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RECRUITING
NCT06941766
PHASE1/PHASE2

Iparomlimab and Tuvonralimab (QL1706) for Intermediate Trophoblastic Tumors

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-04-15

Completion Date

2028-04-16

Last Updated

2025-04-30

Healthy Volunteers

No

Interventions

DRUG

QL1706

5 mg/kg, IV infusion, Q3W (D1)

DRUG

Chemotherapy

FAEV, EMA/EP, EMA/CO, or TP/TE.

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China