Iparomlimab and Tuvonralimab (QL1706) for Intermediate Trophoblastic Tumors

NCT06941766 | Recruiting Phase 1

• 1 other identifier: ITT01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Intermediate Trophoblastic Tumor

Outcome Measures

Primary Outcomes (1)

• Complete Response (CR) Rate

  Percentage of patients achieving CR, as defined by normalization of serum hCG (≤5 IU/L for ≥4 weeks)

  up to one year

Secondary Outcomes (9)

• Objective Response Rate (ORR)

  up to one year

• Disease Control Rate (DCR)

  up to one year

• Rate of Progression-Free Survival (PFS)

  up to one year

• Rate of Overall Survival (OS)

  up to one year

• Concentration of anti-Müllerian hormone (AMH) to assess ovarian function

  up to one year

Study Arms (1)

QL1706±chemo

EXPERIMENTAL

Cohort A: QL1706: 5 mg/kg, intravenous (IV) infusion, every 3 weeks (Q3W), administered on Day 1 (D1).Chemotherapy Options: FAEV, EMA/EP, EMA/CO, or TP/TE. Cohort B: QL1706: 5 mg/kg, IV infusion, Q3W (D1).

Drug: QL1706; Drug: Chemotherapy

Interventions

QL1706 DRUG

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

QL1706±chemo

Chemotherapy DRUG

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

QL1706±chemo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: ITT only occurs in women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Shengjing Hospital: collaborator
• Obstetrics & Gynecology Hospital of Fudan University (Shanghai Red House Ob & Gyn Hospital): collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Henan Cancer Hospital: collaborator
• Gansu Provincial Maternal and Child Health Care Hospital: collaborator
• Dalian women and children's medical group: collaborator
• The First Affiliated Hospital of Xiamen University: collaborator
• Sichuan Cancer Hospital and Research Institute: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Yuan Li

CONTACT

+8617810376318; liyuan10833@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 24, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): April 16, 2027
• Study Completion (Estimated): April 16, 2028
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)