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[(1R,3S)-3-[3-[[5-(Methoxymethyl)-2-Methylpyrazole-3-Carbonyl]Amino]-1H-Pyrazol-5-Yl]Cyclopentyl]N-Propan-2-Ylcarbamate Monohydrate

This article discusses clinical trials investigating the use of [(1R,3S)-3-[3-[[5-(Methoxymethyl)-2-Methylpyrazole-3-Carbonyl]Amino]-1H-Pyrazol-5-Yl]Cyclopentyl]N-Propan-2-Ylcarbamate Monohydrate, also known as PF-07104091, for treating various advanced cancers. The trials aim to evaluate the safety, effectiveness, and proper dosing of this drug alone and in combination with other cancer treatments. The studies focus on patients with breast cancer, ovarian cancer, and lung cancer, exploring how well the drug works and what side effects it may cause.

Table of Contents

What is PF-07104091?

PF-07104091 is a new investigational drug being developed by Pfizer for the treatment of various advanced cancers[1]. Its chemical name is [(1R,3S)-3-[3-[[5-(METHOXYMETHYL)-2-METHYLPYRAZOLE-3-CARBONYL]AMINO]-1H-PYRAZOL-5-YL]CYCLOPENTYL]N-PROPAN-2-YLCARBAMATE MONOHYDRATE[2]. This medication is currently in clinical trials and is not yet approved for general use.

How does PF-07104091 work?

While the exact mechanism of action is not fully disclosed in the available information, PF-07104091 is being studied as a targeted therapy for cancer. Targeted therapies are designed to interfere with specific molecules involved in cancer growth and progression[1].

What types of cancer is PF-07104091 being studied for?

PF-07104091 is being investigated for several types of advanced or metastatic cancers, including:

  • Breast cancer: Specifically, hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer[1]
  • Ovarian cancer: Advanced platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer[2]
  • Lung cancer: Both small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC)[2]
  • Triple-negative breast cancer (TNBC): Locally recurrent, advanced, or metastatic TNBC[2]

Current Clinical Trials

PF-07104091 is currently being studied in two main clinical trials:

  1. A Phase 1b/2 study (C4391002) evaluating PF-07104091 in combination with another drug (PF-07220060) and endocrine therapy for patients with advanced HR-positive, HER2-negative breast cancer[1].
  2. A Phase 1/2a study (C4161001) investigating PF-07104091 as a single agent and in combination with other therapies for various advanced solid tumors[2].

These trials aim to assess the safety, tolerability, pharmacokinetics (how the drug moves through the body), and anti-tumor activity of PF-07104091[1][2].

Potential Benefits and Side Effects

As PF-07104091 is still in clinical trials, its full benefits and side effects are not yet known. The ongoing studies are designed to evaluate:

  • Anti-tumor activity: Researchers are looking at how well the drug works to shrink or slow the growth of tumors[1][2].
  • Safety and tolerability: The studies are closely monitoring for any adverse events (side effects) that may occur during treatment[1][2].

Common side effects of cancer treatments may include fatigue, nausea, and changes in blood cell counts. However, the specific side effects of PF-07104091 will be better understood as the clinical trials progress.

Who might be eligible for PF-07104091 treatment?

Currently, PF-07104091 is only available through clinical trials. Eligibility criteria for these trials typically include:

  • Adults aged 18 years or older[2]
  • Diagnosis of one of the specific cancer types being studied (e.g., HR-positive HER2-negative breast cancer, ovarian cancer, lung cancer)[1][2]
  • Advanced or metastatic disease that has not responded to standard treatments[2]
  • Adequate organ function and overall health status[2]

It’s important to note that there are also specific exclusion criteria, such as certain medical conditions or prior treatments, that might make a person ineligible for the trial[2].

Future Prospects

PF-07104091 represents a potential new treatment option for patients with advanced cancers. If the clinical trials show promising results in terms of efficacy and safety, it could lead to further studies and potentially FDA approval for use in specific cancer types.

As research continues, we may gain a better understanding of how PF-07104091 works and which patients are most likely to benefit from it. This could potentially open up new treatment possibilities for patients with hard-to-treat cancers[1][2].

Aspect Details
Drug Name [(1R,3S)-3-[3-[[5-(Methoxymethyl)-2-Methylpyrazole-3-Carbonyl]Amino]-1H-Pyrazol-5-Yl]Cyclopentyl]N-Propan-2-Ylcarbamate Monohydrate (PF-07104091)
Cancer Types Studied HR-positive HER2-negative breast cancer, Triple-negative breast cancer, Ovarian cancer, Small cell lung cancer, Non-small cell lung cancer
Study Phases Phase 1/2a and Phase 1b/2
Administration Oral tablet
Treatment Approaches Single agent and in combination with endocrine therapy (fulvestrant or letrozole) and/or palbociclib
Primary Objectives Assess safety, tolerability, determine proper dosing, evaluate effectiveness
Secondary Objectives Evaluate pharmacokinetics, assess anti-tumor activity, study food effects on drug absorption
Key Eligibility Criteria Adults (≥18 years), specific cancer diagnoses, adequate organ function
Main Safety Assessments Adverse events, laboratory abnormalities, vital signs, ECG changes
Efficacy Measurements Objective response rate (ORR), duration of response (DoR), progression-free survival (PFS)

FAQ

  • What types of cancer are being studied in these clinical trials? The clinical trials are studying the drug's effects on several types of advanced cancer, including HR-positive HER2-negative breast cancer, triple-negative breast cancer (TNBC), ovarian cancer, small cell lung cancer (SCLC), and non-small cell lung cancer (NSCLC).
  • How is the drug being administered in these trials? The drug PF-07104091 is being administered orally in tablet form. It is being tested both as a single agent and in combination with other cancer treatments such as endocrine therapy (fulvestrant or letrozole) and palbociclib.
  • What are the main goals of these clinical trials? The main goals of these trials are to assess the safety and tolerability of PF-07104091, determine the proper dosing, evaluate its effectiveness in treating various cancers, and study how the body processes the drug (pharmacokinetics).
  • Who is eligible to participate in these clinical trials? Eligibility varies, but generally includes adults (18 years or older) with specific types of advanced cancers who meet certain health criteria. Participants must have adequate organ function and be willing to comply with all study procedures. Some trials have specific requirements regarding prior treatments.
  • What are some of the potential side effects being monitored in these trials? The trials are monitoring for various side effects, including but not limited to changes in blood cell counts, liver function, kidney function, and heart rhythm (QT interval). They are also watching for any serious adverse events related to the treatment.

Ongoing Clinical Trials on [(1R,3S)-3-[3-[[5-(Methoxymethyl)-2-Methylpyrazole-3-Carbonyl]Amino]-1H-Pyrazol-5-Yl]Cyclopentyl]N-Propan-2-Ylcarbamate Monohydrate

  • Study on the Safety and Effectiveness of PF-07104091 Alone or with Fulvestrant, Letrozole, and Palbociclib for Patients with Advanced Breast, Ovarian, or Lung Cancer

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria

  • 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

Glossary

  • HR-positive HER2-negative: A type of breast cancer that has receptors for hormones (estrogen or progesterone) but does not have too much of a protein called HER2. This affects how the cancer grows and what treatments may work best.
  • Triple-negative breast cancer (TNBC): A type of breast cancer that doesn't have receptors for estrogen, progesterone, or HER2 protein. It can be more aggressive and have fewer treatment options than other types of breast cancer.
  • Small cell lung cancer (SCLC): A fast-growing type of lung cancer that usually starts in the bronchi (large airways) in the center of the chest.
  • Non-small cell lung cancer (NSCLC): The most common type of lung cancer, which grows and spreads more slowly than small cell lung cancer.
  • Endocrine therapy: Treatment that adds, blocks, or removes hormones to slow or stop the growth of certain cancers, such as breast cancer.
  • Pharmacokinetics: The study of how the body processes a drug, including how it's absorbed, distributed, metabolized, and eliminated.
  • Dose-limiting toxicity (DLT): Side effects of a treatment that are severe enough to prevent increasing the dose or continuing the treatment.
  • Maximum tolerated dose (MTD): The highest dose of a drug that can be given without causing unacceptable side effects.
  • Recommended dose for expansion (RDE): The dose of a drug chosen for further study in larger groups of patients, based on safety and effectiveness findings from earlier studies.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment based on changes in tumor size.

References

  1. http://clinicaltrials.eu/trial/study-of-pf-07220060-and-pf-07104091-with-endocrine-therapy-for-patients-with-advanced-hr-positive-her2-negative-breast-cancer/
  2. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-pf-07104091-alone-or-with-fulvestrant-letrozole-and-palbociclib-for-patients-with-advanced-breast-ovarian-or-lung-cancer/