A pilot study of the safety and tolerability of oral administration of PD L 506 and the subsequent diagnostic value of porphyrin concentration (coproporphyrin I / III, CP I / III) in urine in patients with the first occurrence of colorectal cancer and in healthy subjects.

Prior treatment

• Previous allogenic bone marrow transplantation or insufficient bone marrow function.
• Any current diseases with poor prognosis, e.g., severe coronary heart disease, heart failure (NYHA III/IV), severe and poorly controlled diabetes, immune deficiency, residual deficits after stroke, severe mental retardation or other serious concomitant systemic disorders incompatible with the clinical trial (at the discretion of the investigator).
• Simultaneous participation in another clinical trial or participation in another clinical trial in the 30 days directly preceding treatment or within 5 plasma half-life’s of the preceding trial drug, whatever is longer.

Other illness

• Any psychological, cognitive, familial, sociological, or geographical condition that, in the investigator’s opinion, compromises the patient’s ability to understand the patient information, to give informed consent or to comply with the clinical trial protocol.
• Known hypersensitivity to porphyrins or the active substance 5-ALA HCl.
• Clinically significant renal or hepatic impairment including severe chronic conditions/co-morbidities.
• Metastatic colorectal cancer (UICC IV).
• Current diagnosis of any other tumour (malignant or benign).
• Suffers from Ulcerative Colitis or Crohn’s Disease.
• Intercurrent severe infection.

Lab values

• Subject is not willing to give or sign the informed consent and/or not able to comply with scheduled visits, treatment plan, laboratory tests, and other clinical trial procedures.

Other

• Known diagnosis of acute or chronic types of porphyria.
• Pregnancy or breastfeeding.

• Signed and dated informed consent after comprehensive information.
• Male or female ≥18 years of age.
• CRC patients (cohort 1 only) with newly diagnosed, non-metastatic, resectable colorectal cancer (< UICC IV) must meet the following criteria: Confirmed histopathological diagnosis and anti-cancer therapy for CRC not started.
• Healthy subject (cohort 2 only) meeting the following criteria: Has undergone colonoscopy that extended to the ileocecal valve and was negative for malignancy within 5 years before screening visit
• Willingness of women of childbearing/ reproductive potential and male subjects to use highly effective contraception (Pearl index <1) consistently and correctly for the duration of the clinical trial period through the last follow-up visit required by the protocol.
• Willingness of pre-menopausal female subjects who are of childbearing potential to obtain a negative serum pregnancy test max. 72 h prior to first application of PD L 506 and during the conduct of the clinical trial as appropriate.