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2-((S)-4-((S)-7-(3-Amino-2-Fluoro-5-Methyl-6-(Trifluoromethyl)Phenyl)-2-(((2R,7As)-2-Fluorotetrahydro-1H-Pyrrolizin-7A(5H)-Yl)Methoxy)-7,8-Dihydro-5H-Pyrano(4,3-D)Pyrimidin-4-Yl)-1-(2-Fluoroacryloyl)Piperazin-2-Yl)Acetonitrile

This article discusses ongoing clinical trials investigating the use of D3S-001, a new drug designed to target advanced solid tumors with a specific genetic mutation called KRAS p.G12C. The trials aim to assess the safety, tolerability, and potential effectiveness of D3S-001 when used alone or in combination with other cancer treatments. These studies represent an important step in developing targeted therapies for patients with certain types of advanced cancer.

Table of Contents

What is D3S-001?

D3S-001 is a new medication being developed to treat certain types of cancer. Its full chemical name is 2-((S)-4-((S)-7-(3-AMINO-2-FLUORO-5-METHYL-6-(TRIFLUOROMETHYL)PHENYL)-2-(((2R,7AS)-2-FLUOROTETRAHYDRO-1H-PYRROLIZIN-7A(5H)-YL)METHOXY)-7,8-DIHYDRO-5H-PYRANO(4,3-D)PYRIMIDIN-4-YL)-1-(2-FLUOROACRYLOYL)PIPERAZIN-2-YL)ACETONITRILE. It’s currently being studied in a clinical trial to see how safe and effective it is for treating advanced solid tumors.[1]

What condition does D3S-001 target?

D3S-001 is designed to treat advanced solid tumors with a specific genetic mutation called KRAS p.G12C. Solid tumors are abnormal masses of tissue that don’t contain cysts or liquid areas. They can occur in many parts of the body, such as the lungs, breast, colon, or prostate. The term “advanced” means that the cancer has spread from where it started to other parts of the body.[1]

The KRAS p.G12C mutation is a specific change in the DNA of cancer cells. This mutation affects how the cell grows and divides, often making the cancer more aggressive and harder to treat with standard therapies. By targeting this specific mutation, D3S-001 aims to provide a more personalized treatment approach.[1]

How does D3S-001 work?

D3S-001 is classified as a KRAS p.G12C mutant protein inhibitor. This means it’s designed to block the activity of the abnormal KRAS protein produced by cells with the G12C mutation. By doing so, it may help to slow down or stop the growth of cancer cells with this specific mutation.[1]

Current Clinical Trial

D3S-001 is currently being studied in a clinical trial. This trial is a Phase 1/2, open-label, dose-escalation, and dose-expansion study. Here’s what these terms mean:

  • Phase 1/2: This is an early stage of testing in humans. The main goals are to determine if the drug is safe and to find the right dose.
  • Open-label: Both the researchers and the participants know which treatment is being given.
  • Dose-escalation: The study starts with a low dose of the drug and gradually increases it to find the best dose.
  • Dose-expansion: Once a safe dose is found, more participants are given this dose to further study its effects.

The study is looking at D3S-001 both as a single treatment (monotherapy) and in combination with other anti-cancer medicines.[1]

Who is eligible for the trial?

The trial has specific criteria for who can participate. Some key points include:

  • Participants must have a confirmed advanced solid tumor that is progressing.
  • They must have a documented KRAS p.G12C mutation in their tumor.
  • The tumor must be measurable according to specific criteria.
  • Participants must have good overall health status.
  • There are certain medical conditions or previous treatments that may exclude someone from participating.

It’s important to note that these are just some of the criteria. A healthcare provider would need to do a full assessment to determine if someone is eligible for the trial.[1]

What are the objectives of the trial?

The main goals of this clinical trial are:

  1. To evaluate how safe D3S-001 is and how well patients tolerate it, both when used alone and in combination with other drugs.
  2. To determine the best dose of D3S-001 for future studies.
  3. To study how the drug moves through and is processed by the body (this is called pharmacokinetics).
  4. To see how effective D3S-001 is at treating tumors with the KRAS p.G12C mutation.

The researchers will be looking at things like side effects, how the drug affects tumor size, and how long the drug’s effects last.[1]

How is safety monitored during the trial?

Patient safety is a top priority in clinical trials. During this study, researchers will closely monitor:

  • Any side effects that occur during treatment
  • Changes in vital signs (like blood pressure and heart rate)
  • Results of physical examinations
  • ECG readings (which show the electrical activity of the heart)
  • Results of various laboratory tests

If any serious side effects occur, the researchers may need to adjust the dose or stop treatment.[1]

Potential Benefits of D3S-001

While it’s important to remember that D3S-001 is still in the early stages of testing, it has the potential to offer several benefits:

  • It targets a specific genetic mutation (KRAS p.G12C) that is known to drive certain types of cancer, potentially offering a more precise treatment approach.
  • It may provide a new treatment option for patients whose cancer has not responded to or has stopped responding to other treatments.
  • By studying D3S-001 both alone and in combination with other drugs, researchers hope to find the most effective way to use it.

However, as with any experimental treatment, it’s crucial to understand that the full benefits and risks of D3S-001 are not yet known. That’s why clinical trials like this one are so important – they help researchers gather the information needed to determine if a new drug is safe and effective.[1]

Aspect Details
Drug Name D3S-001 (2-((S)-4-((S)-7-(3-Amino-2-Fluoro-5-Methyl-6-(Trifluoromethyl)Phenyl)-2-(((2R,7As)-2-Fluorotetrahydro-1H-Pyrrolizin-7A(5H)-Yl)Methoxy)-7,8-Dihydro-5H-Pyrano(4,3-D)Pyrimidin-4-Yl)-1-(2-Fluoroacryloyl)Piperazin-2-Yl)Acetonitrile)
Trial Phase Phase 1/2
Target Condition Advanced Solid Tumors with KRAS p.G12C Mutation
Main Objectives Evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy
Administration Oral capsule
Key Endpoints Treatment-emergent adverse events, maximum tolerated dose, tumor response (RECIST v1.1)
Eligibility Adults with confirmed KRAS p.G12C mutant solid tumors, measurable disease, ECOG 0-1
Study Design Open-label, dose-escalation, and dose-expansion

FAQ

  • What is D3S-001? D3S-001 is an investigational drug that targets a specific genetic mutation called KRAS p.G12C in advanced solid tumors. It is being studied as a potential treatment option for patients with this particular mutation.
  • What is the main goal of the clinical trials involving D3S-001? The main goal is to evaluate the safety and tolerability of D3S-001 when used alone or in combination with other cancer treatments in adult patients with advanced solid tumors that have the KRAS p.G12C mutation.
  • Who can participate in these clinical trials? Participants must have a confirmed advanced solid tumor that is progressing, a documented KRAS p.G12C mutation, measurable disease, and meet specific health criteria. They should also have an ECOG performance status of 0 or 1 and adequate organ function.
  • How is D3S-001 administered in the trials? D3S-001 is administered orally in the form of capsules. The trials will study different doses and evaluate how food might affect the drug's absorption and effectiveness.
  • What are some of the key outcomes being measured in these trials? The trials will measure side effects, changes in vital signs and lab tests, determine the maximum tolerated dose, assess how the body processes the drug, and evaluate tumor response using standard criteria (RECIST v1.1).

Ongoing Clinical Trials on 2-((S)-4-((S)-7-(3-Amino-2-Fluoro-5-Methyl-6-(Trifluoromethyl)Phenyl)-2-(((2R,7As)-2-Fluorotetrahydro-1H-Pyrrolizin-7A(5H)-Yl)Methoxy)-7,8-Dihydro-5H-Pyrano(4,3-D)Pyrimidin-4-Yl)-1-(2-Fluoroacryloyl)Piperazin-2-Yl)Acetonitrile

  • Study on the Safety and Tolerability of D3S-001 Alone or with Drug Combination in Adults with Advanced Solid Tumors with KRAS p.G12C Mutation

    Recruiting

    2 1 1 1
    Investigated drugs:
    France Germany Italy Spain

Glossary

  • KRAS p.G12C mutation: A specific genetic change in the KRAS gene, which is involved in cell growth and division. This mutation is found in some types of cancer and can affect how the cancer responds to treatment.
  • Solid tumor: A mass of abnormal cells that forms in organs or tissues. Unlike liquid tumors (such as leukemias), solid tumors are typically confined to a specific area of the body.
  • Monotherapy: Treatment using a single drug or method, in this case, using D3S-001 alone.
  • Combination therapy: Treatment that uses two or more drugs or methods together, such as D3S-001 with other anti-cancer medicines.
  • ECOG performance status: A scale used to assess how a patient's disease affects their daily living abilities and determine appropriate treatment and prognosis.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug that does not cause unacceptable side effects.
  • Recommended Phase 2 Dose (RP2D): The dose of a drug recommended for further testing in Phase 2 clinical trials, based on results from earlier studies.
  • Pharmacokinetics (PK): The study of how the body processes a drug, including its absorption, distribution, metabolism, and excretion.
  • RECIST v1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standard way to measure how well a cancer patient responds to treatment.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-tolerability-of-d3s-001-alone-or-with-drug-combination-in-adults-with-advanced-solid-tumors-with-kras-p-g12c-mutation/