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ENGIC 01 - COLOSOTO: A single-arm phase II study evaluating 5-fluorouracil plus Panitumumab (anti-EGFR) and Sotorasib (KRAS G12C inhibitor) in first-line treatment of patients non-eligible for a doublet/triplet chemotherapy with advanced unresectable KRAS G12C mutated colorectal adenocarcinoma
EU CTIS ID: 2024-514030-20-00
What this study is testing
Progression-free survival of under 5-fluorouracil plus Panitumumab and Sotorasib (KRAS G12C inhibitor) at 8 months in first-line treatment of patients non-eligible for a doublet/triplet chemotherapy with advanced unresectable KRAS G12C mutated colorectal adenocarcinoma.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Provides written informed consent for the study.
- Life expectancy >6 months
- Women of childbearing potential must agree to use contraception during the trial treatment and for at least 6 months after discontinuation of the experimental treatments. Men who have sexual relationship with women of childbearing potential must agree to use contraception during treatment and for at least 3 months after discontinuation of the experimental treatments
- Patient affiliated to a social security scheme for France, or equivalent for other countries
- Histologically proven advanced-stage unresectable locally advanced or metastatic colorectal adenocarcinoma
You likely can't join if
- Uncontrolled intercurrent illness including liver (liver cirrhosis Child Pugh B or C) and lung (one second forced expiratory volume <50%) severe insufficiency
- Patient with interstitial lung disease or pulmonary fibrosis
- Has a known psychiatric or substance abuse disorder that would interfere with the patient’s ability to cooperate with the requirements of the study
- Patient who is under judicial protection and patient who is legally institutionalized or under guardianship or not able to give consent
- Pregnant or breastfeeding woman
- Inability to undergo the medical follow-up of the trial for geographical, social or psychological reasons
See the full eligibility criteria
Who can join
- Age ≥ 18 years
- Provides written informed consent for the study.
- Life expectancy >6 months
- Women of childbearing potential must agree to use contraception during the trial treatment and for at least 6 months after discontinuation of the experimental treatments. Men who have sexual relationship with women of childbearing potential must agree to use contraception during treatment and for at least 3 months after discontinuation of the experimental treatments
- Patient affiliated to a social security scheme for France, or equivalent for other countries
- Histologically proven advanced-stage unresectable locally advanced or metastatic colorectal adenocarcinoma
- Agreement to participate to biological studies (blood samples for ctDNA and send tumour block).
- Patient unfit for doublet/triplet regimen: Frail patients (WHO PS=2),patient between 70 and 75 years old with WHO PS 1 - 2, patient ≥ 75 years old with WHO PS 0-2
- Proven KRAS G12C mutation as locally assessed by means of a IVDR compliant test.
- Measurable lesion according to the Response Evaluation Criteria in Solid Tumours 1.1 (RECIST 1.1).
- No prior treatment for the metastatic disease. Prior adjuvant chemotherapy is allowed.
- Adequate organ function: Hemoglobin > 9 g/dl, Absolute neutrophil count > 1500 /mm3, Platelets > 80 000/mm3, Creatinine clearance rate ≥50 mL/min as calculated using MDRD formula, ALT/AST ≤5×ULN and total bilirubin ≤1.5×ULN.
- Ability to understand and sign written informed consent to participate in the study.
What rules you out
- Uncontrolled intercurrent illness including liver (liver cirrhosis Child Pugh B or C) and lung (one second forced expiratory volume <50%) severe insufficiency
- Patient with interstitial lung disease or pulmonary fibrosis
- Has a known psychiatric or substance abuse disorder that would interfere with the patient’s ability to cooperate with the requirements of the study
- Patient who is under judicial protection and patient who is legally institutionalized or under guardianship or not able to give consent
- Pregnant or breastfeeding woman
- Inability to undergo the medical follow-up of the trial for geographical, social or psychological reasons
- Clinically significant cardiac abnormalities including prior history of any of the following: severe cardiomyopathy, congestive heart failure of New York Heart Association grade ≥3, history of clinically significant (i.e., active) atherosclerotic cardiovascular disease (myocardial infarction, unstable angina, cerebrovascular accident within 6 months prior to the first dose of study treatments)
- Patients with Dihydropyrimidine Dehydrogenase (DPD) enzyme deficiencies (uracilemia ≥ 16 ng/mL)
- Immunotherapy within 3 months before the beginning of the treatment study
- Patient under treatment by strong CYP3A4 inducers
- Other malignancy within 2 years prior to study enrolment, except for localized cancer in situ, basal or squamous cell skin cancer adequately treated
- Less than 4 weeks from major surgeries and not recovered adequately from the procedure and/or any complications from the surgery
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 3 weeks or 5 half-lives (whichever longer) before study entry
- Hypersensitivity to one of the active substances or to one of the excipients of the trial treatments
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.