NCT07172217

The Efficacy and Safety RC48 Plus QL1706 in Second-Line Treatment of HER2-Expressing Recurrent CC

Clinical Study on the Efficacy and Safety of Disitamab Vedotin Combined With Iparomlimab and Tuvonralimab in the Second-Line Treatment of HER2-Expressing Recurrent Cervical Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm study. The efficacy and safety of Disitamab Vedotin combined with Apalutamide and Toripalimab in the second-line treatment of HER2-expressing recurrent cervical cancer are evaluated based on the following indicators: Primary evaluation indicator: Objective Response Rate (ORR) Secondary evaluation indicators: Efficacy-related indicators: Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DOR), Overall Survival (including median Overall Survival \[mOS\] and 1-year, 2-year, 3-year Overall Survival rates) Safety-related indicators: Adverse Events (AEs) and Serious Adverse Events (SAEs).

Detailed description

This study is a multicenter, open-label, single-arm, exploratory trial. It enrolls 33 participants with recurrent cervical cancer who have HER2 expression (IHC 1+, 2+, or 3+). After eligible participants are enrolled, they will receive treatment with RC48 (dose: 2.5mg/kg, Q3W, intravenous infusion) in combination with QL1706 (dose: 5mg/kg, Q3W, intravenous infusion), with a treatment window of ±3 days. During the study, safety assessment and efficacy assessment will be conducted. Safety Assessment For participants who have received at least one dose of the study drug, the safety assessment will start from the administration of the study drug. It will be performed before each drug administration, assessed once every 3 weeks (with a window of ±3 days), and continue until 30 days after the last dose of the study drug or the initiation of new anti-tumor treatment. Efficacy Assessment Tumor assessment will be conducted in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Starting from the administration of the study drug, assessments will be performed once every 6 weeks (with a window of ±3 days) until the occurrence of intolerable toxicity or radiologically confirmed disease progression. For participants who experience disease progression or start other anti-tumor treatments, survival follow-up will be conducted once every 3 months (with a window of ±14 days) from the date of confirmation. Information on the participants' subsequent anti-tumor treatment and survival status will be collected until the participant's death, withdrawal of informed consent, loss to follow-up, study termination, whichever occurs first.

Conditions

• Recurrent Cervical Cancer

Interventions

Type	Name	Description
DRUG	RC48	Disitamab Vedotin (RC48) : 2.5 mg/kg, administered once every 3 weeks (Q3w), via intravenous infusion on Day 1 of each treatment cycle
DRUG	QL1706	Drug: QL1706 Iparomlimab and Tuvonralimab (QL1706) : 5 mg/kg in total, administered once every 3 weeks (Q3w), via intravenous infusion on Day 1 of each treatment cycle

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-02-28
• Completion: 2028-12-31
• First posted: 2025-09-15
• Last updated: 2025-09-15

Locations

1 site across 1 country: China