Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
- Conditions
- advanced or metastatic BC, prostate cancer or other solid tumor
- Registration Number
- JPRN-jRCT2031230121
- Lead Sponsor
- Kawai Norisuke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 337
Disease
* Part 1A/1D/1E: HR+HER2-BC, HR+HER2+BC, NSCLC, prostate cancer, CRC, liposarcoma, or tumors with previously confirmed CDK4 or CCND1 amplification according to local standard tests
* Part 1B/1C: HR+HER2-BC
* Part 1F: Prostate cancer
* Part 2A/2B/2C: HR+HER2-BC
* Part 2D: CRPC
Lesion
* Part 1: evaluable lesion (including skin or bone lesion only)
* Part 2A/2B/2C: measurable lesion per RECIST v1.1
* Part 2D: evaluable disease as per PCWG3; participants with bone metastases only are allowed. Participants with biochemical recurrence only are excluded
Prior systemic treatment
* Part 1: Refractory to or intolerant of existing standard therapies including CDK4/6i, HER2 targeting therapy or approved systemic therapy, or no standard therapy is available
* Part 2A: Must have at least 1 line of SOC, including prior CDK4/6i, for advanced/metastatic BC (Prior chemotherapies for advanced disease setting are allowed; Prior fulvestrant, mTOR and/or PI3K inhibitors are allowed)
* Part 2B: No 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 end of the prior aromatase inhibitor therapy for advanced/metastatic BC if postmenopausal or 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 treatment with abiraterone in any setting; No prior enzalutamide and CDK4/6i (up to 1 prior line of chemotherapy in any setting is allowed)
General inclusion criteria
* ECOG PS 0 or 1
* Adequate renal, liver, and bone marrow function
* 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method * Number of participants with DLT in the dose escalation portion [Time Frame: Baseline up to day 28 of Cycle 1] (Part 1A/1B/1C/1F)<br>* Incidence of clinically significant AEs, laboratory abnormalities and vital sign abnormalities [Time Frame: Weekly during Cycle 1 and 2 and then every 28 days through study completion, up to approximately 24 months; Each cycle is 28 days] (Part 1)<br>* Incidence of clinically significant abnormal ECG parameters [Time Frame: Day 1, Day 8, Day 15 of Cycle 1 and starting from Cycle 2, and then every 28 days through study completion, up to approximately 24 months (Each cycle is 28 days)] (Part 1)<br>* Food effect on PK parameters including Cmax, Tmax, AUC [Time Frame: Day -7 through the end of Cycle 1] (Part 1D)<br>* PF-07220060's effect on PK parameters of midazolam (CYP3A4 probe substrate) including Cmax, Tmax, AUC [Time Frame: Day -1 through the end of Cycle 1] (Part 1E)
- Secondary Outcome Measures
Name Time Method