Taking people in GermanyPhase 2
Tests PD L 506 safety and urine porphyrin markers in colorectal cancer
Tests oral PD L 506 in adults with first colorectal cancer and in healthy people.
Key facts
- Who runs it
- Photonamic GmbH & Co. KG
- Where
- Essen and Munich, GermanySee the 3 sites
- Trial code
- Registry title
- 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.
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 30 people, planned
- Started
- 12 Nov 2024
- Expected to end
- 30 Apr 2028
- Type of study
- Interventional
- Record updated
- 18 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed colorectal cancer that has not spread, and for healthy adults without colorectal cancer. It tests the safety of an oral drug, PD L 506.
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- Patients: newly diagnosed colorectal cancer, not metastatic and removable by surgery (below UICC stage IV). Healthy people: no cancer.
- Earlier treatment
- Patients must not have started anti-cancer treatment for colorectal cancer.
- Biomarker or test result
- Patients need a confirmed tissue diagnosis (histopathology). Healthy people need a colonoscopy within the last 5 years that reached the ileocecal valve and showed no cancer.
Main reasons for not taking part
- Metastatic colorectal cancer (UICC IV)
- Any other tumour, malignant or benign
- Ulcerative colitis or Crohn's disease
- Porphyria, or known allergy to porphyrins or 5-ALA HCl
- Pregnancy or breastfeeding
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- 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
- Known diagnosis of acute or chronic types of porphyria
- Pregnancy or breastfeeding
Where in Germany
- KEM I Evang. Kliniken Essen-Mitte gGmbHEssen, GermanyTaking people
- Klinikum der Universitaet Muenchen AöRMunich, GermanyTaking people
- Muenchen Klinik gGmbHMunich, GermanyTaking people
About the trial
What the trial wants to find out
To investigate the safety and tolerability of repeated oral administration of 300 mg PD L 506 in subjects with the first occurrence of CRC (Cohort 1) and of single oral administration of 300 mg PD L 506 in subjects without CRC (Healthy Subjects, Cohort 2).
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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.
- Plain-language title
- Tests PD L 506 safety and urine porphyrin markers in colorectal cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 18 September 2026