Study to Test the Safety and Tolerability of PF-07209960 in Advanced or Metastatic Solid Tumors

Study 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-07209960, an anti-PD-1 targeting IL-15 fusion protein, in participants with selected locally advanced or metastatic solid tumors for whom no standard therapy is available, or would not be an appropriate option in the opinion of the participant and their treating physician, or participants who have refused standard therapy. The study contains 2 parts, single agent Dose Escalation (Part 1) to determine the recommended dose of PF-07209960, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.

Ask AI to explain this study

Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPF-07209960

The study team can explain what participation involves.

Who it may be forLocally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 29, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?13 U.S. locations

Locations may change over time.

Who runs it?Pfizer

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Pfizer
Interventions being studied: Biological: PF-07209960

Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting

Locally advanced→Metastatic or stage IV→

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Histological/cytological diagnosis of selected locally advanced or metastatic solid tumor
Demonstrated radiographic progression on most recent tumor assessment imaging
Have ≥1 measurable lesion as defined by RECIST 1.1 that has not been previously irradiated
Eastern Cooperative Oncology Group performance status 0-2 for Part 1 and 0-1 for Part 2
Adequate hematologic, renal, liver, and coagulation functions
LVEF ≥50% by echocardiogram or MUGA
Resolved acute effects of any prior therapy
Participants in Dose Expansion (Part 2) must have ≥2 prior lines of standard of care therapy
Able to provide tumor tissue for submission to the Sponsor, including mandatory pre-treatment tumor biopsy (adequate archival tissue within the past 1 year is accepted in lieu of new biopsy) for all participants. Participants in Part 2 must also be able to undergo new (de novo) tumor biopsy at baseline (pre-treatment) and on-treatment biopsy until the Sponsor deems that an adequate number of biopsied samples have been received.

Reasons someone may not be able to joinExclusion criteria

Known active symptomatic brain or leptomeningeal metastases requiring steroids.
Other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
Major surgery or radiation therapy within 4 weeks prior to planned first dose
Last systemic anti-cancer therapy within 4 weeks prior to planned first dose (6 weeks for mitomycin C or nitrosoureas). Participants who received anti-PD-1 therapy require an interval of 90 days prior to first dose
Participation in other studies involving investigational drug(s) within 4 weeks prior to planned first dose
Active and clinically significant bacterial, fungal, or viral infection; Hepatitis B or Hepatitis C infection, AIDS-related illness (HIV+ and in good immune health as defined in the protocol may be eligible)
Active COVID-19/SARS-CoV2
Anticoagulation with vitamin K antagonists is not allowed
Active bleeding disorder in the past 6 months prior to first dose
History of clinically significant severe immune mediated adverse event that was considered related to prior immune modulatory therapy and required immunosuppressive therapy (other than hormone replacement therapy)
History of interstitial lung disease or pneumonitis
Organ transplant requiring immunosuppressive treatment or prior allogeneic bone marrow or hematopoietic stem cell transplant
Pregnant or breastfeeding female participant

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

City of Hope Investigational Drug Service (IDS)Duarte, California
City of HopeDuarte, California
Ronald Reagan UCLA Medical CenterLos Angeles, California
UCLA Hematology/OncologyLos Angeles, California
Santa Monica UCLA Medical Center & Orthopaedic HospitalSanta Monica, California
UCLA Hematology Oncology - Santa MonicaSanta Monica, California
Tennessee Oncology PLLCNashville, Tennessee
The Sarah Cannon Research Institute/Tennessee OncologyNashville, Tennessee
TriStar Centennial Medical CenterNashville, Tennessee
The University of Texas MD Anderson Cancer Center- Investigational PharmacyHouston, Texas
The University of Texas MD Anderson Cancer CenterHouston, Texas
Christus Santa Rosa HospitalSan Antonio, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 29, 2024. Always confirm current availability with the study team.

View original record ↗