Breast Cancer Clinical Trial
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
Summary
This is a Phase 1, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and then in combination with endocrine therapy.
In Part 1A, single escalating doses of PF-07220060 alone will be administered to determine the maximum tolerated dose (MTD) and select the recommended phase 2 dose (RP2D).
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.
Part 1B and Part 1C may commence at MTD or before reaching the MTD at a dose level in Part 1A.
Part 2B and Part 2C are expansion for combination therapy of PF-07220060 with letrozole and fulvestrant, respectively.
Eligibility Criteria
Inclusion Criteria
Part 1: Breast Cancer (BC)
Refractory Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) BC
Part 1A/Part 1D also include: Refractory HR-positive/HER2-positive BC
Part 1: Tumors other than BC (Part 1A/Part 1D): NSCLC, prostate, CRC, liposarcoma, or tumors with previously confirmed CDK4 or CCND1 amplification according to local standard tests
Part 2:
HR-positive/HER2-negative BC
Patients who are either postmenopausal women or pre/peri-menopausal (Part 2C only)
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 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): at least 1 prior treatment of approved HER2 targeting therapy
Tumors other than BC (Parts 1A/1D): 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 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
General Inclusion Criteria
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 1D: participants who have had a gastrectomy or have dietary or other restrictions that preclude a 10 hour overnight fast or consumption of the high fat, high calorie meal
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
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There are 7 Locations for this study
New Haven Connecticut, 06510, United States
New Haven Connecticut, 06511, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Grand Rapids Michigan, 49546, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
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