In short
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.
At a glance
- 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
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. Its full chemical name is 4-[1-[[6-[[4-(TRIFLUOROMETHYL)PHENYL]METHYL]-6-AZASPIRO[2.5]OCTANE-7-CARBONYL]AMINO]CYCLOPROPYL]BENZOIC ACID. 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. 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. 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.
- 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.
Current research on CR6086
CR6086 is currently being studied in a clinical trial. This trial is designed to:
- Evaluate how safe CR6086 is when combined with balstilimab.
- Determine how effective this combination is in treating the targeted cancers.
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.
- Objective Response Rate (ORR): This looks at how many patients have their tumors shrink significantly.
- Duration of Response (DOR): This measures how long the drug keeps working for patients who respond to it.
- Progression-Free Survival (PFS): This looks at how long patients live without their cancer getting worse.
- Overall Survival (OS): This measures how long patients live overall.
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.
- They must have advanced-stage cancer that can't be surgically removed.
- Patients must have tried at least one previous treatment for their metastatic cancer.
- They need to be in relatively good overall health, with adequate organ function.
There are also several factors that might prevent someone from participating, such as having certain other medical conditions or having received specific treatments recently.
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
- Liver and kidney function
- Digestive system effects, given the drug's focus on GI cancers
- Immune system-related side effects, as the drug affects immune function
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.