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4-[1-[[6-[[4-(Trifluoromethyl)Phenyl]Methyl]-6-Azaspiro[2.5]Octane-7-Carbonyl]Amino]Cyclopropyl]Benzoic Acid

This article discusses a clinical trial investigating the use of CR6086, a drug containing 4-[1-[[6-[[4-(Trifluoromethyl)Phenyl]Methyl]-6-Azaspiro[2.5]Octane-7-Carbonyl]Amino]Cyclopropyl]Benzoic Acid, in combination with balstilimab (AGEN2034) for patients with pretreated metastatic colorectal cancer and other gastrointestinal cancers. The study aims to assess the safety and effectiveness of this combination therapy in patients who have not responded well to previous treatments.

Table of Contents

What is CR6086?

CR6086 is a new drug being studied for the treatment of certain types of cancer, particularly colorectal cancer and other gastrointestinal (GI) cancers[1]. Its full chemical name is 4-[1-[[6-[[4-(TRIFLUOROMETHYL)PHENYL]METHYL]-6-AZASPIRO[2.5]OCTANE-7-CARBONYL]AMINO]CYCLOPROPYL]BENZOIC ACID[1]. This long name describes the drug’s chemical structure, which is important for how it works in the body.

How does CR6086 work?

CR6086 is classified as an EP4 receptor antagonist[1]. This means it blocks a specific receptor in the body called EP4. By doing this, CR6086 may help boost the immune system’s ability to fight cancer cells. It’s being studied in combination with another drug called balstilimab (also known as AGEN2034), which is a type of immunotherapy drug called a PD-1 inhibitor[1]. The combination of these two drugs is thought to potentially enhance the body’s immune response against cancer.

What conditions does CR6086 treat?

CR6086 is currently being studied for the treatment of:

  • Metastatic colorectal cancer (mCRC): This is colon or rectal cancer that has spread to other parts of the body. Specifically, the study is looking at a type called “mismatch-repair-proficient” (pMMR) and “microsatellite stable” (MSS) mCRC[1].
  • Other metastatic gastrointestinal (GI) cancers: This includes cancers of the stomach, esophagus, and other parts of the digestive system that have spread to other areas of the body[1].

Current research on CR6086

CR6086 is currently being studied in a clinical trial. This trial is designed to:

  1. Evaluate how safe CR6086 is when combined with balstilimab[1].
  2. Determine how effective this combination is in treating the targeted cancers[1].

The researchers are looking at several factors to measure the drug’s effectiveness, including:

  • Disease Control Rate (DCR): This measures how many patients have their cancer shrink or stop growing[1].
  • Objective Response Rate (ORR): This looks at how many patients have their tumors shrink significantly[1].
  • Duration of Response (DOR): This measures how long the drug keeps working for patients who respond to it[1].
  • Progression-Free Survival (PFS): This looks at how long patients live without their cancer getting worse[1].
  • Overall Survival (OS): This measures how long patients live overall[1].

Who can participate in CR6086 trials?

The current trial for CR6086 has specific criteria for who can participate. Some key points include:

  • Patients must be 18 years or older[1].
  • They must have advanced-stage cancer that can’t be surgically removed[1].
  • Patients must have tried at least one previous treatment for their metastatic cancer[1].
  • They need to be in relatively good overall health, with adequate organ function[1].

There are also several factors that might prevent someone from participating, such as having certain other medical conditions or having received specific treatments recently[1].

Potential side effects

As CR6086 is still in the research phase, all of its potential side effects are not yet known. The current study is closely monitoring patients for any adverse effects. Some areas of particular interest include:

  • Effects on blood cell counts[1]
  • Liver and kidney function[1]
  • Digestive system effects, given the drug’s focus on GI cancers[1]
  • Immune system-related side effects, as the drug affects immune function[1]

It’s important to note that all medical treatments can have side effects, and the benefits and risks should be carefully considered with a healthcare provider.

Aspect Details
Study Type Phase Ib/IIa, open-label, single-arm clinical trial
Main Drug CR6086 (containing 4-[1-[[6-[[4-(Trifluoromethyl)Phenyl]Methyl]-6-Azaspiro[2.5]Octane-7-Carbonyl]Amino]Cyclopropyl]Benzoic Acid)
Combination Drug Balstilimab (AGEN2034), a PD-1 inhibitor
Target Conditions Pretreated metastatic colorectal cancer and other metastatic GI cancers
Primary Objectives Evaluate safety, tolerability, and preliminary efficacy (Disease Control Rate)
Secondary Objectives Assess Objective Response Rate, Duration of Response, Progression-Free Survival, and Overall Survival
Key Inclusion Criteria Age ≥18, advanced unresectable GI cancers, failed prior chemotherapy, measurable disease
Key Exclusion Criteria Recent other cancers, severe infections, autoimmune diseases, brain metastases, pregnancy
Study Duration 24 weeks of treatment, with longer follow-up for some outcomes

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to evaluate the safety and effectiveness of combining CR6086 with balstilimab in treating patients with pretreated metastatic colorectal cancer and other gastrointestinal cancers that haven't responded well to previous treatments.
  • Who can participate in this clinical trial? Participants must be at least 18 years old, have advanced-stage unresectable adenocarcinoma of the stomach, colorectal, or other GI cancers, and have failed at least one prior line of chemotherapy for metastatic disease. They must also meet specific health criteria and be willing to comply with the study requirements.
  • What are the main outcomes being measured in this trial? The main outcomes being measured include the safety and tolerability of the drug combination, as well as its effectiveness in controlling the disease. This is assessed through measures such as Disease Control Rate (DCR), Objective Response Rate (ORR), and Progression-Free Survival (PFS).
  • How long does the trial last for each participant? The trial assesses patients when they have completed 24 weeks of treatment, unless they discontinued earlier. However, some measurements, like overall survival, may continue to be tracked beyond this period.
  • Are there any specific exclusion criteria for this trial? Yes, there are several exclusion criteria. These include having certain other medical conditions, recent major surgeries, active infections, autoimmune diseases, or a history of certain cancers. Pregnant or breastfeeding women are also excluded, as are those who have recently participated in other clinical trials.

Ongoing Clinical Trials on 4-[1-[[6-[[4-(Trifluoromethyl)Phenyl]Methyl]-6-Azaspiro[2.5]Octane-7-Carbonyl]Amino]Cyclopropyl]Benzoic Acid

  • Study of Pre-Operative Treatments with Sotorasib and Drug Combination for Patients with Resectable Colorectal Cancer

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on the Safety and Efficacy of CR6086 and Balstilimab for Patients with Pretreated Metastatic Colorectal and Other GI Cancers

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

Glossary

  • Metastatic: Cancer that has spread from its original site to other parts of the body.
  • Colorectal Cancer: Cancer that starts in the colon or rectum, parts of the large intestine.
  • Gastrointestinal (GI) Cancer: Cancers that affect the digestive system and its organs.
  • CR6086: The investigational drug being studied, containing 4-[1-[[6-[[4-(Trifluoromethyl)Phenyl]Methyl]-6-Azaspiro[2.5]Octane-7-Carbonyl]Amino]Cyclopropyl]Benzoic Acid.
  • Balstilimab (AGEN2034): A type of immunotherapy drug that works by blocking a protein called PD-1, potentially helping the immune system fight cancer cells.
  • Disease Control Rate (DCR): The percentage of patients whose cancer shrinks or remains stable in response to treatment.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease without it getting worse.
  • Adverse Events: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • ECOG Performance Status: A scale used to assess how a patient's disease is progressing and how it affects daily living abilities.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-efficacy-of-cr6086-and-balstilimab-for-patients-with-pretreated-metastatic-colorectal-and-other-gi-cancers/