#1 Clinical Trials Search in Europe

Pf-07220060 Monohydrate

This article summarizes several clinical trials investigating the use of PF-07220060 Monohydrate, a novel drug, for treating advanced breast cancer. These studies aim to evaluate the safety, efficacy, and optimal dosing of PF-07220060 alone and in combination with other therapies for patients with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. The trials explore various treatment regimens and patient populations to determine the most promising approaches for improving outcomes in this difficult-to-treat cancer type.

Table of Contents

What is PF-07220060?

PF-07220060 MONOHYDRATE is an investigational drug being developed by Pfizer for the treatment of advanced breast cancer and other solid tumors. It is a new type of medication that is taken orally in the form of tablets or film-coated tablets[1].

How does it work?

PF-07220060 is believed to work by inhibiting certain proteins called cyclin-dependent kinases (CDKs), specifically CDK4 and CDK6. These proteins play an important role in regulating cell growth and division. By blocking their activity, PF-07220060 may be able to slow down or stop the growth of cancer cells[2].

What conditions does it treat?

PF-07220060 is primarily being studied for the treatment of:

  • Hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer: This is a type of breast cancer that has spread beyond the breast to other parts of the body and is driven by hormones like estrogen or progesterone[1].
  • Prostate cancer: Specifically, metastatic castration-resistant prostate cancer (mCRPC)[3].
  • Other advanced solid tumors, including:
    • Non-small cell lung cancer (NSCLC)
    • Colorectal cancer (CRC)
    • Liposarcoma
    • Tumors with confirmed CDK4 or CCND1 amplification[4]

Clinical Trials

PF-07220060 is currently being evaluated in several clinical trials:

  1. Study C4391022: A Phase 3 study comparing PF-07220060 plus fulvestrant to investigator’s choice of therapy in patients with HR+/HER2- advanced/metastatic breast cancer who have progressed after prior CDK4/6 inhibitor therapy[1].
  2. Study C4891026: A Phase 1b/2 study investigating the combination of PF-07220060 with vepdegestrant (ARV-471/PF-07850327) in patients with ER+/HER2- advanced or metastatic breast cancer[2].
  3. Study C4391002: A Phase 1b/2 study evaluating PF-07220060 in combination with PF-07104091 plus endocrine therapy in patients with advanced solid tumors, including HR+/HER2- breast cancer[3].
  4. Study C4391001: A Phase 1/2a study assessing PF-07220060 as a single agent and in combination with other therapies in patients with various advanced solid tumors[4].
  5. Study C4391025: A Phase 2 study comparing PF-07220060 plus letrozole to letrozole alone in postmenopausal women with HR+/HER2- breast cancer in the neoadjuvant setting[5].

Potential Benefits

Based on the ongoing clinical trials, PF-07220060 may offer several potential benefits:

  • Improved progression-free survival (PFS) in patients with advanced breast cancer[1]
  • Potential to overcome resistance to prior CDK4/6 inhibitor therapy[1]
  • Combination potential with other targeted therapies and endocrine therapies[2][3]
  • Oral administration, which may be more convenient for patients compared to intravenous treatments[4]
  • Possible efficacy in multiple types of solid tumors[4]

Side Effects and Safety

As PF-07220060 is still in clinical trials, the full safety profile is not yet established. However, some potential side effects and safety considerations based on the ongoing studies include:

  • Changes in blood cell counts (e.g., decreased white blood cells, platelets, or red blood cells)[1]
  • Liver function abnormalities[1]
  • Gastrointestinal effects (e.g., nausea, diarrhea)[4]
  • Fatigue[4]
  • Potential for drug interactions, particularly with medications that affect certain liver enzymes (CYP3A4/5 and UGT2B7)[4]

It’s important to note that the safety and tolerability of PF-07220060 are being closely monitored in all ongoing clinical trials[5].

Future Research

The development of PF-07220060 is ongoing, with several clinical trials in progress. Future research aims to:

  • Determine the most effective dosing regimens and combinations with other therapies[3]
  • Evaluate its efficacy in different types of solid tumors[4]
  • Assess its potential in earlier stages of breast cancer treatment, such as the neoadjuvant setting[5]
  • Further characterize its safety profile and long-term effects[5]
  • Identify biomarkers that may predict which patients are most likely to benefit from the treatment[5]

As research progresses, more information about PF-07220060 and its potential role in cancer treatment will become available. Patients interested in learning more about this investigational drug should speak with their healthcare providers about the latest developments and potential clinical trial opportunities.

Trial Aspect Details
Study Drug PF-07220060 Monohydrate
Cancer Types Primarily HR-positive, HER2-negative advanced or metastatic breast cancer; some trials include other solid tumors
Study Phases Phase 1, Phase 1b, Phase 2, Phase 3
Treatment Combinations PF-07220060 as monotherapy and in combination with fulvestrant, letrozole, enzalutamide, and PF-07104091
Key Objectives Safety, tolerability, efficacy, pharmacokinetics, optimal dosing
Primary Endpoints Progression-free survival, overall survival, objective response rate, Ki-67 expression changes
Secondary Endpoints Duration of response, safety assessments, quality of life measures, biomarker analyses
Patient Populations Adults with advanced solid tumors, focus on breast cancer patients who have progressed on prior therapies
Administration Oral tablets or film-coated tablets, various dosing schedules
Novel Aspects Evaluation in neoadjuvant setting, combination with newer therapies, biomarker-driven assessments

FAQ

  • What is PF-07220060 Monohydrate? PF-07220060 Monohydrate is an investigational drug being studied for the treatment of hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. It is being evaluated both as a single agent and in combination with other therapies.
  • What types of breast cancer are being targeted in these trials? The trials are primarily focused on hormone receptor-positive (HR-positive), HER2-negative advanced or metastatic breast cancer. Some studies also include patients with HR-positive, HER2-positive breast cancer and other solid tumors.
  • What are the main objectives of these clinical trials? The main objectives include assessing the safety, tolerability, and efficacy of PF-07220060 Monohydrate. Researchers are also studying its pharmacokinetics, determining optimal dosing, and evaluating its effectiveness in combination with other treatments like fulvestrant, letrozole, and enzalutamide.
  • How is PF-07220060 Monohydrate administered? PF-07220060 Monohydrate is administered orally, typically in the form of tablets or film-coated tablets. The dosing regimens vary across trials, with some studies using twice-daily dosing.
  • What are some of the key endpoints being measured in these trials? Key endpoints include progression-free survival, overall survival, objective response rate, duration of response, and safety assessments. Some trials also measure changes in tumor biomarkers like Ki-67 expression and circulating tumor DNA (ctDNA) levels.

Ongoing Clinical Trials on Pf-07220060 Monohydrate

  • Study of PF-07220060 and Letrozole for Adults with HR-Positive, HER2-Negative Advanced Breast Cancer Without Prior Treatment

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Czechia Denmark Finland France +10

  • Study of PF-07220060 and Fulvestrant for Adults with Advanced or Metastatic HR-positive, HER2-negative Breast Cancer After Previous Treatment

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Belgium Bulgaria Czechia Denmark Finland France +8

  • Study on the Safety and Effectiveness of Vepdegestrant and PF-07220060 for Adults with ER+/HER2- Advanced or Metastatic Breast Cancer

    Not recruiting

    1 1 1
    Investigated drugs:
    Belgium France Spain

  • Study of PF-07220060 and PF-07104091 with Endocrine Therapy for Patients with Advanced HR-positive HER2-negative Breast Cancer

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Bulgaria Czechia Spain

  • Study on PF-07220060, Letrozole, and Fulvestrant for Patients with Advanced Breast Cancer, Prostate Cancer, and Other Solid Tumors

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Slovakia

  • Study of PF-07220060 and Letrozole for Postmenopausal Women with HR-Positive, HER2-Negative Breast Cancer

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Belgium France Germany Italy Poland Slovakia +2

Glossary

  • HER2-negative: Refers to breast cancer cells that do not have high levels of a protein called human epidermal growth factor receptor 2 (HER2). This affects treatment options and prognosis.
  • Hormone receptor-positive (HR-positive): Describes breast cancer cells that have receptors for either estrogen or progesterone hormones, which can promote cancer growth.
  • Metastatic breast cancer: Breast cancer that has spread beyond the breast and nearby lymph nodes to other parts of the body, such as the bones, lungs, or liver.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • Overall survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive.
  • Objective response rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Duration of response (DoR): The length of time that a tumor continues to respond to treatment without growing or spreading.
  • Pharmacokinetics (PK): The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body.
  • Adverse events (AEs): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Ki-67: A protein in cells associated with tumor cell proliferation and growth. Its presence in higher amounts may indicate more aggressive cancers.
  • Circulating tumor DNA (ctDNA): Fragments of DNA from cancer cells that can be found in the bloodstream, used as a biomarker to monitor cancer progression or treatment response.
  • Neoadjuvant setting: Treatment given before the main treatment, typically before surgery, to shrink a tumor or slow the cancer's growth.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment.
  • Dose-limiting toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dose or require a dose reduction.

References

  1. http://clinicaltrials.eu/trial/study-of-pf-07220060-and-fulvestrant-for-adults-with-advanced-or-metastatic-hr-positive-her2-negative-breast-cancer-after-previous-treatment/
  2. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-vepdegestrant-and-pf-07220060-for-adults-with-er-her2-advanced-or-metastatic-breast-cancer/
  3. http://clinicaltrials.eu/trial/study-of-pf-07220060-and-pf-07104091-with-endocrine-therapy-for-patients-with-advanced-hr-positive-her2-negative-breast-cancer/
  4. http://clinicaltrials.eu/trial/study-on-pf-07220060-letrozole-and-fulvestrant-for-patients-with-advanced-breast-cancer-prostate-cancer-and-other-solid-tumors/
  5. http://clinicaltrials.eu/trial/study-of-pf-07220060-and-letrozole-for-postmenopausal-women-with-hr-positive-her2-negative-breast-cancer/