Phase 2 Colorectal Cancer Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who have given their signed agreement to take part in the trial.
- People who are 18 years of age or older at the time of signing consent.
- People who have a confirmed diagnosis of colorectal cancer (adenocarcinoma) that cannot be surgically removed and/or has spread to other parts of the body, with known results for RAS, BRAF, and MSI tumour markers.
- People who agree to take part in an additional research program that runs alongside the trial.
- People who have not previously received any treatment for their cancer in a palliative (non-curative) setting — meaning this would be their first treatment of this kind.
- People who are largely able to care for themselves and carry out light activities (a standard fitness measure doctors use, scored 0 or 1 out of 5).
- People whose blood counts, liver function, and kidney function meet specific healthy ranges as assessed by blood tests (confirm exact values with the trial site).
- People whose blood calcium and phosphate levels are within the normal range.
- People who are willing and able to follow the trial schedule, including attending appointments and completing all required visits.
- People of childbearing potential, or those with partners of childbearing potential, who agree to use highly effective contraception during treatment and for a specified period afterwards, and female participants who have a negative pregnancy test within 7 days before starting treatment.
Who may not be able to join:
- People whose colorectal cancer is considered curable.
- People who have previously been treated with a type of drug that targets FGFR (a specific protein involved in cancer growth).
- People who have another active cancer, other than certain treated skin cancers or treated cervical pre-cancers, unless they received curative treatment and have been cancer-free for at least 5 years (the trial sponsor reviews these cases individually).
- People who have cancer that has spread to the brain or the lining of the brain/spinal cord that is either untreated or currently causing symptoms.
- People with a history of, or current, significant disorders affecting calcium and phosphate balance in the body unrelated to their tumour, or abnormal mineral deposits in soft tissues or organs.
- People who are currently receiving other cancer treatments such as immunotherapy, chemotherapy, or hormone-based cancer therapy not described in this trial (palliative radiotherapy for symptom relief only may be acceptable — confirm with trial site).
- People with significant liver scarring (cirrhosis) of a certain severity, or cirrhosis of any level combined with a history of brain complications from liver disease or significant fluid build-up in the abdomen.
- People who have a known allergy or sensitivity to any of the trial medications.
- People who have moderate or severe nerve damage causing weakness, numbness, or pain (grade 2 or higher neuropathy).
- People who have taken the herbal supplement St. John's Wort within 6 weeks before starting the trial.
- People with existing or ongoing eye conditions, including but not limited to certain retinal disorders, macular degeneration, diabetic eye disease, or previous retinal detachment.
- People who have had other serious illnesses or medical conditions within the 12 months before the trial starts.
- People with an active, uncontrolled infection.
- People with a condition where the blood's clotting system is abnormally activated throughout the body (disseminated intravascular coagulation).
- People with any other serious health condition that, in the doctor's judgement, would put them at high risk or reduce the likelihood of the trial being effective for them.
- People who have taken part in another interventional clinical trial within 28 days before enrolling, or who are currently in another interventional trial at the same time.
- People who have had major surgery within 4 weeks, extended-field radiotherapy within 4 weeks, limited-field radiotherapy within 2 weeks, or any experimental drug treatment within 4 weeks before starting the trial.
- People who are pregnant, breastfeeding, or planning to become pregnant within 6 months after finishing treatment.
- People who have previously been treated with certain immunotherapy drugs that target PD-1, PD-L1, or CTLA-4 pathways.
- People who have an active autoimmune disease or a history of autoimmune disease (such as autoimmune hepatitis, certain lung, eye, bowel, or kidney conditions, or others — confirm specifics with the trial site). Some conditions such as childhood asthma that has fully resolved may still be eligible (confirm with trial site).
- People who have a weakened immune system, or who are taking steroid medication above a certain dose, or other immune-suppressing medications within 2 weeks before starting treatment.
- People with uncontrolled HIV infection, or ongoing hepatitis B or C infection.
- People who have received a solid organ transplant.
- People with a history of a lung condition called interstitial lung disease.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Salah Al-Batran, Prof. Dr., Institut für Klinische Krebsforschung IKF GmbH
Phone: 0049 69 7601
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Overall Response Rate (ORR) according to RECIST v1.1
Can't join this trial?
Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.