NCT02826837

LEAC-102 for Advanced Colorectal Cancer

A Phase I/IIa Dose-Escalation Study Evaluating the Safety, Tolerability and Efficacy of LEAC-102 in Combination With FOLFOX + Bevacizumab/Cetuximab in Subjects With Advanced Colorectal Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Taiwan Leader Biotech Corp. · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Phase I/IIa Dose-Escalation Study Evaluating the Safety, Tolerability and Efficacy of LEAC-102 in Combination with FOLFOX + Bevacizumab/Cetuximab in Subjects with Advanced Colorectal Cancer

Conditions

• Advanced Colorectal Cancer

Interventions

Type	Name	Description
DRUG	LEAC-102 500mg capsule and FOLFOX + Bevacizumab/Cetuximab	The subjects will be administered FOLFOX + Bevacizumab/Cetuximab by intravenous infusion. Cycles repeat every 2 weeks. Dose and schedule modifications may be made at the treating physician's discretion. A standard 3+3 trial design will be used for LEAC-102 dose escalation cohorts.The dosing of LEAC-102 will be divided into 3 cohorts, the subjects will receive LEAC-102 every day Cohort 1: LEAC-102 500 mg capsule, 3 capsules, three times per day for 24 weeks (oral), Cohort 2: LEAC-102 500 mg capsule, 4 capsules, three times per day for 24 weeks (oral), Cohort 3: LEAC-102 500 mg capsule, 5 capsules, three times per day for 24 weeks (oral)

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2016-07-11
• Last updated: 2021-10-06

Regulatory

• FDA-regulated drug study