COLORECTAL CANCER WITH KRAS G12C MUTATION: patient treatment under an international program at Oberig Clinic

This study offers an opportunity to receive free access to innovative targeted therapy for patients with colorectal cancer featuring the KRAS G12C mutation.

Who is this study for? Who can participate?

This clinical trial targets patients who have been diagnosed with locally advanced unresectable or metastatic colorectal cancer (mCRC).

• Important: The study includes patients who have not previously received systemic therapy for metastatic colorectal cancer (this will be their first line of therapy).

• The testing for the presence of the KRAS G12C mutation in patients with colorectal cancer is performed at the clinic FREE OF CHARGE for the patient.

  What is the study design? (KANDLELIT-012)

This is a randomized, open-label, multicenter Phase III clinical trial.

• Randomized: Patients are randomly assigned to one of two treatment groups (like flipping a coin), which ensures an unbiased assessment of the new drug's efficacy.

• Open-Label: Both the patients and the physicians will know exactly which treatment regimen the participant is receiving.

• Treatment Groups (Arm A and Arm B):

  • Arm A (Investigational): The new targeted agent MK-1084 in combination with FOLFOX chemotherapy and the biological agent Cetuximab.

  • Arm B (Control / Standard): Standard FOLFOX chemotherapy with or without the addition of the biological agent Bevacizumab.

• Study Goal: To compare the safety and efficacy of the new combination with MK-1084 (Arm A) versus standard treatment (Arm B).

Basic Study Information

Inclusion / Exclusion Criteria

To ensure safety and obtain reliable results, participants must meet strict medical requirements:

✅ Inclusion

• Diagnosis of metastatic colorectal cancer (mCRC), Stage IV.

• Confirmed KRAS G12C mutation.

• No prior systemic therapy for mCRC.

• Satisfactory general health status (ECOG Performance Status 0–1).

• Availability of an archival or new tumor biopsy for analysis.

❌ Exclusion

• Any previous therapy targeting KRAS or EGFR.

• Radiation therapy completed less than 2 weeks prior to study start.

• History of organ transplantation.

• Hypersensitivity (allergy) to any component of the study drugs.

The program includes the following examinations:

• Tumor biopsy

• Laboratory tests: CEA, hormone panel, viral disease screening, general clinical and biochemical analyses, including liver function tests.

• ECG, CT/MRI, PET CT, ophthalmological examination.

Benefits for the Patient

Participation in the study is your chance to receive treatment that could become the next breakthrough in the fight against your disease.

• Access to Innovation: You will gain access to MK-1084 – a new, first-in-class KRAS G12C inhibitor that is not yet available in routine clinical practice.

• Free Treatment and Testing: All costs associated with the study (investigational drugs, chemotherapy, necessary lab tests, CT/MRI, PET, biopsy, ECG, ophthalmological exams) are fully covered.

• High Level of Medical Care: You will be under the constant, close supervision of highly qualified physicians, ensuring the timely detection and management of any side effects.

• Potential for Increased Longevity: Innovative therapy that targets a unique mutation may offer a better response to treatment compared to standard approaches.

What Behavior Must the Patient Adhere To?

Adherence to instructions is critically important for your safety and the success of the study.

• Daily Drug Intake: You will take MK-1084 in tablet form daily at home, according to instructions.

• Keeping a Diary: It is necessary to maintain a detailed diary of drug intake and record any changes in well-being or side effects.

• Regular Visits: You must regularly (approximately every 2 weeks) visit the clinic for the intravenous administration of chemotherapy (FOLFOX) and other drugs (Cetuximab, ± Bevacizumab) and for control examinations.

Practical Aspects and Logistics

• Location of MK-1084 Intake: At home, orally.

• Location of Infusions: At the research center (the clinic).

• Reimbursement of Expenses: All expenses related to participation (including travel costs that may arise for clinic visits) are reimbursed.

Comparison with Standard Treatment

Priorities in Treatment

• Safety and Control: While MK-1084 is a new drug and its full safety profile is still being studied (side effects may include reactions typical of chemotherapy, as well as those specific to targeted therapy, such as gastrointestinal symptoms or photosensitivity), you will be under the constant supervision of a team of experienced oncologists and researchers. Any side effects will be recorded and promptly managed.

• Confidentiality Guaranteed: Your personal medical information is strictly confidential and protected in accordance with international clinical research standards (ICH-GCP). Your data will be used exclusively for scientific purposes.

• Free Innovative Treatment: All costs for innovative therapy, diagnostics, and support are fully covered by the sponsor. You do not pay a single penny.

• Unique Opportunity: Participating in this study gives you a real chance to receive breakthrough treatment that may significantly increase your longevity and quality of life compared to conventional therapy. Do not miss the opportunity to fight the disease with cutting-edge science.

Would you like to learn more and check if you meet the eligibility criteria? Contact us at +38 066-947-23-33 (Tetyana Baganina).