In short
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.
At a glance
- 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)
What is PF-07104091?
PF-07104091 is a new investigational drug being developed by Pfizer for the treatment of various advanced cancers. 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. 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.
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
- Ovarian cancer: Advanced platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
- Lung cancer: Both small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC)
- Triple-negative breast cancer (TNBC): Locally recurrent, advanced, or metastatic TNBC
Current Clinical Trials
PF-07104091 is currently being studied in two main clinical trials:
- 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.
- A Phase 1/2a study (C4161001) investigating PF-07104091 as a single agent and in combination with other therapies for various advanced solid tumors.
These trials aim to assess the safety, tolerability, pharmacokinetics (how the drug moves through the body), and anti-tumor activity of PF-07104091.
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.
- Safety and tolerability: The studies are closely monitoring for any adverse events (side effects) that may occur during treatment.
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
- Diagnosis of one of the specific cancer types being studied (e.g., HR-positive HER2-negative breast cancer, ovarian cancer, lung cancer)
- Advanced or metastatic disease that has not responded to standard treatments
- Adequate organ function and overall health status
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.
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.