Safety Study of BMX-001 (Radio-protector) in Patients With Newly Diagnosed Anal Cancer
Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
In this Phase 1/2 study, the investigators will conduct a safety and efficacy study of the
combination of BMX-001 with standard radiation therapy (RT) and concurrent 5-fluorouracil
(5FU)/mitomycin in newly diagnosed Anal Squamous Cell Carcinoma (ASCC) patients. The primary
objectives are: Phase 1 - is to determine the maximum tolerated dose (MTD) of BMX-001 in ASCC
patients receiving RT and concurrent 5FU/mitomycin chemotherapy.2. For phase II part: To
examine the impact of BMX-001 on the overall acute ≥ grade 3 toxicity rate of the normal
tissue including rectum, bladder, and skin in combination with RT and concurrent
5FU/mitomycin in treatment of newly diagnosed ASCC patients