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Clinical Trials in China / NCT05262400
Active, not recruiting Phase 1/2

A Study to Learn About the Study Medicine (Called PF-07220060 in Combination With PF-07104091) In Participants With Breast Cancer and Solid Tumors

NCT05262400 · tracked via the Priya Life Science China tracker
Sponsor
Pfizer
Phase
Phase 1/2
Started
2022-03-14
Last updated
2026-09-14

Condition(s) studied

Breast CancerSolid Tumors

Investigational drug(s) / intervention(s)

PF-07220060 + PF-07104091 combination dose escalation →PF-07220060 + PF-07104091 combination dose escalation →PF-07220060 + PF-07104091 combination dose escalation →PF-07220060 + PF-07104091 combination dose escalation →PF-07220060 + PF-07104091 combination dose escalation →PF-07104091 + PF-07220060 + fulvestrant dose expansionAll PF-07104091 trials (2) →All PF-07220060 trials (6) →PF-07104091 + PF-07220060 + fulvestrant dose expansionAll PF-07104091 trials (2) →All PF-07220060 trials (6) →PF-07104091 + PF-07220060 + letrozole dose expansionAll PF-07104091 trials (2) →All PF-07220060 trials (6) →PF-07220060 + PF-07104091 combination dose escalation →PF-07220060 + PF-07104091 combination dose escalation →PF-07220060 + PF-07104091 combination dose escalation →

PF-07220060 + PF-07104091 combination dose escalation: PF-07104091 and PF-07220060 will be administered orally

PF-07220060 + PF-07104091 combination dose escalation: PF-07104091 and PF-07220060 will be administered orally

PF-07220060 + PF-07104091 combination dose escalation: PF-07104091 and PF-07220060 will be administered orally

PF-07220060 + PF-07104091 combination dose escalation: PF-07104091 and PF-07220060 will be administered orally

PF-07220060 + PF-07104091 combination dose escalation: PF-07104091 and PF-07220060 will be administered orally

PF-07104091 + PF-07220060 + fulvestrant dose expansion: PF-07104091 and PF-07220060 will be administered orally in combination with fulvestrant

PF-07104091 + PF-07220060 + fulvestrant dose expansion: PF-07104091 and PF-07220060 will be administered orally in combination with fulvestrant

PF-07104091 + PF-07220060 + letrozole dose expansion: PF-07104091 and PF-07220060 will be administered orally in combination with letrozole

PF-07220060 + PF-07104091 combination dose escalation: PF-07104091 and PF-07220060 will be administered orally

PF-07220060 + PF-07104091 combination dose escalation: PF-07104091 and PF-07220060 will be administered orally

PF-07220060 + PF-07104091 combination dose escalation: PF-07104091 and PF-07220060 will be administered orally

Study summary

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07220060 and PF-07104091) in people with breast cancer. This clinical study consists of 2 parts (part 1 and part 2). In part 1, we are seeking participants who:

* Have been diagnosed with Breast Cancer (BC) of either types:
* Have HR+, HER2- BC
* Refractory HR-positive/HER2-positive BC
* Have other solid tumors other than BC

In part 2, we are seeking participants who:

-Have HR-positive/HER2-negative BC Part 1 will include increasing doses of PF-07220060 with PF-07104091. In part 2, participants will take 1 of 2 study medicine combinations. This will help us decide the highest amount of study medicines that can be safety given to people. All participants in this study will receive PF-07220060 with PF-07104091 by mouth. We will compare participant experiences to help us determine if PF-07220060 with PF-07104091 is safe and effective. Participants will take part in this study for about 2 years. During this time, they will receive the study medicine, an x-ray imaging, and will be observed for safety and effects of the study medicines.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria * Part 1: Breast Cancer (BC) * HR+, HER2- BC * Refractory HR-positive/HER2-positive BC * Part 1: Solid Tumors other than BC * Part 2: * HR-positive/HER2-negative BC * Lesion: * Part 1: evaluable lesion (including skin or bone lesion only) * Part 2: measurable lesion per RECIST v1.1 * Prior systemic Treatment * Part 1: HR-positive/HER2-negative BC * At least 1 line of SOC, including CDK4/6 inhibitor therapy and Endocrine Therapy, for advanced or metastatic disease. * Prior chemotherapy in the metastatic setting is allowed. * Part 1: HR-positive/HER2-positive BC * At least 1 prior treatment of approved HER2 targeting therapy. * Part 1: Solid Tumors other than BC * Participants with no standard therapy available or for which no local regulatory approved standard therapy is available that would confer significant clinical benefit in the medical judgement of the investigator. * Part 2A: At least 1 prior systemic therapy for advanced or metastatic disease, including CDK4/6 inhibitor treatment and ET. * Parts 2B: At least 1 prior endocrine therapy for advanced or metastatic disease. Progression during treatment or within 12 months of completion of adjuvant endocrine therapy is acceptable. * Part 2B: Up to 1 prior line of chemotherapy for advanced/metastatic disease is allowed. * General Inclusion Criteria * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1 * Adequate renal, liver, and bone marrow function * Resolved acute effects of any prior therapy to baseline severity Exclusion Criteria: * All Study Parts: Permanent treatment discontinuation from prior CDK 4 and/or CDK2 inhibitor due to treatment related toxicity. * Part 2B and 1C: Prior treatment with any CDK 4/6 inhibitor, or SERDs (e.g. fulvestrant), or everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway for advanced disease. * Parts 2B and 2C: Prior treatment with any CDK4/6 inhibitor for advanced disease. * Parts 2B and 2C: Prior treatment with an investigational endocrine therapy for advanced disease. * Part 2C: Prior neoadjuvant or adjuvant treatment with a nonsteroidal aromatase inhibitor AI (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment. * Part 2C: Any prior systemic treatment for advanced disease. * Prior irradiation to \>25% of the bone marrow * Current use of drugs which have a risk for QTc prolongation * Current use or anticipated need for food or drugs that are known strong CYP3A4/5, strong UGT2B7 or UGT1A9 inhibitors or inducers * Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry * Participants with any other active malignancy within 3 years prior to enrollment except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix, Bowen's disease * Major surgery within 4 weeks prior to study entry * Radiation therapy within 4 weeks prior to study entry. * Clinically important hypertension * Known or suspected hypersensitivity to PF-07220060, PF-07104091, letrozole, fulvestrant, or goserelin (or equivalent to induce chemical menopause if applicable) * Known abnormalities in coagulation. Anticoagulation with subcutaneous heparin or prophylactic doses of anticoagulant are allowed * Known active uncontrolled or symptomatic central nervous system (CNS) metastases * Active inflammatory GI disease * Current use or anticipated need for Proton Pump Inhibitors (PPI) within 14 days prior to first dose of the study intervention * Previous high-dose chemotherapy requiring stem cell rescue * Participants with active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), and known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness * Other protocol specific exclusion criteria may apply

Primary outcome measure(s)

Trial sites (44)

FacilityCityRegionStatus
Administrative Address: UCLA Hematology/Oncology Los Angeles California
Ronald Reagan UCLA Medical Center Los Angeles California
UCLA Hematology/Oncology Los Angeles California
UCLA Hematology / Oncology-Parkside Santa Monica California
UCLA Hematology/Oncology-Santa Monica Santa Monica California
Massachusetts General Hospital Boston Massachusetts
START Midwest Grand Rapids Michigan
Saint Luke's Cancer Institute Kansas City Missouri
Texas Oncology-Baylor Charles A. Sammons Cancer Center Dallas Texas
The University of Texas MD Anderson Cancer Center Houston Texas
Swedish Medical Center Seattle Washington
Swedish Medical Center Seattle Washington
Clinica Viedma S. A Viedma Río Negro Province
Centro Oncologico Korben Buenos Aires Argentina
Clínica Universitaria Reina Fabiola Córdoba Argentina
Fundación CORI para la Investigación y Prevención del Cáncer La Rioja Argentina
ONCOSITE - Centro de Pesquisa Clinica em Oncologia Ijuí Rio Grande do Sul
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa Porto Alegre Rio Grande do Sul
Centro de Pesquisa Clínica - Área Administrativa Porto Alegre Rio Grande do Sul
Fundação Pio XII - Hospital de Câncer de Barretos Barretos São Paulo
Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda São Paulo Brazil
Multiprofile Hospital for Active Treatment Serdikamed EOOD Sofia Sofia (stolitsa)
Specialized Hospital for Active Treatment of Oncology - Haskovo Haskovo Bulgaria
Complex Oncology Center - Plovdiv EOOD Plovdiv Bulgaria
Complex Oncology Center - Vratsa Vratsa Bulgaria
The First Hospital of Jilin University Changchun Jilin
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality
West China Hospital, Sichuan University Chengdu Sichuan
Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin Municipality
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang
Fakultni nemocnice Olomouc Olomouc Olomouc Region
Fakultni nemocnice Bulovka Prague Praha 8
Vseobecna fakultni nemocnice v Praze Prague Czechia
Všeobecná fakultní nemocnice v Praze Prague Czechia
Instituto Nacional de Cancerologia Mexico City Mexico City
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey Nuevo León
Mérida Investigación Clínica Mérida Yucatán
FARMOVS Bloemfontein Free State
Wits Clinical Research Johannesburg Gauteng
Hospital Universitari Vall d'Hebron Barcelona Barcelona [barcelona]

+ 4 more sites — see the full list on the official registry below.

More Pfizer trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05262400 on ClinicalTrials.gov ↗ ← All trials in China