Status:
ACTIVE_NOT_RECRUITING
A Study to Learn About the Study Medicine (Called PF-07220060 in Combination With PF-07104091) In Participants With Breast Cancer and Solid Tumors
Lead Sponsor:
Pfizer
Conditions:
Breast Cancer
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 p...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2026
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT05262400
Start Date
March 14 2022
End Date
August 23 2026
Last Update
November 18 2024
Active Locations (51)
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1
Administrative Address: UCLA Hematology/Oncology
Los Angeles, California, United States, 90095
2
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
3
UCLA Hematology/Oncology
Los Angeles, California, United States, 90095
4
UCLA Hematology / Oncology-Parkside
Santa Monica, California, United States, 90404