NCT04751955

A Phase lb/ll, Open Label, Single Arm Study With Olinvacimab and Capecitabine in mCRC Patients (OLCAP)

A Phase lb/ll, Multicenter, Open Label, Single Arm Study to Assess the Safety and Efficacy of the Anti-VEGFR2 Monoclonal Antibody Olinvacimab and the Capecitabine in Patients With mCRC Who Failed Two Prior Chemotherapies

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Korean Cancer Study Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim on this study is to assess the safety and efficacy of the anti-VEGFR2 monoclonal antibody olinvacimab and the capecitabine in patients with metastatic colorectal carcinoma who failed two prior chemotherapies

Detailed description

This is a phase lb/ll, multicenter, open label, single arm study to assess efficacy and safety of the anti-VEGFR2 monoclonal antibody olinvacimab and capecitabine in patients with metastatic colorectal cancer who failed two prior standard chemotherapies. The primary objective of phase lb is to determine maximal tolerated dose (MTD) and recommended phase ll dose (RP2D) of olinvacimab in combination with capecitabine. the primary objective of phase ll is to assess the efficacy of olinvacimab plus capecitabine as a salvage regimen in metastatic colorectal carcinoma.

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Olinvacimab added to Capecitabine	Olinvacimab: IV weekly administration In phase lb, 12mg/kg and 16mg/kg weekly IV will be tested. In phase ll, the RP2D in phase lb will be used. Capecitabine: fixed dose as an oral administration, 1250mg/m2 BID on day 1 to 14 followed by 7 days off

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-10-31
• Completion: 2024-08-31
• First posted: 2021-02-12
• Last updated: 2023-10-31