Preoperative Radiotherapy and E7046 in Rectum Cancer
Status:
Completed
Trial end date:
2021-09-30
Target enrollment:
Participant gender:
Summary
This is a multicenter, open-label, Phase 1b study in participants with locally advanced
rectum cancer where primary resection without chemoradiotherapy is unlikely to achieve clear
margins as defined by magnetic resonance imaging (MRI). It is conducted to assess the safety,
to assess the tolerability, and to determine the recommended Phase 2 dose (RP2D) of E7046 in
combination with pre-operative chemoradiotherapy. The study will also assess the efficacy of
the combination in the expansion part at RP2D.