NCT06941766

Iparomlimab and Tuvonralimab (QL1706) for Intermediate Trophoblastic Tumors

Efficacy and Safety of Iparomlimab and Tuvonralimab (QL1706) in the Treatment of Intermediate Trophoblastic Tumors: A Prospective, Multicenter, Single-arm Trial

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial aims to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (QL1706), a dual-targeting immunotherapy (anti-PD-1/CTLA-4), in patients with intermediate trophoblastic tumors (ITT). The main questions it aims to answer are: Does QL1706 improve complete response (CR) rates (primary endpoint) and survival outcomes? What are the safety profiles of QL1706 in ITT, including immune-related adverse events? Participants will receive QL1706 (5 mg/kg IV, Q3W) ± chemotherapy (FAEV/EMA/EP/EMA/CO/TP-TE). They will also receive Maintenance therapy post-hCG normalization. Efficacy is assessed via serial β-hCG tests, imaging (every 9-12 weeks), and biomarker analysis.

Conditions

• Intermediate Trophoblastic Tumor

Interventions

Type	Name	Description
DRUG	QL1706	5 mg/kg, IV infusion, Q3W (D1)
DRUG	Chemotherapy	FAEV, EMA/EP, EMA/CO, or TP/TE.

Timeline

• Start date: 2025-04-15
• Primary completion: 2027-04-16
• Completion: 2028-04-16
• First posted: 2025-04-24
• Last updated: 2025-04-30

Locations

1 site across 1 country: China