A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC, AND ANTI-TUMOR ACTIVITY OF PF-07209960 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS

INTRODUCTION

  • Org Study ID: C4011001
  • Secondary ID: N/A
  • NTC ID: NCT04628780
  • 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-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.

  • Overall Status
    Recruiting
  • Start Date
    December 16, 2020
  • 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: Baseline through 28 days after first dose (Cycle 1)

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 the Expansion cohorts (Part 2)

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

CONDITION

  • Non-small-cell Lung Cancer
  • Squamous Cell Carcinoma of the Head and Neck
  • Renal Cell Carcinoma
  • Urothelial Carcinoma
  • Colorectal Carcinoma
  • Ovarian Carcinoma

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

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: City of Hope Investigational Drug Service (IDS)
Duarte, California 91010
United States
Status: Recruiting Contact: N/A
Facility: City of Hope
Duarte, California 91010
United States
Status: Recruiting Contact: N/A
Facility: Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
United States
Status: Recruiting Contact: N/A
Facility: UCLA Hematology/Oncology
Los Angeles, California 90095
United States
Status: Recruiting Contact: N/A
Facility: Santa Monica UCLA Medical Center & Orthopaedic Hospital
Santa Monica, California 90404
United States
Status: Recruiting Contact: N/A
Facility: UCLA Hematology Oncology - Santa Monica
Santa Monica, California 90404
United States
Status: Recruiting Contact: N/A
Facility: The Sarah Cannon Research Institute/Tennessee Oncology
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: N/A
Facility: TriStar Centennial Medical Center
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: N/A
Facility: The University of Texas MD Anderson Cancer Center- Investigational Pharmacy
Houston, Texas 77030
United States
Status: Recruiting Contact: N/A
Facility: The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: N/A
Facility: Christus Santa Rosa Hospital
San Antonio, Texas 78229
United States
Status: Recruiting Contact: N/A
Facility: NEXT Oncology
San Antonio, Texas 78229
United States
Status: Recruiting Contact: N/A