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

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

INTRODUCTION

  • Org Study ID: C4731001
  • Secondary ID: N/A
  • NTC ID: NCT05233436
  • Sponsor: Pfizer
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BRIEF SUMMARY

This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and dose expansion study intended to evaluate the safety, pharmacokinetic, pharmacodynamic and potential clinical benefit of PF-07265028 as a single agent and in combination with sasanlimab, Anti-programmed cell death-1 (PD-1) monoclonal antibody, in participants with advanced or metastatic solid tumors for whom no standard therapy is available.

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-07257876 as single agent and in combination, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.

  • Overall Status
    Recruiting
  • Start Date
    February 24, 2022
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of participants with Dose-limiting toxicities (DLTs) in Dose Escalation (Part 1)

Primary Outcome 1 - Timeframe: Cycle 1 (28 days)

Primary Outcome 2 - Measure: Number of participants with adverse events (AEs)

Primary Outcome 2 - Timeframe: Baseline through up to 2 years

Primary Outcome 3 - Measure: Number of participants with clinically significant laboratory abnormalities

Primary Outcome 3 - Timeframe: Baseline through up to 2 years

Primary Outcome 4 - Measure: Objective response rate (ORR) in Dose Expansion (Part 2)

Primary Outcome 4 - Timeframe: Baseline through up to 2 years or until disease progression

CONDITION

  • Advanced Solid Tumors
  • Gastric Cancer
  • Gastroesophageal Junction Cancer
  • Urothelial Cancer
  • Non Small Cell Lung Cancer
  • Head and Neck Squamous Cell Carcinomas

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Pfizer CT.gov Call Center

Role: Study Director

Affiliation: Pfizer

Overall Contact

Name: Pfizer CT.gov Call Center

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

LOCATION

Facility Status Contact
Facility: HonorHealth Research Institute
Scottsdale, Arizona 85258
United States
Status: Recruiting Contact: N/A
Facility: HonorHealth Scottsdale Shea Medical Center
Scottsdale, Arizona 85260
United States
Status: Recruiting Contact: N/A
Facility: START Midwest
Grand Rapids, Michigan 49546
United States
Status: Recruiting Contact: N/A
Facility: South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas 78229
United States
Status: Recruiting Contact: N/A
Facility: South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas 78229
United States
Status: Recruiting Contact: N/A
Facility: National Cancer Center Hospital East
Kashiwa, Chiba 277-8577
Japan
Status: Recruiting Contact: N/A
Facility: The Cancer Institute Hospital of JFCR
Koto, Tokyo 135-8550
Japan
Status: Recruiting Contact: N/A