NCT05940896

RC48-ADC Combined With Radiotherapy in the Treatment of Locally Advanced Solid Tumors With HER2 Expression

Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of Disitamab Vedotin Intravenously Combined With Radiotherapy in the Treatment of Locally Advanced Solid Tumors With HER2 Expression Phase 1 Study

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of Disitamab Vedotin(DV, RC48-ADC) intravenously combined with radiotherapy in the treatment of locally advanced solid tumors with HER2 expression

Detailed description

This study is a single arm, open, single site clinical study aimed at evaluating the safety, tolerability, pharmacokinetic characteristics, and efficacy of Disitamab Vedotin intravenously combined with radiotherapy in the treatment of locally advanced solid tumors with HER2 expression. Unresectable locally advanced solid tumor patients whose SOC is concurrent chemoradiation but ineligible or refuse to standard chemotherapy should be enrolled.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Disitamab vedotin	Disitamab Vedotin intravenously combined with radiotherapy (concurrent)

Timeline

• Start date: 2023-06-29
• Primary completion: 2024-11-16
• Completion: 2027-02-28
• First posted: 2023-07-11
• Last updated: 2023-11-27

Locations

1 site across 1 country: China