NCT05661357

Disitamab Vedotin Combined With Fruquintinib for mCRC With HER2 Expression

Single Arm, Prospective, Exploratory Clinical Study of Disitamab Vedotin Combined With Fruquintinib for Advanced Colorectal Cancer With HER2 Expression or Mutation That Has Received at Least Two Standard Treatment Failures

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Zhongnan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Single arm, prospective, exploratory clinical study of Disitamab Vedotin combined with Fruquintinib for advanced colorectal cancer with HER2 expression or mutation that has received at least two standard treatment failures

Detailed description

Colorectal cancer is the fourth deadliest malignant tumor in the world, and the 5-year survival rate of patients with advanced colorectal cancer is only 12%. In September 2018, furoquentinib was the first approved in China for the treatment of metastatic colorectal cancer patients who failed to receive at least two systematic anti-tumor treatments. The FRESCO trial is a multicenter (28 hospitals in China), randomized, double-blind and placebo controlled phase III trial, The median OS of patients receiving furoxigenib was 9.3 months, while the mOS of patients receiving placebo was 6.57 months (HR=0.65, 95% CI: 0.51\~0.83, P\<0.001); As a secondary endpoint, mPFS was 3.71 and 1.84 months (HR=0.26, 95% CI: 0.21\~0.34, P\<0.001). In order to further improve the efficacy, it is necessary to continue to explore the combined treatment strategy of furoquentinib: combined chemotherapy, other targeted treatment and local treatment may benefit more CRC patients. HER2 amplification or overexpression was found in 2%\~6% of patients with advanced or metastatic colorectal cancer. In the past decade, several studies have identified it as a potential target for the treatment of HER2 positive colorectal cancer, and it has been written into the guidelines for posterior line therapy. The prognostic value of HER2 overexpression in advanced colorectal cancer is still unclear. The anti-tumor activity of dual targeted HER2 treatment schemes, such as Patuzumab+Trastuzumab, Trastuzumab+Tucatinib, Trastuzumab+Lapatinib, has been significantly increased, which has been confirmed in clinical studies. Vidiximab contains a new humanized anti HER2 antibody Disitamab, which is coupled to monomethylolestatin E (MMAE) through a cleavable linker. Its antibody has a high affinity for HER2 and can efficiently bind with it and enter cancer cells; The linker is cleavable in the tumor cell membrane, which can rapidly release small molecule cytotoxic drugs, and has a bystander killing effect against heterogeneous tumor cells. This one arm, prospective, open study was designed to explore the efficacy and safety of vidiximab combined with furoquentinib triple line or above in the treatment of advanced colorectal cancer with HER2 expression or mutation.

Conditions

• HER2
• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Disitamab Vedotin Combined With Fruquintinib	Furquinotinib: 3mg, Qd, 28 days as a cycle. Vidicizumab: according to the instructions of Vidicizumab, d1, 2.5 mg/kg, intravenous drip (ivgtt)

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-01-31
• Completion: 2025-12-31
• First posted: 2022-12-22
• Last updated: 2024-04-17

Locations

1 site across 1 country: China