Testing a new drug for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2A clinical trial evaluates the safety and tolerability of PF-07220060, a CDK4 inhibitor, in patients with advanced solid tumors, including breast cancer, prostate cancer, and liposarcoma. The study consists of two parts: the first part focuses on dose escalation to determine the maximum tolerated dose and the second part involves dose expansion with PF-07220060 used alone or in combination with endocrine therapies. Participants will be monitored for pharmacokinetics and pharmacodynamics to assess the drug's effects. The trial includes multiple cohorts, including those in China and Japan.

Why it matters

Who can join: the full rules

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/Part 1E 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 1G: HR-positive/HER2-negative BC
* Part 2A, 2B, 2C, 2E, and 2F: HR-positive/HER2-negative BC
* Part 1D: metastatic castration resistant prostate cancer
* Giredestrant Combination Cohort: ER-positive/HER2-negative BC
* 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
    * 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: 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: 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 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 1G and 2F: at least 2 lines of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy
  * Giredestrant Combination Cohort: at least 1 (no more than 3) prior line(s) of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and 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 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; Part 1G and 2F: tamoxifen treatment within 35 days of Day -4
* Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry
* Part 1G and 2F: history of or current pulmonary embolism or deep vein thrombosis
* Giredestrant Combination Cohort: history (within 6 months of screening) of or presence of idiopathic symptomatic bradycardia or resting heart rate \<50 bpm at screening
* 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's running

• Ellison Institute
  Los Angeles, California, United States Recruiting
• Smilow Cancer Hospital - Yale New Haven Health
  New Haven, Connecticut, United States Recruiting
• Yale-New Haven Hospital-Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• Smilow Cancer Hospital Phase 1 Unit
  New Haven, Connecticut, United States Recruiting
• Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP
  New Haven, Connecticut, United States Recruiting
• Smilow Cancer Hospital - Trumbull
  Trumbull, Connecticut, United States Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.