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 Information
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
Administrative Informations
NCT ID
NCT04628780
Organization ID
C4011001
Responsible Party
Sponsor
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
July 2021