NCT05493683

Disitamab Vedotin Combined With Tislelizumab in Advanced HER2 Positive Colorectal Cancer

A Single Arm, Open Label, Multiple Center, Prospective Study of Disitamab Vedotin Combined With Tislelizumab in HER2 Positive Advanced Colorectal Cancer Failed at Least Two Lines of Systemic Treatment.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Among patients with colonrectal cancer, 5% were HER-2 positive, but the immunohistochemical results were mostly HER-2 2 +, which did not meet the indications of HER-2 targeting drugs. Disitamab Vedotin , which was listed in China last year, achieved similar results in HER-2 2+ and 3+, according to a clinical trial for breast cancer, suggesting that patients with colonrectal cancer may benefit from it. Tislelizumab is a PD-1 monoclonal antibody, which has been approved for a variety of tumors. It was reported that anti-HER-2 treatment can improve the tumor immune microenvironment and improve the efficacy of immunotherapy. At the same time, our previous studies showed that anti-PD-1 combined with Disitamab Vedotin can significantly inhibit the growth of colon tumor in mice. Therefore, Disitamab Vedotin and Tislelizumab were used in this study. This prospective clinical trial may bring new hope for the treatment of HER-2 positive CRC patients.

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
DRUG	Disitamab vedotin	2.0mg/kg，q2w
DRUG	Tislelizumab	400mg，q6w

Timeline

• Start date: 2022-08-01
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2022-08-09
• Last updated: 2022-10-21

Locations

6 sites across 1 country: China