NCT06063018

RC48 Combined With Tislelizumab for Second-line Treatment of HER2 Expression in Recurrent Cervical Cancer

A Single-arm, Single Center, Phase II Study of RC48 Combined With Tislelizumab for Second-line Treatment of HER2 Expression in Recurrent Cervical Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

There is currently no standardized treatment for patients who have undergone first-line standard treatment. In this study, We investigated the efficacy and safty of RC48 combined with Tislelizumab in the second-line treatment of patients with HER2 expression in recurrent cervical cancer.

Detailed description

This study is a single-arm, single center II study，aim to evaluate the effective and safe of RC48 combined with Tislelizumab in the second-line treatment of patients with HER2 expression in recurrent cervical cancer. This study set up a safety introduction period, that is, the first 6 subjects enrolled in the study will be slowly monitored for safety. The monitoring time window was 28 days after first receiving the study drug. If Dose limit toxicity (DLT) is observed in ≥2 of the first 6 subjects and is assessed by the investigator team to be related to RC48 therapy, the initial dose of RC48 therapy in subsequent enrolled patients is adjusted to 1.5 mg/kg Q2W. During the safety induction period, if a subject does not complete the safety assessment for the tolerability observation period (within 28 days after the first dose) for reasons other than dose tolerance, a new subject will be replaced. After the safety introduction period, any enrolled subjects who withdraw early from the trial will not be allowed to be replaced by additional enrolled subjects. The number corresponding to the subject is not allowed to be reused by other new subjects.

Conditions

• Cervical Cancer Recurrent

Interventions

Type	Name	Description
DRUG	RC48 + Tislelizumab	RC48: intravenous drip, 2mg/kg, D1, repeated once every 2 weeks. Tislelizumab: intravenous drip, fixed dose 600 mg, D1, repeated once every 6 weeks.

Timeline

• Start date: 2023-08-16
• Primary completion: 2025-08-01
• Completion: 2026-08-01
• First posted: 2023-10-02
• Last updated: 2023-10-02

Locations

1 site across 1 country: China