Iparomlimab and Tuvonralimab (QL1706) for Intermediate Trophoblastic Tumors

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Apr 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called QL1706, which combines two immunotherapy drugs, Iparomlimab and Tuvonralimab, to see how well it works for women with intermediate trophoblastic tumors (ITT). The main goals of the trial are to find out if this treatment can help patients achieve complete remission (meaning no signs of the tumor) and improve their overall survival. Participants in the trial will receive QL1706 through an intravenous (IV) infusion every three weeks, and some may also receive additional chemotherapy. Researchers will monitor the effectiveness of the treatment through blood tests and imaging scans over time.

To be eligible for the trial, women between the ages of 18 and 70 must have a confirmed diagnosis of specific types of trophoblastic tumors. They should also meet certain health criteria, such as having good organ function and not having active severe infections or other serious health issues. Participants will need to provide informed consent before joining the study. It’s important to note that this trial is currently recruiting participants, and those who join can expect close monitoring and support throughout the treatment process.

Gender

FEMALE

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.