NCT03152370

Preoperative Radiotherapy and E7046 in Rectum Cancer

An Open-Label Multicenter Phase 1b Study of E7046 in Combination With Radiotherapy/Chemoradiotherapy (RT/CRT) in Preoperative Treatment of Subjects With Rectum Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Adlai Nortye Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoadjuvant Therapy in Rectal Cancer

Interventions

Type	Name	Description
DRUG	E7046	oral administration
RADIATION	Long Course Chemoradiotherapy (LCRT)	pelvic radiotherapy
RADIATION	Short Course Radiotherapy (SCRT)	pelvic radiotherapy
DRUG	capecitabine	chemotherapy
DRUG	folinic acid/5-FU/oxaliplatin (mFOLFOX-6)	chemotherapy

Timeline

• Start date: 2017-05-17
• Primary completion: 2021-08-31
• Completion: 2021-09-30
• First posted: 2017-05-15
• Last updated: 2021-10-04

Locations

5 sites across 3 countries: United States, Poland, United Kingdom

Regulatory

• FDA-regulated drug study