NCT04965519

A Study of RC48-ADC for the Treatment of HER2-expressing Gynecological Malignancies

An Open, Multi-cohort, Multi-center Phase II Basket Clinical Study of RC48-ADC Monotherapy in the Treatment of HER2-expressing (HER2-positive and HER2 Low Expression) Gynecological Malignancies

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the effectiveness and safety of intravenous injection of RC48-ADC in the treatment of HER2 expression (HER2 positive and HER2 low expression) gynecological malignancies.

Detailed description

This study is an open, multi-cohort, multi-center Phase II basket clinical study that included HER2 expression (HER2 positive and HER2 low expression) gynecological malignant tumor subjects. The four cohorts include cervical cancer, ovarian epithelial cancer、 fallopian tube cancer and primary peritoneal cancer, endometrial cancer and other gynecological malignancies (vulvar cancer, vaginal cancer, primary sarcoma of the gynecological reproductive system, etc.). Each cohort enrolled 30 subjects. Among them, IHC+, IHC2+, IHC3+ subjects were enrolled at least 5 subjects, and the remaining 15 subjects were not restricted by HER2 expression. HER2 expression includes HER2 positive and HER2 low expression. HER2 positive is defined by the immunohistochemical IHC 2+/fluorescence in situ hybridization technique FISH+ or IHC 3+ judged by the central laboratory. HER2 low expression is defined as IHC 2+/FISH- or IHC+ as determined by the central laboratory. The Molecular Pathology Department of the Department of Pathology, Cancer Hospital of the Chinese Academy of Medical Sciences will serve as the research center laboratory to confirm the HER2 status (including IHC and FISH tests).

Conditions

• Gynecological Malignancy

Interventions

Type	Name	Description
DRUG	RC48-ADC	2.0mg/kg IV every 2 weeks

Timeline

• Start date: 2021-12-21
• Primary completion: 2024-10-01
• Completion: 2025-06-01
• First posted: 2021-07-16
• Last updated: 2023-12-18

Locations

1 site across 1 country: China