Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors

Last updated: November 14, 2024
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

1/2

Condition

Prostate Cancer, Early, Recurrent

Prostate Cancer

Urologic Cancer

Treatment

Enzalutamide

Midazolam

PF-07220060

Clinical Study ID

NCT04557449
C4391001
2024-512120-11-00
2020-002938-33
  • Ages > 18
  • All Genders

Study Summary

This is a Phase 1/2A, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and then in combination with endocrine therapy.

The study consists of two parts and a China and Japan monotherapy cohort. Part 1 includes dose escalation cohorts evaluating PF-07220060 as single agent or in combination with endocrine therapy or enzalutamide, as well as a food effect cohort and a DDI cohort Part 2 includes dose expansion cohorts evaluating PF-07220060 in combination with endocrine therapy or enzalutamide.

In Part 1A, single escalating doses of PF-07220060 alone will be administered to determine the maximum tolerated dose (MTD) and select the recommended dose for expansion In Part 1B and Part 1C, PF-07220060 will be administered in combination with 1 of 2 endocrine therapies (letrozole and fulvestrant, respectively).

In Part 1D, food effect assessment of PF-07220060 at the RP2D dose level from the Part 1A will be conducted In Part 1E, the effect of PF-07220060 on the PK of midazolam will be evaluated (DDI) In Part 1F, escalating dosed of PF-07220060 will be administered in combination with enzalutamide Part 1B and Part 1C may commence at MTD or before reaching the MTD at a dose level in Part 1A.

Part 2A is a dose expansion cohort with fulvestrant and will explore more than one dose of PF-07220060 in participants diagnosed with mBC.

Part 2B and Part 2C are expansion for combination therapy of PF-07220060 with letrozole and fulvestrant, respectively.

Part 2D is the expansion cohort for combination therapy of PF-07220060 with enzalutamide.

Part 2E is an expansion cohort to evaluate PF-07220060 Monotherapy versus PF-07220060 plus fulvestrant combination therapy. The China monotherapy cohort will evaluate safety, tolerability and PK of PF-07220060 administered as single agent in Chinese participants.

The Japan monotherapy cohort will evaluate safety, tolerability and PK of PF-07220060 administered as a single agent in Japanese participants.

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Part 1: Breast Cancer (BC)

  • Refractory Hormone Receptor Positive (HR+), Human Epidermal Growth FactorReceptor 2 Negative (HER2-) BC

  • Part 1A/Part 1D/Part1E also include: Refractory HR-positive/HER2-positive BC

  • Part 1: Tumors other than BC (Part 1A/Part 1D/Part 1E): NSCLC, prostate, CRC,liposarcoma, or tumors with previously confirmed CDK4 or CCND1 amplificationaccording to local standard tests

  • Part 1F: prostate cancer

  • Part 2A, 2B, 2C and 2E:

  • HR-positive/HER2-negative BC

  • Patients who are either postmenopausal women or pre/peri-menopausal (Part 2Conly)

  • Part 1D: metastatic castration resistant prostate cancer

  • Lesion:

  • Part 1: evaluable lesion (including skin or bone lesion only)

  • Part 2A, 2B, 2C and 2E: measurable lesion per RECIST v1.1

  • Part 2D: Participants with evaluable disease as per PCWG3; participants withbone metastases only are allowed. Participants with biochemical recurrence onlyare excluded.

  • Prior systemic Treatment

  • Part 1: HR-positive/HER2-negative BC

  • At least 1 line of SOC, including CD4/6 inhibitor therapy for advanced ormetastatic disease, or if CDK4/6 inhibitors are not considered appropriatein the opinion of the investigator

  • At least 1 line of anti-endocrine in countries without CDK4/6 inhibitorapproval or reimbursement, for advanced or metastatic disease

  • HR-positive/HER2-positive BC (Parts 1A/1D/1E): at least 1 prior treatmentof approved HER2 targeting therapy

  • Tumors other than BC (Parts 1A/1D/1E/1F): tumor that is resistant to atleast 2 lines of SOC for advanced or recurrent disease or for which nostandard therapy is available

  • Part 2A and 2E: participants must have received at least 1 line of standard ofcare (including prior CDK4/6i) for advanced/metastatic disease; Prior chemo isallowed; Prior fulvestrant, mTOR and/or PI3K inhibitors are allowed

  • Part 2B: participants who have not received any prior systemic anti-cancertherapies for advanced/metastatic BC

  • Part 2C:

  • Progressed during treatment or within 12 months of completion of adjuvanttherapy with an aromatase inhibitor if postmenopausal, or tamoxifen if preor perimenopausal, or

  • Progressed while on or within 1 month after the endo the prior aromataseinhibitor therapy for advanced/metastatic BC if postmenopausal or priorendocrine treatment for advanced/metastatic BC if pre or perimenopausal

  • One previous line of chemotherapy for advanced/metastatic disease isallowed in addition to endocrine therapy

  • Part 2D:

  • Received prior abiraterone; enzalutamide and CDK4i naive

  • 0-1 line of chemotherapy is allowed General Inclusion Criteria

  • All participants must be refractory to or intolerant of existing therapies known toprovide clinical benefit for their condition.

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1

  • Adequate renal, liver, and bone marrow function

Exclusion

Exclusion Criteria:

  • Part 1D: participants who have had a gastrectomy or have dietary or otherrestrictions that preclude a 10 hour overnight fast or consumption of the high fat,high calorie meal

  • Part 2B: prior neoadjuvant or adjuvant treatment with a non-steroidal aromataseinhibitor with disease recurrence while on or within 12 months of completingtreatment. Prior treatment with any CDK4/6 inhibitor

  • Part 2C: prior treatment with any CDK inhibitor, fulvestrant, everolimus, or anyagent whose mechanism of action is to inhibit the PI3K-mTOR pathway

  • Known active uncontrolled or symptomatic Central Nervous System (CNS) metastasescarcinomatous meningitis, or leptomeningeal disease

  • Other active malignancy within 3 years prior to randomization, except for adequatelytreated basal cell or squamous cell skin cancer, or carcinoma in situ

  • Major surgery or radiation within 4 weeks prior to study intervention

  • Last anti-cancer treatment within 2 weeks prior to study intervention

  • Participation in other studies involving investigational drug(s) within 4 weeksprior to study entry

  • Pregnant or breastfeeding female participant

  • Active inflammatory gastrointestinal (GI) disease, known diverticular disease orprevious gastric resection or lap band surgery including impairment ofgastrointestinal function or GI disease

Study Design

Total Participants: 337
Treatment Group(s): 5
Primary Treatment: Enzalutamide
Phase: 1/2
Study Start date:
September 23, 2020
Estimated Completion Date:
November 23, 2027

Connect with a study center

  • Hospital Británico de Buenos Aires

    Ciudad autónoma de Buenos Aires, Buenos Aires 1280
    Argentina

    Active - Recruiting

  • Fundación Cenit Para La Investigación En Neurociencias

    Caba, Ciudad Autã³noma DE Buenos Aires 1125
    Argentina

    Active - Recruiting

  • Fundación Respirar

    Buenos Aires, C1426ABP
    Argentina

    Active - Recruiting

  • Clínica Universitaria Reina Fabiola

    Córdoba, X50004FHP
    Argentina

    Active - Recruiting

  • Fundación CORI para la Investigación y Prevención del Cáncer

    La Rioja, F5300COE
    Argentina

    Active - Recruiting

  • Cancer Hospital Chinese Academy of Medical Science

    Beijing, Beijing 100021
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan 450008
    China

    Active - Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei 430079
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shanxi 710061
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310016
    China

    Active - Recruiting

  • The first affiliated hospital of Ningbo University

    Ningbo, Zhejiang 315010
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00
    Czechia

    Active - Recruiting

  • Vseobecna fakultni nemocnice v Praze

    Praha 2, 12808
    Czechia

    Active - Recruiting

  • National Cancer Center Hospital East

    Kashiwa, Chiba 277-8577
    Japan

    Site Not Available

  • INCAN

    Cdmx, Distrito Federal 14080
    Mexico

    Active - Recruiting

  • Hospital MAC Periferico Sur

    Ciudad de Mexico, Distrito Federal 04700
    Mexico

    Active - Recruiting

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

    Mexico City, Distrito Federal
    Mexico

    Active - Recruiting

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo LEÓN 64460
    Mexico

    Active - Recruiting

  • Hospital Reforma

    Oaxaca de Juárez, Oaxaca 68000
    Mexico

    Active - Recruiting

  • Oaxaca Site Management Organization

    Oaxaca, 68000
    Mexico

    Active - Recruiting

  • Narodny onkologicky ustav

    Bratislava, 833 10
    Slovakia

    Active - Recruiting

  • Onkologicky ustav sv. Alzbety, s.r.o., Interna klinika VSZaSP a OUSA

    Bratislava, 812 50
    Slovakia

    Active - Recruiting

  • Fakultna nemocnica s poliklinikou Nove Zamky

    Nove Zamky, 940 34
    Slovakia

    Active - Recruiting

  • POKO Poprad, s.r.o.

    Poprad, 058 01
    Slovakia

    Active - Recruiting

  • Cancer Research UK Edinburgh Centre

    Edinburgh, Edinburgh, CITY OF EH4 2XR
    United Kingdom

    Active - Recruiting

  • St Bartholomew's Hospital

    London, London, CITY OF EC1A 7BE
    United Kingdom

    Active - Recruiting

  • Sarah Cannon Research Institute UK

    London, W1G 6AD
    United Kingdom

    Active - Recruiting

  • The Christie Hospital NHS Foundation Trust

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • Scottsdale Healthcare Hospitals dba HonorHealth

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • Ellison Institute

    Los Angeles, California 90064
    United States

    Site Not Available

  • Smilow Cancer Center at Yale New Haven-Hospital

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Smilow Cancer Hospital Phase 1 Unit

    New Haven, Connecticut 06511
    United States

    Active - Recruiting

  • Smilow Cancer Hospital at Yale - New Haven

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Yale-New Haven Hospital-Yale Cancer Center

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Brigham & Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute (DFCI)

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute- Chestnut Hill

    Newton, Massachusetts 02459
    United States

    Active - Recruiting

  • START Midwest

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • Tennessee Oncology PLLC

    Franklin, Tennessee 37067
    United States

    Site Not Available

  • Tennessee Oncology, PLLC

    Franklin, Tennessee 37067
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute - Pharmacy

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Tennessee Oncology, PLLC

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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