Clinical Trials Logo

Clinical Trial Summary

This is a non-randomized, open-label, single-arm, multicenter Phase I clinical trial which will evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of RC48-ADC in combinaton with Anti-PD1 Monoclonal Antibody in Treatment of HER2-Positive Advanced Malignant Solid Tumors.


Clinical Trial Description

The study has 2 parts which include dose escalation phase and dose extension phase. Dose escalation will use a 3+3 design and will enroll cohorts of 3-6 patients with HER2-Positive Advanced Malignant Solid Tumors sequentially at escalating doses of 2.0mg/kg and 2.5mg/kg to RC48-ADC and JS001 is fixed dose of 3.0mg/mg . Escalation will continue until identification of a MTD. Dose of phase II and extenstion stage which based-results of escalation phase will be recommend. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04280341
Study type Interventional
Source Peking University
Contact lin Shen, professor
Phone 86-10-88196561
Email linshenpku@163.com
Status Recruiting
Phase Phase 1
Start date June 3, 2020
Completion date December 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04189211 - A Clinical Trial of BAT8001 on Safety, Tolerability and Pharmacokinetics for Patients Phase 1
Active, not recruiting NCT04278144 - A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04660929 - CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors Phase 1
Completed NCT04521179 - Study of KN026 Combined With KN046 in Patients With Locally Advanced HER2-positive Solid Tumors Phase 2
Not yet recruiting NCT04501770 - A Study of M802 (HER2 and CD3) in HER2-Positive Advanced Solid Tumors Phase 1