PF-07104091 as a Single Agent and in Combination Therapy

Last updated: May 14, 2024
Sponsor: Pfizer
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Small Cell Lung Cancer

Breast Cancer

Ovarian Cancer

Treatment

PF-07104091 monotherapy dose expansion (SCLC)

PF-07104091 + palbociclib + fulvestrant

PF-07104091 monotherapy dose escalation

Clinical Study ID

NCT04553133
C4161001
2022-001679-15
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 includingone prior line of combined CDK4/6 inhibitor and endocrine therapy and no more thantwo prior lines of cytotoxic chemotherapy)

  • Participants with locally recurrent/advanced or metastatic TNBC who have received upto 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 orcytologically proven) who have received at least 1 systemic anti-cancer therapycontaining 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 measurablelesion 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

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 mayaffect participant safety or interpretation of study results

  • Any of the following in the previous 6 months: myocardial infarction, long QTsyndrome, Torsade de Pointes, arrhythmias, serious conduction system abnormalities,unstable angina, coronary/peripheral artery bypass graft, symptomatic CHF, New YorkHeart Association class III or IV, cerebrovascular accident, transient ischemicattack, symptomatic pulmonary embolism, and/or other clinical significant episode ofthrombo 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 weeksprior to study entry.

  • Known or suspected hypersensitivity to active ingredient/excipients in PF 07104091.

  • Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticulardisease or previous gastric resection or lap band surgery.

  • Participants with advanced/metastatic, symptomatic, visceral spread, that are atrisk of life threatening complications in the short

  • Participants with an indwelling catheter that has an external component such asthose 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 withanticoagulants precluding intramuscular injections of goserelin (if applicable).

  • Current use or anticipated need for food or drugs that are known strong CYP3A4/5 orUGT1A9 inhibitors or inducers

  • Current use or anticipated need for drugs that are known sensitive UGT1A1 substrateswith narrow therapeutic

  • Serum pregnancy test positive at screening

  • Other medical or psychiatric condition

Study Design

Total Participants: 154
Treatment Group(s): 7
Primary Treatment: PF-07104091 monotherapy dose expansion (SCLC)
Phase: 1/2
Study Start date:
September 16, 2020
Estimated Completion Date:
March 06, 2025

Study Description

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.

Connect with a study center

  • Centro Oncologico Korben

    Caba, Buenos Aires C1426AGE
    Argentina

    Site Not Available

  • Fundación Cenit Para La Investigación En Neurociencias

    Caba, Ciudad Autónoma DE Buenos Aires 1125
    Argentina

    Site Not Available

  • Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan

    San Juan, 5400
    Argentina

    Site Not Available

  • Specialized Hospital for Active Treatment of Oncology - Haskovo

    Haskovo, 6300
    Bulgaria

    Site Not Available

  • Complex Oncology Center - Plovdiv EOOD

    Plovdiv, 4004
    Bulgaria

    Site Not Available

  • Complex Oncology Center - Shumen

    Shumen, 9700
    Bulgaria

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan 450008
    China

    Site Not Available

  • Jilin Province Cancer Hospital

    Changchun, Jilin 130000
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin 300060
    China

    Site Not Available

  • National Cancer Center Hospital East

    Kashiwa, Chiba 277-8577
    Japan

    Site Not Available

  • The Cancer Institute Hospital of JFCR

    Koto, Tokyo 135-8550
    Japan

    Site Not Available

  • COI Centro Oncologico Internacional S.A.P.I. de C.V.

    Mexico City, Distrito Federal 04700
    Mexico

    Site Not Available

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo LEÓN 64460
    Mexico

    Site Not Available

  • Oaxaca Site Management Organization

    Oaxaca, 68000
    Mexico

    Site Not Available

  • Medical Oncology & Hematology Associates DBA Mission Cancer and Blood

    Clive, Iowa 50325
    United States

    Site Not Available

  • Des Moines Oncology Research Association

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • Medical Oncology & Hematology Associates DBA Mission Cancer and Blood

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • Norton Brownsboro Hospital

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Norton Cancer Institute Downtown

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Norton Cancer Institute Pharmacy, Downtown Pharmacy

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Norton Cancer Institute, Audubon

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Norton Cancer Institute, Brownsboro Campus

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Norton Cancer Institute, Downtown

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Norton Cancer Institute, St. Matthews

    Louisville, Kentucky 40207
    United States

    Site Not Available

  • Norton Diagnostic Center - Fern Creek

    Louisville, Kentucky 40291
    United States

    Site Not Available

  • Norton Hospital

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Norton Hospital (Audubon)

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Norton Women's and Children's Hospital (St. Matthews)

    Louisville, Kentucky 40207
    United States

    Site Not Available

  • Brigham & Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Dana-Farber Cancer Institute - Chestnut Hill

    Newton, Massachusetts 02459
    United States

    Site Not Available

  • START Midwest

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey 07748
    United States

    Site Not Available

  • Memorial Sloan Kettering Westchester

    Harrison, New York 10604
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center (IDS Pharmacy)

    Long Island City, New York 11101
    United States

    Site Not Available

  • NYU Langone Hospital - Long Island

    Mineola, New York 11501
    United States

    Site Not Available

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    Mineola, New York 11501
    United States

    Site Not Available

  • Laura & Isaac Perlmutter Cancer Center - NYU ACC

    New York, New York 10016
    United States

    Site Not Available

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • MSK Rockefeller Outpatient Pavilion

    New York, New York 10022
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • NYU Langone Medical Center (Tisch Hospital)

    New York, New York 10016
    United States

    Site Not Available

  • White Plains Hospital

    White Plains, New York 10601
    United States

    Site Not Available

  • Tennessee Oncology PLLC

    Franklin, Tennessee 37067
    United States

    Site Not Available

  • The Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • UVA Breast Care Center

    Charlottesville, Virginia 22911
    United States

    Site Not Available

  • University of Virginia Cancer Center

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • University of Virginia Health System

    Charlottesville, Virginia 22908
    United States

    Site Not Available

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