We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05262400
Recruitment Status : Recruiting
First Posted : March 2, 2022
Last Update Posted : May 22, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Breast Cancer Solid Tumors Drug: PF-07220060 + PF-07104091 combination dose escalation Drug: PF-07104091 + PF-07220060 + fulvestrant dose expansion Drug: PF-07104091 + PF-07220060 + letrozole dose expansion Phase 1 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE 1B/2, OPEN-LABEL, MULTICENTER, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTITUMOR ACTIVITY OF PF-07220060 IN COMBINATION WITH PF-07104091 PLUS ENDOCRINE THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
Actual Study Start Date : March 14, 2022
Estimated Primary Completion Date : July 23, 2026
Estimated Study Completion Date : July 23, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Part 1 Dose Escalation - Dose Level 1
PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)
 Drug: PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
Experimental: Part 1 Dose Escalation - Dose Level 2
PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)
 Drug: PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
Experimental: Part 1 Dose Escalation - Dose Level 3
PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)
 Drug: PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
Experimental: Part 1 Dose Escalation - Dose Level 4
PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)
 Drug: PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
Experimental: Part 1 Dose Escalation - Dose Level 5
PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)
 Drug: PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
Experimental: Part 2A
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
PF-07104091 and PF-07220060 will be administered orally in combination with fulvestrant
Experimental: Part 2B
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
PF-07104091 and PF-07220060 will be administered orally in combination with fulvestrant
Experimental: Part 2C
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
PF-07104091 and PF-07220060 will be administered orally in combination with letrozole
Experimental: Part 1 Dose Escalation - Dose Level 6
PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)
 Drug: PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
Experimental: Part 1 Dose Escalation - Dose Level 7
PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)
 Drug: PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
Experimental: Part 1 Dose Escalation - Dose Level 8
PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)
 Drug: PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) during first cycle [ Time Frame: Cycle 1 (28 days) ]
    Number of participants with DLTs, which are typically Grade 3 or higher adverse events will be summarized by dose level

  2. Number of participants with treatment emergent adverse events (AEs) [ Time Frame: From baseline until end of study treatment or study completion (approximately 2 years) ]
  3. Incidence of participants with clinical laboratory abnormalities [ Time Frame: From baseline until end of study treatment or study completion (approximately 2 years) ]
  4. Number of participants with vital signs abnormalities [ Time Frame: From baseline until end of study treatment or study completion (approximately 2 years) ]
  5. Number of participants with corrected QT (QTc) interval [ Time Frame: From baseline until end of study treatment or study completion (approximately 2 years) ]
    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


Secondary Outcome Measures :
  1. Maximum plasma concentration (Cmax) of PF-07220060 and PF-07104091 together after a single dose and multiple dose [ Time Frame: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days) ]
  2. Time to maximum plasma concentration (Tmax) of PF-07220060 and PF-07104091 together after a single dose and multiple dose [ Time Frame: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days) ]
  3. 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 [ Time Frame: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days) ]
  4. Objective response rate (ORR) of PF-07220060 and PF-07104091 together in dose escalation and together in combination with fulvestrant or letrozole [ Time Frame: From baseline through disease progression or study completion (approximately 2 years) ]
    Percentage of participants with a best ORR of complete response (CR) or partial response (PR) using RECIST 1.

  5. 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 [ Time Frame: From baseline through time to event on study or study completion (approximately 2 years) ]
    Time from first assessment of event endpoint to last assessment of using RECIST 1.1

  6. Duration of Response (DoR) of PF-07220060 and PF-07104091 together in dose escalation and together in combination with fulvestrant or letrozole [ Time Frame: From baseline through time to event on study or study completion (approximately 2 years) ]
    DoR is defined as the time from first documentation of CR or PR to date of first documentation of progressive disease/pharmacodynamic (PD) or death due to any cause, whichever occurs first

  7. Progression-Free Survival (PFS) of PF-07220060 and PF-07104091 together in dose escalation and together in combination with fulvestrant or letrozole [ Time Frame: From baseline through time to event on study or study completion (approximately 2 years) ]
    PFS is defined as time from start date of treatment to the date of first documentation of PD or death due to any cause

  8. Time to Progression (TTP) of PF-07220060 and PF-07104091 together in dose escalation and together in combination with fulvestrant or letrozole [ Time Frame: From baseline through time to event on study or study completion (approximately 2 years) ]
    TTP is defined as the time from start date of treatment to the date of the first documentation of PD


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05262400


Contacts
Layout table for location contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Show Show 22 study locations
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05262400    
Other Study ID Numbers: C4391002
2022-002173-28 ( EudraCT Number )
First Posted: March 2, 2022    Key Record Dates
Last Update Posted: May 22, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
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-)
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Fulvestrant
Antineoplastic Agents
Aromatase Inhibitors
 Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Estrogen Receptor Antagonists