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Testing a new drug for advanced solid tumors

A PHASE 1/2A STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-07220060 AS A SINGLE AGENT AND AS PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS

PHASE1 · Pfizer · NCT04557449

This study is testing a new drug for people with advanced solid tumors, like breast or prostate cancer, to see how safe it is and how well it works on its own or with other treatments.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment337 (estimated)
Ages18 Years and up
SexAll
SponsorPfizer (industry)
Drugs / interventionschemotherapy, radiation
Locations38 sites (Los Angeles, California and 37 other locations)
Trial IDNCT04557449 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced solid tumors, particularly those with hormone receptor-positive breast cancer or metastatic castration-resistant prostate cancer.

Not a fit: Patients with tumors that do not express CDK4 or CCND1 amplification or those with biochemical recurrence only may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that are resistant to current therapies.

How similar studies have performed: Other studies using CDK4 inhibitors have shown promise in treating similar conditions, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Los Angeles, California and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Liposarcoma, Prostate Cancer, Breast Neoplasms, Adenocarcinoma of Lung, CDK4 inhibitor, Breast cancer, enzalutamide, fulvestrant

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.