NCT06941766 Iparomlimab and Tuvonralimab (QL1706) for Intermediate Trophoblastic Tumors
| NCT ID | NCT06941766 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Intermediate Trophoblastic Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-04-15 |
| Primary Completion | 2027-04-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2025-04-15 with a primary completion date of 2027-04-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: Females aged 18-70 years. Histologically confirmed placental site trophoblastic tumor (PSTT) or epitheloid trophoblastic tumor (ETT) For Cohort A: Stage IV disease (treatment-naïve）, recurrent, or chemotherapy-resistant disease For Cohort B: Stage I-III disease requiring adjuvant chemotherapy post-biopsy/surgery, meeting ≥1 of: Abnormal β-hCG 2 weeks post-surgery; Incomplete resection; High-risk features includes: Interval from last pregnancy ≥48 months; Deep myometrial invasion; Mitotic count \>5/HPF; Tumor necrosis. ECOG score 0-1. Signed informed consent. Organ Function Requirements: Hematologic: WBC ≥3.0×10⁹/L ANC ≥1.5×10⁹/L Platelets ≥80×10⁹/L Hemoglobin ≥8.0 g/dL Creatinine ≤1.5×ULN Total bilirubin ≤1.5×ULN (or direct bilirubin ≤ULN if total bilirubin \>1.5×ULN) AST/ALT ≤2.5×ULN INR/PT/aPTT ≤1.5×ULN (or within therapeutic range if on anticoagulants). Exclusion Criteria: Life expectancy \<3 months. Non-gestational trophoblastic tumors. Active malignancy (except if cured ≥3 years prior). Prior immune checkpoint therapy (anti-PD-1/L1, CTLA-4, ICOS, CD40, etc.) or cell-based immunotherapies. Active autoimmune disease requiring systemic treatment (past 2 years). Exceptions: Hormone replacement (e.g., thyroxine), physiologic corticosteroids (≤10 mg/day prednisone equivalent). Active inflammatory bowel disease (e.g., Crohn's, ulcerative colitis). Systemic corticosteroids (\>10 mg/day prednisone equivalent) within 14 days. Allowed: Topical/inhaled steroids, prophylactic steroids for contrast allergy. HIV/AIDS. Active hepatitis: HBV DNA \>1,000 IU/mL (unless on stable antiviral therapy with DNA \<1,000 IU/mL). HCV RNA-positive (unless cured). Active tuberculosis (screening required if suspected). Uncontrolled severe infection (e.g., sepsis, pneumonia requiring hospitalization). Cardiovascular disease: NYHA Class III/IV heart failure or LVEF \<50%. Uncontrolled hypertension (≥140/90 mmHg despite treatment). Unstable angina, myocardial ischemia, or arterial thromboembolism (≤6 months). Interstitial lung disease (history or active). Malabsorption syndromes (e.g., chronic diarrhea, bowel obstruction) or GI perforation/fistula (≤6 months). Psychiatric/social conditions impairing consent or compliance. Allogeneic transplant history. Live vaccines ≤30 days prior to QL1706 or planned during study. Hypersensitivity to monoclonal antibodies or protocol-specified chemotherapies. Pregnancy/lactation. Other conditions deemed to compromise patient safety or study integrity.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06941766 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Intermediate Trophoblastic Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06941766 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06941766 currently recruiting?
Yes, NCT06941766 is actively recruiting participants. Contact the research team at liyuan10833@pumch.cn for enrollment information.
Where is the NCT06941766 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06941766 clinical trial?
NCT06941766 is sponsored by Peking Union Medical College Hospital. The trial plans to enroll 20 participants.