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

Phase 1TerminatedNCT04628780

Pfizer37 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-small-cell Lung Cancer Squamous Cell Carcinoma of the Head and Neck Renal Cell Carcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion 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. Exclusion 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

Locations (13)

City of Hope Investigational Drug Service (IDS)

Duarte, California, United States

City of Hope

Duarte, California, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

UCLA Hematology/Oncology

Los Angeles, California, United States

Santa Monica UCLA Medical Center & Orthopaedic Hospital

Santa Monica, California, United States

UCLA Hematology Oncology - Santa Monica

Santa Monica, California, United States

Tennessee Oncology PLLC

Nashville, Tennessee, United States

The Sarah Cannon Research Institute/Tennessee Oncology

Nashville, Tennessee, United States

TriStar Centennial Medical Center

Nashville, Tennessee, United States

The University of Texas MD Anderson Cancer Center- Investigational Pharmacy

Houston, Texas, United States

...and 3 more locations

Outcomes

Primary Outcomes

Number of Participants With Dose Limiting Toxicities (DLTs)

For the purpose of dose escalation, any of the following adverse events were classified as DLTs: Occur in the first cycle of treatment, or within 28 days after the start of the study treatment; and were at least possibly related to PF-07209960; A participant was classified as DLT evaluable if he/she experienced a DLT or if he/she otherwise in the absence of a DLT received 2 doses of the study intervention during Cycle 1 and had received all scheduled safety assessments during the DLT window. If a participant failed to meet these criteria, he/she might be replaced. Monitoring for DLTs occurred during Part 1.

Time frame: Cycle 1 (28 days)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Adverse event (AE) was any untoward medical occurrence in a participant who received any study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 90 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. Treatment-related AEs were those related to any study drug (ie, at least one of the study drugs).