Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors

Running, not enrolling · Phase 2

Conditions studied: Liposarcoma, Prostate Cancer, Breast Neoplasms, Adenocarcinoma of Lung

In brief

This is a Phase 1/2A, 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. 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.

Key facts

Study ID

NCT04557449

Run by

Pfizer

People needed

362

Starts

2020-09-23

Expected to finish

2027-11-23

Last updated by the study team

2025-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Part 1: Breast Cancer (BC)
• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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