drugset / Trial / NCT06941766
Iparomlimab and Tuvonralimab (QL1706) for Intermediate Trophoblastic Tumors
Phase 1/2
Recruiting
20 enrolled
Peking Union Medical College Hospital
Dalian women and children's medical group · collabGansu Provincial Maternal and Child Health Care Hospital · collabHenan Cancer Hospital · collabObstetrics & Gynecology Hospital of Fudan University · collabShengjing Hospital · collabSichuan Cancer Hospital and Research Institute · collabSun Yat-Sen Memorial Hospital of Sun Yat-Sen University · collabThe First Affiliated Hospital of Xiamen University · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-04-15
- Primary completion
- 2027-04-16
- Completion
- 2028-04-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | QL1706 | Monoclonal antibody | 5 mg/kg | Intravenous |