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

Launched by PFIZER · Sep 15, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called PF-07220060 for patients with advanced solid tumors, including specific types of breast cancer, prostate cancer, lung cancer, and liposarcoma. The main goal of the trial is to find out how safe PF-07220060 is and how well it can be tolerated by patients. The study is divided into two parts: the first part tests different doses of the treatment alone and in combination with other therapies, while the second part focuses on expanding the study to see how effective the treatment is when combined with existing hormone therapies.

To be eligible for the trial, participants typically need to have cancers that have not responded to standard treatments and must meet certain health criteria. For instance, they should have a specific type of breast cancer that has not responded to previous therapies, or advanced prostate cancer that has also been resistant to other treatments. Participants will receive the study drug and will be monitored closely for safety and any side effects. This trial is currently recruiting patients, and it offers an opportunity for those who have limited treatment options to potentially benefit from a new therapy.

Gender

ALL

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/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
• • 0-1 line of chemotherapy is allowed 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