NCT04264936

A Study of RC48-ADC(Antibody Drug Conjugate) and JS001 to Evaluate the Safety and Pharmacokinetics of Subjects With Locally Advanced or Metastatic Urothelial Cancer

A Open-label, Single-arm, Phase Ib/II Study of RC48-ADC and JS001 to Evaluate the Safety and Pharmacokinetics of Subjects With Locally Advanced or Metastatic Urothelial Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm, Phase Ib/II investigator-initiated trial of RC48-ADC combined with JS001 to evaluate the safety and pharmacokinetics of subjects with locally advanced or metastatic urothelial cancer

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	RC48-ADC and JS001	Recombinant Humanized anti-HER2(Human epidermal growth factor receptor-2) Monoclonal Antibody-MMAE(Monomethyl Auristatin E) Conjugate For Injection and JS001 Injection

Timeline

• Start date: 2020-02-15
• Primary completion: 2021-01-30
• Completion: 2021-12-31
• First posted: 2020-02-11
• Last updated: 2020-02-13

Locations

1 site across 1 country: China