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PF-07104091 as a Single Agent and in Combination Therapy

Trial Status: Active

To assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and / or select the Recommended Phase 2 dose (RP2D) for PF 07104091 as a single agent in participants with small cell lung, non small cell lung ovarian and breast cancers.

Inclusion Criteria

  • Participants with HR-positive HER2-negative advanced or metastatic breast cancer (received at least two prior lines in the advanced or metastatic setting including one prior line of combined CDK4/6 inhibitor and endocrine therapy and no more than two prior lines of cytotoxic chemotherapy)
  • Participants with locally recurrent/advanced or metastatic TNBC who have received up to 2 prior lines of chemotherapy in the advanced or metastatic setting
  • Participants with advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC) (histologically or cytologically proven) who have received up to 3 prior lines of therapy
  • Participants with cytological diagnosis of advanced/metastatic SCLC
  • Participants with or cytological diagnosis of advanced/metastatic NSCLC
  • Participants entering the study in the expansion cohort have at least one measurable lesion as defined by RECIST version 1.1 that has not been previously irradiated
  • Performance Status 0 or 1
  • Adequate bone marrow, hematological, kidney and liver function
  • Resolved acute effects of any prior therapy to baseline severity

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
  • COVID-19/SARS-CoV2
  • 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

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE
Massachusetts General Hospital Cancer Center
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Study C4161001 is a Phase 1, open label, multi dose, multi center, dose escalation, safety,

pharmacokinetic (PK) and pharmacodynamic study of PF-07104091 in adult patients with advanced

or metastatic small cell lung cancer (SCLC), advanced platinum resistant epithelial ovarian

cancer/fallopian tube cancer/primary peritoneal cancer, locally recurrent/advanced or

metastatic triple negative breast cancer (TNBC), HR-positive HER2-negative advanced or mBC,

advanced or metastatic non-small cell lung cancer (NSCLC). This two part study will assess

the safety and tolerability of increasing dose levels of PF-07104091 in Part 1, and establish

the recommended Phase 2 dose (RP2D) in Part 2.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Pfizer Inc

  • Primary ID C4161001
  • Secondary IDs NCI-2020-07538
  • Clinicaltrials.gov ID NCT04553133