NCT05601401

Phase II Study of RC48-ADC in Treating Patients With Salivary Gland Tumors Expressing HER2

Phase II Clinical Study to Assess the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody MMAE Coupling Agent in Treating Patients With Locally Advanced or Metastatic Salivary Gland Tumors Expressing HER2

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about the efficacy and safety of RC48-ADC, a HER2-targeting antibody-drug conjugate, in patients with HER2-positive and HER2-low expressing advanced or metastatic salivary cancer.

Detailed description

The goal of this clinical trial is to learn about the efficacy and safety of RC48-ADC, a HER2-targeting antibody-drug conjugate, in patients with HER2-positive and HER2-low expressing advanced or metastatic salivary cancer. Participants will receive RC48-ADC 2.0 mg/kg intravenous (IV) infusion each 14-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination.

Conditions

• Salivary Gland Tumors

Interventions

Type	Name	Description
DRUG	RC48-ADC	RC48-ADC 2.0 mg/kg IV every 14 days

Timeline

• Start date: 2022-03-31
• Primary completion: 2023-03-31
• Completion: 2023-12-31
• First posted: 2022-11-01
• Last updated: 2022-11-01

Locations

1 site across 1 country: China