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

  • End date
    Mar 22, 2025
  • participants needed
  • sponsor
Updated on 30 September 2021
measurable disease


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.

Condition Non-Small Cell Lung Cancer, Adenocarcinoma, Colorectal Cancer, Malignant neoplasm of kidney, Rectal disorder, Ovarian Cancer, Transitional cell carcinoma, Renal Cell Carcinoma, Colon Cancer Screening, Rectal Disorders, Colon cancer; rectal cancer, Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma of Head and Neck, Epithelial Ovarian Carcinoma, Recurrent Ovarian Cancer, Kidney Cancer, Malignant Adenoma, Renal Cell Cancer, Renal Cancer, Urothelial Carcinoma, clear cell renal cell carcinoma, ovarian carcinoma, ovarian epithelial carcinoma, carcinoma of the ovary, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, colorectal cancers, nsclc
Treatment PF-07209960
Clinical Study IdentifierNCT04628780
Last Modified on30 September 2021


Yes No Not Sure

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
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