Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
NCT ID: NCT04557449
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
362 participants
INTERVENTIONAL
2020-09-23
2027-11-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Clinical Study of Chemoradiotherapy Sequential Fluzoparib in Pan-solid Tumors
NCT06055166
A Study of Envafolimab in Subjects With Stage III Non-Small Cell Lung Cancer
NCT05414630
A Study of FL115 Monotherapy in Unresectable or Metastatic Solid Tumors
NCT07131189
Study of Concurrent Chemo-radiotherapy Combined With Recombinant Human Endostatin for Local Advanced Non-small Cell Lung Cancer (NSCLC)
NCT01211002
A Study of ES014 in Subjects With Advanced Solid Tumors
NCT06543056
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1A Monotherapy Escalation Arm 1
PF-07220060 Monotherapy Escalation
PF-07220060
CDK4 inhibitor
1A Monotherapy Escalation Arm 2
PF-07220060 Monotherapy Escalation
PF-07220060
CDK4 inhibitor
1A Monotherapy Escalation Arm 3
PF-07220060 Monotherapy Escalation
PF-07220060
CDK4 inhibitor
1A Monotherapy Escalation Arm 4
PF-07220060 Monotherapy Escalation
PF-07220060
CDK4 inhibitor
1B Combination Dose Finding Arm 1
PF-07220060 with Letrozole combination Escalation
PF-07220060
CDK4 inhibitor
Letrozole
Endocrine Therapy
1B Combination Dose Finding Arm 2
PF-07220060 with Letrozole Combination Escalation
PF-07220060
CDK4 inhibitor
Letrozole
Endocrine Therapy
1C Combination Dose Finding Arm 1
PF-07220060 with Fulvestrant Combination Escalation
PF-07220060
CDK4 inhibitor
Fulvestrant
Endocrine Therapy
1C Combination Dose Finding Arm 2
PF-07220060 with Fulvestrant Combination Escalation
PF-07220060
CDK4 inhibitor
Fulvestrant
Endocrine Therapy
2B Combination Dose Expansion
PF-07220060 with Letrozole Combination Expansion
PF-07220060
CDK4 inhibitor
Letrozole
Endocrine Therapy
2C Combination Dose Expansion
PF-07220060 with fulvestrant Combination Expansion
PF-07220060
CDK4 inhibitor
Fulvestrant
Endocrine Therapy
1D Monotherapy Food Effect
PF-07220060 Monotherapy Food Effect
PF-07220060
CDK4 inhibitor
1A Monotherapy Escalation Arm 5
PF-07220060 Monotherapy Escalation
PF-07220060
CDK4 inhibitor
1F Combination Dose Finding
PF-07220060 with Enzalutamide Escalation
PF-07220060
CDK4 inhibitor
Enzalutamide
Androgen Receptor inhibitor
1E DDI Cohort
PF-07220060 DDI with Midazolam
PF-07220060
CDK4 inhibitor
Midazolam
Benzodiazepine used for DDI
2D Combination Dose Expansion
PF-07220060 with enzalutamide Combination Expansion
PF-07220060
CDK4 inhibitor
Enzalutamide
Androgen Receptor inhibitor
2A Combination Dose Expansion
PF-07220060 with fulvestrant combination dose expansion
PF-07220060
CDK4 inhibitor
Fulvestrant
Endocrine Therapy
2E Combination Dose Expansion
PF-07220060 Monotherapy OR PF-07220060 plus fulvestrant combination therapy
PF-07220060
CDK4 inhibitor
Fulvestrant
Endocrine Therapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PF-07220060
CDK4 inhibitor
Letrozole
Endocrine Therapy
Fulvestrant
Endocrine Therapy
Midazolam
Benzodiazepine used for DDI
Enzalutamide
Androgen Receptor inhibitor
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Refractory Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 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 amplification according 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 2C only)
* 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 with bone metastases only are allowed. Participants with biochemical recurrence only are excluded.
* Prior systemic Treatment
* Part 1: HR-positive/HER2-negative BC
* At least 1 line of SOC, including CD4/6 inhibitor therapy for advanced or metastatic disease, or if CDK4/6 inhibitors are not considered appropriate in the opinion of the investigator
* At least 1 line of anti-endocrine in countries without CDK4/6 inhibitor approval or reimbursement, for advanced or metastatic disease
* HR-positive/HER2-positive BC (Parts 1A/1D/1E): at least 1 prior treatment of approved HER2 targeting therapy
* Tumors other than BC (Parts 1A/1D/1E/1F): tumor that is resistant to at least 2 lines of SOC for advanced or recurrent disease or for which no standard therapy is available
* Part 2A and 2E: participants must have received at least 1 line of standard of care (including prior CDK4/6i) for advanced/metastatic disease; Prior chemo is allowed; Prior fulvestrant, mTOR and/or PI3K inhibitors are allowed
* Part 2B: participants who have not received any prior systemic anti-cancer therapies for advanced/metastatic BC
* Part 2C:
* Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre or perimenopausal, or
* Progressed while on or within 1 month after the endo the prior aromatase inhibitor therapy for advanced/metastatic BC if postmenopausal or prior endocrine treatment for advanced/metastatic BC if pre or perimenopausal
* One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy
* Part 2D:
* Received prior abiraterone; enzalutamide and CDK4i naive
* All participants must be refractory to or intolerant of existing therapies known to provide clinical benefit for their condition.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
* Adequate renal, liver, and bone marrow function
Exclusion Criteria
* Part 2B: prior neoadjuvant or adjuvant treatment with a non-steroidal aromatase inhibitor with disease recurrence while on or within 12 months of completing treatment. Prior treatment with any CDK4/6 inhibitor
* Part 2C: prior treatment with any CDK inhibitor, fulvestrant, everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway
* Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases carcinomatous meningitis, or leptomeningeal disease
* Other active malignancy within 3 years prior to randomization, except for adequately treated 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 weeks prior to study entry
* Pregnant or breastfeeding female participant
* Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastrointestinal function or GI disease
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ellison Institute
Los Angeles, California, United States
Smilow Cancer Hospital at Yale - New Haven
New Haven, Connecticut, United States
Yale-New Haven Hospital-Yale Cancer Center
New Haven, Connecticut, United States
Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Dana Farber Cancer Institute- Chestnut Hill
Newton, Massachusetts, United States
START Midwest
Grand Rapids, Michigan, United States
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Hospital Británico de Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Fundación Cenit Para La Investigación En Neurociencias
CABA, Ciudad Autã³noma de Buenos Aires, Argentina
Fundación Respirar
Buenos Aires, , Argentina
Clínica Universitaria Reina Fabiola
Córdoba, , Argentina
Fundación CORI para la Investigación y Prevención del Cáncer
La Rioja, , Argentina
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Hospital MAC Periferico Sur
Mexico City, Mexico City, Mexico
INCAN
Mexico City, Mexico City, Mexico
COI Centro Oncologico Internacional S.A.P.I. de C.V.
Mexico City, Mexico City, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico
Hospital Reforma
Oaxaca City, Oaxaca, Mexico
Oaxaca Site Management Organization
Oaxaca City, , Mexico
Onkologicky ustav sv. Alzbety, s.r.o., Interna klinika VSZaSP a OUSA
Bratislava, , Slovakia
Narodny onkologicky ustav
Bratislava, , Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky
Nové Zámky, , Slovakia
POKO Poprad, s.r.o.
Poprad, , Slovakia
Cancer Research UK Edinburgh Centre
Edinburgh, Edinburgh, CITY of, United Kingdom
St Bartholomew's Hospital
London, London, CITY of, United Kingdom
Sarah Cannon Research Institute UK
London, , United Kingdom
The Christie Hospital NHS Foundation Trust
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-512120-11-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C4391001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.