A Study of PEP503(Radio-enhancer) With Radiotherapy and Chemotherapy for Patients With Rectal Cancer
Status:
Recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
Summary
This phase Ib/II study is a prospective, open-label, single arm, nonrandomized study of
PEP503(radio-enhancer).
There are 2 portions in this study.
- Escalation phase (Part Ib): A 3 + 3 dose escalation study design will be adopted in this
phase to identify the recommended injection volume of PEP503 for intratumor injection.
- Expansion phase (Part II): Following the confirmation of the recommended volume of
intratumor injection, 18 additional patients will be enrolled at the recommended volume
level to evaluate for efficacy.