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 | Active Not Recruiting Phase 1 FDA Drug

• 3 other identifiers: C43910022022-002173-282023-509504-15-00
• Study Type: interventional
• Target: 192
• Locations: 9 countries
• Sites: 51

Brief 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.

Conditions

Breast Cancer; Solid Tumors

Keywords

cyclin-dependent kinase 2 (CDK2); cyclin-dependent kinase 4 (CDK4); estrogen receptor-positive/human epidermal growth factor receptor 2 negative (ER+/HER2-); estrogen receptor-positive/refractory hormone receptor positive (ER+/HER2+); hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-)

Outcome Measures

Primary Outcomes (5)

• Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) during first cycle

  Number of participants with DLTs, which are typically Grade 3 or higher adverse events will be summarized by dose level

  Cycle 1 (28 days)

• Number of participants with treatment emergent adverse events (AEs)

  From baseline until end of study treatment or study completion (approximately 2 years)

• Incidence of participants with clinical laboratory abnormalities

  From baseline until end of study treatment or study completion (approximately 2 years)

• Number of participants with vital signs abnormalities

  From baseline until end of study treatment or study completion (approximately 2 years)

• Number of participants with corrected QT (QTc) interval

  Determine the effect of the drug on QT prolongation. The number and percentage of participants who experienced QT interval prolongation will be summarized by dose level

  From baseline until end of study treatment or study completion (approximately 2 years)

Secondary Outcomes (8)

• Maximum plasma concentration (Cmax) of PF-07220060 and PF-07104091 together after a single dose and multiple dose

  Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)

• Time to maximum plasma concentration (Tmax) of PF-07220060 and PF-07104091 together after a single dose and multiple dose

  Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)

• Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-07220060 and PF-07104091 together

  Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)

• Objective response rate (ORR) of PF-07220060 and PF-07104091 together in dose escalation and together in combination with fulvestrant or letrozole

  From baseline through disease progression or study completion (approximately 2 years)

• To evaluate the preliminary antitumor activity of PF-07220060 and PF-07104091 together in dose escalation and together in combination with fulvestrant or letrozole by time to event endpoints

  From baseline through time to event on study or study completion (approximately 2 years)

Study Arms (11)

Part 1 Dose Escalation - Dose Level 1

EXPERIMENTAL

PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)

Drug: PF-07220060 + PF-07104091 combination dose escalation

Part 1 Dose Escalation - Dose Level 2

EXPERIMENTAL

PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)

Drug: PF-07220060 + PF-07104091 combination dose escalation

Part 1 Dose Escalation - Dose Level 3

EXPERIMENTAL

PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)

Drug: PF-07220060 + PF-07104091 combination dose escalation

Part 1 Dose Escalation - Dose Level 4

EXPERIMENTAL

PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)

Drug: PF-07220060 + PF-07104091 combination dose escalation

Part 1 Dose Escalation - Dose Level 5

EXPERIMENTAL

PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)

Drug: PF-07220060 + PF-07104091 combination dose escalation

Part 2A

EXPERIMENTAL

PF-07220060 + PF-07104091 + Fulvestrant (ER+/HER2- Breast Cancer with at least 1 prior systemic therapy for advanced or metastatic disease, including CDK4/6 inhibitor treatment and Endocrine Therapy)

Drug: PF-07104091 + PF-07220060 + fulvestrant dose expansion

Part 2B

EXPERIMENTAL

PF-07220060 + PF-07104091 + Fulvestrant (ER+/HER2- Breast Cancer with at least 1 prior endocrine therapy and up to 1 prior line of chemotherapy for advanced or metastatic disease and no prior treatment with any CDK4/6 inhibitor for advanced disease)

Drug: PF-07104091 + PF-07220060 + fulvestrant dose expansion

Part 2C

EXPERIMENTAL

PF-07220060 + PF-07104091 + Letrozole (ER+/HER2- Breast Cancer with no prior treatment with any CDK4/6 inhibitor for advanced disease)

Drug: PF-07104091 + PF-07220060 + letrozole dose expansion

Part 1 Dose Escalation - Dose Level 6

EXPERIMENTAL

PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)

Drug: PF-07220060 + PF-07104091 combination dose escalation

Part 1 Dose Escalation - Dose Level 7

EXPERIMENTAL

PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)

Drug: PF-07220060 + PF-07104091 combination dose escalation

Part 1 Dose Escalation - Dose Level 8

EXPERIMENTAL

PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)

Drug: PF-07220060 + PF-07104091 combination dose escalation

Interventions

PF-07220060 + PF-07104091 combination dose escalation DRUG

PF-07104091 and PF-07220060 will be administered orally

Part 1 Dose Escalation - Dose Level 1

PF-07104091 + PF-07220060 + fulvestrant dose expansion DRUG

PF-07104091 and PF-07220060 will be administered orally in combination with fulvestrant

Part 2A

PF-07104091 + PF-07220060 + letrozole dose expansion DRUG

PF-07104091 and PF-07220060 will be administered orally in combination with letrozole

Part 2C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (51)

Administrative Address: UCLA Hematology/Oncology

Los Angeles, California, 90095, United States

Location

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

UCLA Hematology/Oncology

Los Angeles, California, 90095, United States

Location

UCLA Hematology / Oncology-Parkside

Santa Monica, California, 90404, United States

Location

UCLA Hematology/Oncology-Santa Monica

Santa Monica, California, 90404, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

START Midwest

Grand Rapids, Michigan, 49546, United States

Location

Saint Luke's Cancer Institute

Kansas City, Missouri, 64111, United States

Location

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Swedish Medical Center

Seattle, Washington, 98104, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Clinica Viedma S. A

Viedma, Río Negro Province, R8500ACE, Argentina

Location

Centro Oncologico Korben

Buenos Aires, 1426, Argentina

Location

Clínica Universitaria Reina Fabiola

Córdoba, X50004FHP, Argentina

Location

Fundación CORI para la Investigación y Prevención del Cáncer

La Rioja, F5300COE, Argentina

Location

ONCOSITE - Centro de Pesquisa Clinica em Oncologia

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa

Porto Alegre, Rio Grande do Sul, 90110-270, Brazil

Location

Centro de Pesquisa Clínica - Área Administrativa

Porto Alegre, Rio Grande do Sul, 90850-170, Brazil

Location

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo, 14784400, Brazil

Location

Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda

São Paulo, 01317-000, Brazil

Location

Multiprofile Hospital for Active Treatment Serdika EOOD

Sofia, Sofia (stolitsa), 1632, Bulgaria

Location

Specialized Hospital for Active Treatment of Oncology - Haskovo

Haskovo, 6300, Bulgaria

Location

Complex Oncology Center - Plovdiv EOOD

Plovdiv, 4004, Bulgaria

Location

Multiprofile Hospital for Active Treatment Serdika EOOD

Sofia, 1303, Bulgaria

Location

Complex Oncology Center - Vratsa

Vratsa, 3000, Bulgaria

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Location

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016, China

Location

Fakultni nemocnice Olomouc

Olomouc, Olomoucký kraj, 779 00, Czechia

Location

Fakultni nemocnice Bulovka

Prague, Praha 8, 180 81, Czechia

Location

Vseobecna fakultni nemocnice v Praze

Prague, 12808, Czechia

Location

Instituto Nacional de Cancerologia

Mexico City, Mexico City, 14080, Mexico

Location

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, 64460, Mexico

Location

Mérida Investigación Clínica

Mérida, Yucatán, 97125, Mexico

Location

FARMOVS

Bloemfontein, Free State, 9301, South Africa

Location

15 Eton Road

Johannesburg, Gauteng, 2193, South Africa

Location

Charlotte Maxeke Johannesburg Academic Hospital

Johannesburg, Gauteng, 2193, South Africa

Location

WCR Office

Johannesburg, Gauteng, 2193, South Africa

Location

Wits Clinical Research

Johannesburg, Gauteng, 2193, South Africa

Location

Wilgers Oncology Centre

Pretoria, Gauteng, 0040, South Africa

Location

CHUS - Hospital Clinico Universitario

Santiago de Compostela, A Coruña [LA Coruña], 15706, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [barcelona], 08035, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Catalunya [cataluña], 08036, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de, 28041, Spain

Location

Hospital Universitario HM Sanchinarro

Madrid, Madrid, Comunidad de, 28050, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 2, 2022
• Study Start: March 14, 2022
• Primary Completion (Estimated): August 23, 2026
• Study Completion (Estimated): August 23, 2026
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

BR (5); CN (7); ME (3); BU (5); CZ (3); AR (4); ZA (6); ES (6); US (12)