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Iparomlimab and Tuvonralimab (QL1706) for Intermediate Trophoblastic Tumors

NCT06941766 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-04-30

No results posted yet for this study

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

DRUG

QL1706

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

DRUG

Chemotherapy

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

Sponsors & Collaborators

  • Shengjing Hospital

    collaborator OTHER

  • Obstetrics & Gynecology Hospital of Fudan University (Shanghai Red House Ob & Gyn Hospital)

    collaborator UNKNOWN

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    collaborator OTHER

  • Henan Cancer Hospital

    collaborator OTHER_GOV

  • Gansu Provincial Maternal and Child Health Care Hospital

    collaborator OTHER

  • Dalian women and children's medical group

    collaborator UNKNOWN

  • The First Affiliated Hospital of Xiamen University

    collaborator OTHER

  • Sichuan Cancer Hospital and Research Institute

    collaborator OTHER

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-15
Primary Completion
2027-04-16
Completion
2028-04-16

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06941766 on ClinicalTrials.gov