PF-07104091 as a Single Agent and in Combination Therapy

Exclusion Criteria

• •Participants with known symptomatic brain metastases requiring steroids
• •Participants with any other active malignancy within 3 years prior to enrollment
• •Major surgery within 3 weeks prior to study entry
• •Radiation therapy within 3 weeks prior to study entry.
• •Systemic anti cancer therapy within 4 weeks prior to study
• •Prior irradiation to \>25% of the bone marrow
• •Participants with active, uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, and known HIV or AIDS related illness
• •Active COVID-19/SARS-CoV2 infection
• •Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
• •Any of the following in the previous 6 months: myocardial infarction, long QT syndrome, Torsade de Pointes, arrhythmias, serious conduction system abnormalities, unstable angina, coronary/peripheral artery bypass graft, symptomatic CHF, New York Heart Association class III or IV, cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, and/or other clinical significant episode of thrombo embolic disease.
• •Anticoagulation with vitamin K antagonists or factor Xa inhibitors is not allowed.
• •Hypertension that cannot be controlled by medications
• •Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry.
• •Known or suspected hypersensitivity to active ingredient/excipients in PF 07104091.
• •Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery.
• •Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life threatening complications in the short
• •Participants with an indwelling catheter that has an external component such as those used for drainage of effusion(s) or central venous catheter that is externally
• •Previous high dose chemotherapy requiring stem cell rescue
• •Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of goserelin (if applicable).
• •Current use or anticipated need for food or drugs that are known strong CYP3A4/5 or UGT1A9 inhibitors or inducers
• •Current use or anticipated need for drugs that are known sensitive UGT1A1 substrates with narrow therapeutic
• •Serum pregnancy test positive at screening
• •Other medical or psychiatric condition