AMINOLEVULINIC ACID HYDROCHLORIDE for Colorectal carcinoma

Inclusion criteria

• {"criterion_text":"- Signed and dated informed consent after comprehensive information.\n- Male or female ≥18 years of age.\n- 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.\n- 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\n- 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.\n- 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."}

Exclusion criteria

• {"criterion_text":"- 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.\n- Previous allogenic bone marrow transplantation or insufficient bone marrow function.\n- 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.\n- Known hypersensitivity to porphyrins or the active substance 5-ALA HCl.\n- Known diagnosis of acute or chronic types of porphyria.\n- Clinically significant renal or hepatic impairment including severe chronic conditions/co-morbidities.\n- 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).\n- 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.\n- Pregnancy or breastfeeding.\n- Metastatic colorectal cancer (UICC IV).\n- Current diagnosis of any other tumour (malignant or benign).\n- Suffers from Ulcerative Colitis or Crohn’s Disease.\n- Intercurrent severe infection."}

Primary endpoints

• {"endpoint_text":"- Number of Adverse Drug Reactions (ADRs) graded according to CTCAE v5.0.\n- Number of discontinuations due to ADRs.","definition_or_measurement_approach":"- Graded according to CTCAE v5.0; count of ADRs.\n- Count of study discontinuations due to ADRs."}

Secondary endpoints

• {"endpoint_text":"- Change of CP I / III levels in CRC patient urine samples taken before PD L 506 administration to CP I / III levels in CRC patient urine samples collected 5 ± 1.0 hours after PD L 506 administration at the same day, at Visit 1 (before NAT, for NAT patients only) and Visit 2 (before tumour resection) and Visits 3, 4 and 6 (after NAT / tumour removal).\n- Change of CP I / III levels in CRC patient urine samples collected 5 ± 1.0 hours after PD L 506 administration before NAT / tumour removal (Visit 1 for NAT patients and Visit 2 for other patients) to after NAT / tumour removal (Visits 3, 4 and 6).\n- Change of CP I / III levels in healthy subject urine samples taken before PD L 506 administration to CP I / III levels in healthy subject urine samples collected 5 ± 1.0 hours after PD L 506 administration at the same day (Visit 2).","definition_or_measurement_approach":"- Comparison of CP I/III concentrations in urine pre-dose and 5 ± 1.0 hours post-dose at specified visits for CRC patients (paired measurements across visits as specified).\n- Comparison of CP I/III concentrations in urine samples 5 ± 1.0 hours post-dose before NAT/tumour removal vs after NAT/tumour removal at specified visits.\n- Comparison of CP I/III concentrations in urine pre-dose and 5 ± 1.0 hours post-dose in healthy subjects (Visit 2)."}

Germany

Earliest CTIS Part Ii Submission Date

16-08-2024

Latest Decision Or Authorization Date

09-04-2026

Processing Time Days

601

Number Of Sites

2

Number Of Participants

30

Primary sponsor

Full Name

Photonamic GmbH & Co. KG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Third parties

• {"country":"Germany","full_name":"spm²-safety projects & more GmbH","duties_or_roles":"Codes: 13, 8","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Proinnovera GmbH","duties_or_roles":"Codes: 1, 10, 11, 6, 7","organisation_type":"Pharmaceutical company"}