Drug intelligence / Profile preview

PEP503 + 5-fluorouracil + capecitabine

Development stage
Unknown
Lead developer
Nanobiotix
Modality
Nanoparticles → Drug Delivery Systems, Small Molecules
Administration
Intratumoral (PEP503), Intravenous (5-fluorouracil), Oral (capecitabine)
01

Overview

PEP503 + 5-fluorouracil + capecitabine is a combination regimen under clinical investigation for locally advanced or unresectable rectal cancer. PEP503, also known as NBTXR3, is a biocompatible nanoparticle radioenhancer composed of hafnium oxide, administered by a single intratumoral injection and designed to enhance the effects of ionizing radiation in cancer therapy by increasing local radiation dose deposition within tumor cells. When activated by radiotherapy, NBTXR3 increases cancer cell death and improves tumor control without increasing toxicity to normal tissue. In combination trials, it is used with standard fluoropyrimidine-based chemotherapy: either 5-fluorouracil (an antimetabolite small molecule that inhibits thymidylate synthase, blocking DNA synthesis) or capecitabine (an oral prodrug of 5-fluorouracil). This regimen is being investigated for its cumulative antitumor effect in patients with locally advanced or unresectable rectal adenocarcinoma, with evidence of strong response rates and safety in early-phase clinical trials[1][2][4].

Brand names
NBTXR3NBTXR-3NBTXR 3
Other names
PEP503PEP-503PEP 503
02

Targets

TS (Thymidylate synthase)

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