PF-07104091 as a Single Agent and in Combination Therapy

Running, not enrolling · Phase 2

Conditions studied: Small Cell Lung Cancer, Ovarian Cancer, Breast Cancer

In brief

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 advanced or metastatic small cell lung, breast and ovarian cancers.

Key facts

Study ID

NCT04553133

Run by

Pfizer

People needed

157

Starts

2020-09-16

Expected to finish

2026-12-31

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 at least 1 systemic anti-cancer therapy containing a platinum analog
• Participants with cytological diagnosis of advanced/metastatic SCLC
• Participants with or cytological diagnosis of advanced/metastatic NSCLC
• Participants with HR-positive HER2-negative advanced or metastatic breast cancer (second line plus setting) (histologically or cytologically proven).
• 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

You may not qualify if…

• 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

Where it is running

• Medical Oncology & Hematology Associates DBA Mission Cancer and Blood — Clive, Iowa, United States
• Des Moines Oncology Research Association — Des Moines, Iowa, United States
• Medical Oncology & Hematology Associates DBA Mission Cancer and Blood — Des Moines, Iowa, United States
• Medical Oncology & Hematology Associates DBA Mission Cancer and Blood — Des Moines, Iowa, United States
• Norton Hospital — Louisville, Kentucky, United States
• Norton Cancer Institute, St. Matthews Campus — Louisville, Kentucky, United States
• Norton Cancer Institute, Audubon — Louisville, Kentucky, United States
• Norton Brownsboro Hospital — Louisville, Kentucky, United States
• Norton Cancer Institute, Brownsboro Campus — Louisville, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute - Chestnut Hill — Newton, Massachusetts, United States
• Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
• Memorial Sloan Kettering Cancer Center (IDS Pharmacy) — Long Island City, New York, United States
• Laura & Isaac Perlmutter Cancer Center - NYU ACC — New York, New York, United States
• NYU Langone Medical Center (Tisch Hospital) — New York, New York, United States
• White Plains Hospital — White Plains, New York, United States
• UVA Breast Care Center — Charlottesville, Virginia, United States
• Centro de Investigaciones Medicas y Desarrollo LC — Buenos Aires, Buenos Aires F.D., Argentina
• Complex Oncology Center - Plovdiv EOOD — Plovdiv, Bulgaria
• Complex Oncology Center - Shumen — Shumen, Bulgaria
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China

Full record on ClinicalTrials.gov

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