RecruitingPhase 1Phase 2NCT06941766

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


Sponsor

Peking Union Medical College Hospital

Enrollment

20 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Chemotherapy and a drug called QL1706 for people with intermediate trophoblastic tumor. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGQL1706

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

DRUGChemotherapy

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


Locations(1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

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NCT06941766