Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | Study to Test the Safety and Tolerability of PF-07209960 in Advanced or Metastatic Solid Tumors
