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

Brief Title

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

Official Title

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

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.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

 ORR in Dose Escalation (Part 1)

Condition

Non-small-cell Lung Cancer

Intervention

PF-07209960

Study Arms / Comparison Groups

 Dose Escalation (Part 1)

Description:  Participants will receive PF-07209960 at escalating dose levels

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

172

Start Date

December 16, 2020

Completion Date

March 22, 2025

Primary Completion Date

October 18, 2023

Eligibility Criteria

        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

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Pfizer CT.gov Call Center, 1-800-718-1021, [email protected]

Location Countries

United States

Location Countries

United States

NCT ID

NCT04628780

Organization ID

C4011001

Responsible Party

Sponsor

Study Sponsor

Pfizer

Study Sponsor

Pfizer CT.gov Call Center, Study Director, Pfizer

Verification Date

September 2021