escalating dose levels in combination with sasanlimab fixed dose
 Drug: PF-07265028
PF-07265028 will be administered orally

Biological: Sasanlimab
Administered subcutaneously
Other Name: PF-06801591
Experimental: 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
 Drug: PF-07265028
PF-07265028 will be administered orally

Biological: Sasanlimab
Administered subcutaneously
Other Name: PF-06801591
Experimental: 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
 Drug: PF-07265028
PF-07265028 will be administered orally

Biological: Sasanlimab
Administered subcutaneously
Other Name: PF-06801591
Experimental: 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
 Drug: PF-07265028
PF-07265028 will be administered orally

Biological: Sasanlimab
Administered subcutaneously
Other Name: PF-06801591
Experimental: 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
 Drug: PF-07265028
PF-07265028 will be administered orally

Biological: Sasanlimab
Administered subcutaneously
Other Name: PF-06801591
Experimental: 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
 Drug: PF-07265028
PF-07265028 will be administered orally

Biological: Sasanlimab
Administered subcutaneously
Other Name: PF-06801591
Experimental: 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.
 Drug: PF-07265028
PF-07265028 will be administered orally


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with Dose-limiting toxicities (DLTs) in Dose Escalation (Part 1) [ Time Frame: Cycle 1 (28 days) ]
    DLTs will be evaluated during Cycle 1 (a cycle is 28 days) in Part 1. The number of DLTs will be used to determine the optimal dose

  2. Number of participants with adverse events (AEs) [ Time Frame: Baseline through up to 2 years ]
    AEs characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0), timing, seriousness, and relationship to study therapy.

  3. Number of participants with clinically significant laboratory abnormalities [ Time Frame: Baseline through up to 2 years ]
    Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.

  4. Objective response rate (ORR) in Dose Expansion (Part 2) [ Time Frame: Baseline through up to 2 years or until disease progression ]
    Tumor response based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1


Secondary Outcome Measures :
  1. The pharmacokinetic profile of single and multiple doses PF-07265028 alone and in combination with sasanlimab through Cmax. [ Time Frame: Days 1, 8, 15, 16 and 22 of Cycle 1 (each cycle is 28 days) ]
    Maximum observed plasma concentration of PF-07265028 (Cmax) and Maximum observed steady state plasma concentration (Cmax, ss)

  2. The pharmacokinetic profile of single and multiple doses PF-07265028 alone and in combination with sasanlimab through Tmax. [ Time Frame: Days 1, 8, 15, 16 and 22 of Cycle 1 (each cycle is 28 days) ]
    Time to maximal observed plasma concentration of PF-07265028 (Tmax) and Time to reach Maximum Observed Steady State Plasma Concentration (Tmax,ss).

  3. The pharmacokinetic profile of single and multiple doses PF-07265028 alone and in combination with sasanlimab through AUC [ Time Frame: Days 1, 8, 15, 16 and 22 of Cycle 1 (each cycle is 28 days) ]
    Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-07265028 and area under the curve within one dose interval at steady state (AUCtau,ss)

  4. The effect of food on the pharmacokinetic profile of PF-07265028 through Cmax. [ Time Frame: Days 1, 8, 15, 16 and 22 of Cycle 1 (each cycle is 28 days) ]
    Maximum observed plasma concentration of PF-07265028 (Cmax) under fasted and fed conditions in the subset of participants

  5. The effect of food on the pharmacokinetic profile of PF-07265028 through Tmax [ Time Frame: Days 1, 8, 15, 16 and 22 of Cycle 1 (each cycle is 28 days) ]
    Time to maximal observed plasma concentration of PF-07265028 (Tmax) under fasted and fed conditions in the subset of participants

  6. The effect of food on the pharmacokinetic profile of PF-07265028 through AUC [ Time Frame: Days 1, 8, 15, 16 and 22 of Cycle 1 (each cycle is 28 days) ]
    Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-07265028 under fasted and fed conditions in the subset of participants

  7. The pharmacokinetic profile of sasanlimab when given in combination with PF-07265028 through Cmin [ Time Frame: Day 1 of cycle 1 (each cycle is 28 days), Day 1 of cycle 2, Day 1 of cycle 3, Day 1 of cycle 5 and thereafter every 6 cycles (each cycle is 28 days) ]
    Minimum plasma concentration (Cmin) will be calculated through the measured pre-dose plasma concentration

  8. The immunogenicity of sasanlimab when given in combination with PF-07265028 through ADA and NAb [ Time Frame: Day 1 of cycle 1 (each cycle is 28 days), Day 1 of cycle 2, Day 1 of cycle 3, Day 1 of cycle 5 and thereafter every 6 cycles (each cycle is 28 days) ]
    Incidence and titers of anti-drug antibodies (ADA) and neutralizing antibodies (NAb) against sasanlimab

  9. The effect of PF-07265028 alone and in combination with sasanlimab on tumor immune biomarkers modulation [ Time Frame: Baseline through up to 2 years ]
    Levels of intratumor T cells and PD-L1 expression in pre- and post-treatment tumor biopsies

  10. ORR in Dose Escalation (Part 1) [ Time Frame: From baseline through disease progression or study completion (approximately 2 years) ]
    Tumor response assessment based on RECIST 1.1

  11. Time to event endpoints (DOR) in Dose Expansion (Part 2) [ Time Frame: From baseline through disease progression or study completion (approximately 2 years) ]
    Duration of response (DOR) as assessed using RECIST 1.1.

  12. Time to event endpoints (PFS) in Dose Expansion (Part 2) [ Time Frame: From baseline through disease progression or study completion (approximately 2 years) ]
    Progression free survival (PFS) as assessed using RECIST 1.1.

  13. Time to event endpoints (OS) in Dose Expansion (Part 2) [ Time Frame: From baseline through disease progression or study completion (approximately 2 years) ]
    Overall survival (OS) assessed proportion of patients alive


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

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:

  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
  9. Prior administration of HPK1 inhibitor
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05233436


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, Arizona
HonorHealth Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
HonorHealth Scottsdale Shea Medical Center Recruiting
Scottsdale, Arizona, United States, 85260
United States, Florida
Napa Research - Margate Not yet recruiting
Margate, Florida, United States, 33063
Napa Research Not yet recruiting
Margate, Florida, United States, 33063
United States, Iowa
University of Iowa Not yet recruiting
Iowa City, Iowa, United States, 52242
United States, Michigan
START Midwest Recruiting
Grand Rapids, Michigan, United States, 49546
United States, Texas
Mary Crowley Cancer Research - Medical City Hospital Recruiting
Dallas, Texas, United States, 75230
South Texas Accelerated Research Therapeutics (START) Recruiting
San Antonio, Texas, United States, 78229
South Texas Accelerated Research Therapeutics, LLC Recruiting
San Antonio, Texas, United States, 78229
Japan
National Cancer Center Hospital East Recruiting
Kashiwa, Chiba, Japan, 277-8577
The Cancer Institute Hospital of JFCR Recruiting
Koto, Tokyo, Japan, 135-8550
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05233436    
Other Study ID Numbers: C4731001
First Posted: February 10, 2022    Key Record Dates
Last Update Posted: April 6, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
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
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Stomach Neoplasms
Squamous Cell Carcinoma of Head and Neck
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms