NCT05233436

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2022

Geographic Reach
2 countries

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

February 24, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2023

Completed
Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

1.6 years

First QC Date

January 6, 2022

Last Update Submit

February 17, 2026

Conditions

Advanced Solid TumorsGastric CancerGastroesophageal Junction CancerUrothelial CancerNon Small Cell Lung CancerHead and Neck Squamous Cell Carcinomas

Keywords

immunotherapyadvanced solid tumormetastatic solid tumorfirst in humanGastric cancerGastroesophageal junction cancerUrothelial CancerNon small cell lung cancerHead and neck squamous cell carcinomasSCCHNNSCLCLung cancerHematopoietic progenitor kinase 1 inhibitorHPK1 inhibitor

Outcome Measures

Primary Outcomes (4)

  • Number of participants with Dose-limiting toxicities (DLTs) in Dose Escalation (Part 1)

    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

    Cycle 1 (28 days)

  • Number of participants with adverse events (AEs)

    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.

    Baseline through up to 2 years

  • Number of participants with clinically significant laboratory abnormalities

    Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.

    Baseline through up to 2 years

  • Objective response rate (ORR) in Dose Expansion (Part 2)

    Tumor response based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Baseline through up to 2 years or until disease progression

Secondary Outcomes (13)

  • The pharmacokinetic profile of single and multiple doses PF-07265028 alone and in combination with sasanlimab through Cmax.

    Days 1, 8, 15, 16 and 22 of Cycle 1 (each cycle is 28 days)

  • The pharmacokinetic profile of single and multiple doses PF-07265028 alone and in combination with sasanlimab through Tmax.

    Days 1, 8, 15, 16 and 22 of Cycle 1 (each cycle is 28 days)

  • The pharmacokinetic profile of single and multiple doses PF-07265028 alone and in combination with sasanlimab through AUC

    Days 1, 8, 15, 16 and 22 of Cycle 1 (each cycle is 28 days)

  • The effect of food on the pharmacokinetic profile of PF-07265028 through Cmax.

    Days 1, 8, 15, 16 and 22 of Cycle 1 (each cycle is 28 days)

  • The effect of food on the pharmacokinetic profile of PF-07265028 through Tmax

    Days 1, 8, 15, 16 and 22 of Cycle 1 (each cycle is 28 days)

  • +8 more secondary outcomes

Study Arms (8)

Part 1A Dose Escalation Monotherapy

EXPERIMENTAL

Participants will receive PF-07265028 at escalating dose levels.

Drug: PF-07265028

Part 1B Dose Escalation Combination

EXPERIMENTAL

Participants will receive PF-07265028 at escalating dose levels in combination with sasanlimab fixed dose

Drug: PF-07265028Biological: Sasanlimab

Part 2A Dose Expansion Combination (SCCHN)

EXPERIMENTAL

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-07265028Biological: Sasanlimab

Part 2A Dose Expansion Combination (UC)

EXPERIMENTAL

Participants with urothelial cancer (UC) will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B

Drug: PF-07265028Biological: Sasanlimab

Part 2A Dose Expansion Combination (Gastric/GEJ)

EXPERIMENTAL

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-07265028Biological: Sasanlimab

Part 2A Dose Expansion Combination (NSCLC)

EXPERIMENTAL

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-07265028Biological: Sasanlimab

Part 2A Dose Expansion Combination (selected tumor types)

EXPERIMENTAL

Participants with selected tumor types will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B

Drug: PF-07265028Biological: Sasanlimab

Part 2B Dose Expansion Monotherapy (selected tumor types)

EXPERIMENTAL

Participants with selected tumor types will receive PF-07265028 single agent at the recommended dose from Part 1A.

Drug: PF-07265028

Interventions

SasanlimabBIOLOGICAL

Administered subcutaneously

Also known as: PF-06801591
Part 1B Dose Escalation CombinationPart 2A Dose Expansion Combination (Gastric/GEJ)Part 2A Dose Expansion Combination (NSCLC)Part 2A Dose Expansion Combination (SCCHN)Part 2A Dose Expansion Combination (UC)Part 2A Dose Expansion Combination (selected tumor types)
PF-07265028DRUG

PF-07265028 will be administered orally

Part 1A Dose Escalation MonotherapyPart 1B Dose Escalation CombinationPart 2A Dose Expansion Combination (Gastric/GEJ)Part 2A Dose Expansion Combination (NSCLC)Part 2A Dose Expansion Combination (SCCHN)Part 2A Dose Expansion Combination (UC)Part 2A Dose Expansion Combination (selected tumor types)Part 2B Dose Expansion Monotherapy (selected tumor types)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

HonorHealth Scottsdale Shea Medical Center

Scottsdale, Arizona, 85260, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

START Midwest

Grand Rapids, Michigan, 49546, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, 78229, United States

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

The Cancer Institute Hospital of JFCR

Koto, Tokyo, 135-8550, Japan

Location

Related Links

MeSH Terms

Conditions

Stomach NeoplasmsCarcinoma, Non-Small-Cell LungSquamous Cell Carcinoma of Head and NeckNeoplasm MetastasisLung Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesCarcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeHead and Neck NeoplasmsNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2022

First Posted

February 10, 2022

Study Start

February 24, 2022

Primary Completion

October 16, 2023

Study Completion

October 16, 2023

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.

Locations

JP(2)US(6)