New pfizer drug shows promise against tough cancers
NCT ID NCT04553133
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug called PF-07104091 in people with advanced small cell lung cancer, ovarian cancer, or certain breast cancers that have not responded to prior treatments. The goal is to find the safest dose and see if the drug shrinks tumors, either alone or with other medicines. About 157 participants will take part in this early-phase trial.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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157 people
The number who actually took part.
- Started
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Sep 2020
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centro de Investigaciones Medicas y Desarrollo LC
Buenos Aires, Buenos Aires F.D., 1113, Argentina
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Complex Oncology Center - Plovdiv EOOD
Plovdiv, 4004, Bulgaria
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Complex Oncology Center - Shumen
Shumen, 9700, Bulgaria
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Dana-Farber Cancer Institute - Chestnut Hill
Newton, Massachusetts, 02459, United States
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Des Moines Oncology Research Association
Des Moines, Iowa, 50309, United States
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
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Laura & Isaac Perlmutter Cancer Center - NYU ACC
New York, New York, 10016, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Medical Oncology & Hematology Associates DBA Mission Cancer and Blood
Clive, Iowa, 50325, United States
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Medical Oncology & Hematology Associates DBA Mission Cancer and Blood
Des Moines, Iowa, 50309, United States
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Medical Oncology & Hematology Associates DBA Mission Cancer and Blood
Des Moines, Iowa, 50314, United States
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Memorial Sloan Kettering Cancer Center (IDS Pharmacy)
Long Island City, New York, 11101, United States
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Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
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NYU Langone Medical Center (Tisch Hospital)
New York, New York, 10016, United States
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Norton Brownsboro Hospital
Louisville, Kentucky, 40241, United States
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Norton Cancer Institute, Audubon
Louisville, Kentucky, 40217, United States
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Norton Cancer Institute, Brownsboro Campus
Louisville, Kentucky, 40241, United States
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Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, 40207, United States
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Norton Hospital
Louisville, Kentucky, 40202, United States
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Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
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UVA Breast Care Center
Charlottesville, Virginia, 22911, United States
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White Plains Hospital
White Plains, New York, 10601, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an oral drug replace injections for advanced breast cancer?