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New pfizer drug shows promise against tough cancers

NCT ID NCT04553133

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

157 people

The number who actually took part.

Started

Sep 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Centro de Investigaciones Medicas y Desarrollo LC

    Buenos Aires, Buenos Aires F.D., 1113, Argentina

  • Complex Oncology Center - Plovdiv EOOD

    Plovdiv, 4004, Bulgaria

  • Complex Oncology Center - Shumen

    Shumen, 9700, Bulgaria

  • Dana-Farber Cancer Institute - Chestnut Hill

    Newton, Massachusetts, 02459, United States

  • Des Moines Oncology Research Association

    Des Moines, Iowa, 50309, United States

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032, China

  • Laura & Isaac Perlmutter Cancer Center - NYU ACC

    New York, New York, 10016, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical Oncology & Hematology Associates DBA Mission Cancer and Blood

    Clive, Iowa, 50325, United States

  • Medical Oncology & Hematology Associates DBA Mission Cancer and Blood

    Des Moines, Iowa, 50309, United States

  • Medical Oncology & Hematology Associates DBA Mission Cancer and Blood

    Des Moines, Iowa, 50314, United States

  • Memorial Sloan Kettering Cancer Center (IDS Pharmacy)

    Long Island City, New York, 11101, United States

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748, United States

  • NYU Langone Medical Center (Tisch Hospital)

    New York, New York, 10016, United States

  • Norton Brownsboro Hospital

    Louisville, Kentucky, 40241, United States

  • Norton Cancer Institute, Audubon

    Louisville, Kentucky, 40217, United States

  • Norton Cancer Institute, Brownsboro Campus

    Louisville, Kentucky, 40241, United States

  • Norton Cancer Institute, St. Matthews Campus

    Louisville, Kentucky, 40207, United States

  • Norton Hospital

    Louisville, Kentucky, 40202, United States

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • UVA Breast Care Center

    Charlottesville, Virginia, 22911, United States

  • 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.