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Active Not RecruitingPhase 2NCT04553133
Official study title

PF-07104091 as a Single Agent and in Combination Therapy

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPF-07104091 monotherapy dose escalation and PF-07104091 + palbociclib + fulvestrant

Plus 5 other study approaches.

Who it may be forSmall cell lung cancer (SCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 6, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 2

Interventional

Where is it offered?22 U.S. locations

Locations may change over time.

Who runs it?Pfizer

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Pfizer
Interventions being studied
Drug: PF-07104091 monotherapy dose escalation; Drug: PF-07104091 + palbociclib + fulvestrant; Drug: PF-07104091 + palbociclib + letrozole; Drug: PF-07104091 monotherapy dose expansion (ovarian); Drug: PF-07104091 monotherapy dose expansion (SCLC); Drug: PF-07104091 + Fulvestrant (post CDK4/6); Drug: PF-0704091 + Fulvestrant (post CDK4/6)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Small cell lung cancer (SCLC)→
Disease setting
Metastatic or stage IV→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Medical Oncology & Hematology Associates DBA Mission Cancer and BloodClive, Iowa
  • Des Moines Oncology Research AssociationDes Moines, Iowa
  • Medical Oncology & Hematology Associates DBA Mission Cancer and BloodDes Moines, Iowa
  • Medical Oncology & Hematology Associates DBA Mission Cancer and BloodDes Moines, Iowa
  • Norton HospitalLouisville, Kentucky
  • Norton Cancer Institute, St. Matthews CampusLouisville, Kentucky
  • Norton Cancer Institute, AudubonLouisville, Kentucky
  • Norton Brownsboro HospitalLouisville, Kentucky
  • Norton Cancer Institute, Brownsboro CampusLouisville, Kentucky
  • Massachusetts General HospitalBoston, Massachusetts
  • Dana-Farber Cancer Institute - Chestnut HillNewton, Massachusetts
  • Memorial Sloan Kettering MonmouthMiddletown, New Jersey

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 6, 2026. Always confirm current availability with the study team.

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