NCT05093907

A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Capecitabine in Patients with Metastatic Colorectal Cancer

An Open-label, Single Center, Phase I/II Clinical Trial to Assess the Maximum Tolerated Dose, Safety and Efficacy of BEY1107 in Combination with Capecitabine in Patients with Metastatic Colorectal Cancer Refractory or Intolerant to Standard of Care

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: BeyondBio Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2 study to evaluate the maximum tolerated dose, safety and efficacy of BEY1107 in combination with capecitabine in patients with metastatic colorectal cancer refractory or intolerant to standard of care (SoC).

Detailed description

In Phase 1, patients who experienced treatment failure of colorectal cancer with the second-line or beyond standard chemotherapy will be enrolled at each dose level of BEY1107 in combination with Capecitabine. Phase 2 will be conducted after RP2D is determined on the Phase 1 results.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	BEY1107	Administer once daily, PO, 3-week continuous dose.
COMBINATION_PRODUCT	Capecitabine	Administer twice daily, PO, 2-week continuous dose, followed by 1-week rest period.

Timeline

• Start date: 2021-08-31
• Primary completion: 2026-11-30
• Completion: 2026-12-31
• First posted: 2021-10-26
• Last updated: 2025-03-10

Locations

1 site across 1 country: South Korea