Intermediate Trophoblastic TumorPhase 1/2NCT06941766
Iparomlimab and Tuvonralimab (QL1706) for Intermediate Trophoblastic Tumors
A Phase 1/2 study testing QL1706 and Chemotherapy in people with Intermediate Trophoblastic Tumor, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Intermediate Trophoblastic Tumor
- What is being tested?
- QL1706 and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2025to 16 Apr 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yang Xiang, 01069156068
About this study
Official title: Efficacy and Safety of Iparomlimab and Tuvonralimab (QL1706) in the Treatment of Intermediate Trophoblastic Tumors: A Prospective, Multicenter, Single-arm Trial
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
- Being tested
- QL1706, Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1706Drug
5 mg/kg, IV infusion, Q3W (D1)
ChemotherapyDrug
FAEV, EMA/EP, EMA/CO, or TP/TE.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: QL1706; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) Rate
Percentage of patients achieving CR, as defined by normalization of serum hCG (≤5 IU/L for ≥4 weeks)
Measured: up to one year
Secondary outcomes (9)
Objective Response Rate (ORR)
Proportion of evaluable patients achieving CR + Partial Response (PR) (serum hCG decline >50% from baseline but without normalization)
Measured: up to one year
Disease Control Rate (DCR)
Proportion of evaluable patients with CR + PR + Stable Disease (SD) (serum hCG fluctuation ≤50% from baseline)
Measured: up to one year
Rate of Progression-Free Survival (PFS)
Time from treatment initiation to radiographic progression (RECIST v1.1) or death from any cause
Measured: up to one year
Rate of Overall Survival (OS)
Time from first dose to death from any cause
Measured: up to one year
Concentration of anti-Müllerian hormone (AMH) to assess ovarian function
Ovarian function as assessed by anti-Müllerian hormone (AMH)
Measured: up to one year
Number of Participants with treatment-related Adverse Events [Safety and Tolerability]
Determine frequency and severity of adverse events as assessed by NCI CTCAE (Version 5.0)
Measured: up to one year
Quality of life of cancer patients by questionnaire
Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC QLQ-C30) It consists of 30 questions across multiple scales, including a global health status scale and functional scales (physical, role, emotional, cognitive, and social functioning) to evaluate daily activities and well-being. Symptom scales cover common issues like fatigue, pain, and nausea. The tool's reliability and validity make it effective for measuring the impact of cancer and its treatments, with additional disease-specific modules available for tailored assessments.
Measured: up to one year
Cancer specific rehabilitation by questionnaire
Assessed by Cancer rehabilitation evaluation system-short form (CARES-SF) It is a brief, validated questionnaire designed to assess emotional well-being, functional status, and social support in cancer survivors. It is specifically tailored to evaluate the psychosocial and functional adjustment of individuals after cancer treatment, focusing on areas such as emotional distress, social functioning, and physical well-being. The tool is often used in oncology and rehabilitation settings to monitor the quality of life and recovery of cancer patients during and after treatment. It is concise, easy to administer, and provides valuable insights into the holistic needs of cancer survivors.
Measured: up to one year
Reproductive concerns after cancer by scale
Assessed by Reproductive Concerns After Cancer (RCAC) scale. The minimum and maximum values are 18 and 90 respectively, and a higher score means a higher level of reproductive concern or anxiety
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start15 Apr 2025
- Primary completion16 Apr 2027 (estimated)
- Study completion16 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermediate Trophoblastic TumorStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shengjing Hospital, Obstetrics & Gynecology Hospital of Fudan University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Henan Cancer Hospital, Gansu Provincial Maternal and Child Health Care Hospital, Dalian Women and Children's Medical Center, The First Affiliated Hospital of Xiamen University, Sichuan Cancer Hospital and Research Institute
- Responsible party
- Principal investigator, xiang yang, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941766
- Sponsor's protocol ID
- ITT01
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Iparomlimab and Tuvonralimab (QL1706) in the Treatment of Intermediate Trophoblastic Tumors: A Prospective, Multicenter, Single-arm Trial
- ClinicalTrials.gov ID
- NCT06941766
- Acronym / sponsor ID
- ITT01
- Conditions
- Intermediate Trophoblastic Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Shengjing Hospital, Obstetrics & Gynecology Hospital of Fudan University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Henan Cancer Hospital, Gansu Provincial Maternal and Child Health Care Hospital, Dalian Women and Children's Medical Center, The First Affiliated Hospital of Xiamen University, Sichuan Cancer Hospital and Research Institute
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 16 Apr 2027 (estimated)
- Study completion
- 16 Apr 2028 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QL1706±chemo | Experimental | Drug: QL1706, Drug: ChemotherapyCohort 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Females aged 18-70 years. Histologically confirmed placental site trophoblastic tumor (PSTT) or epitheloid trophoblastic tumor (ETT)
- Stage IV disease (treatment-naïve）, recurrent, or chemotherapy-resistant disease
- 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.
- 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).
Key exclusion criteria (10 listed)
- 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.
- HBV DNA >1,000 IU/mL (unless on stable antiviral therapy with DNA <1,000 IU/mL).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QL17065 mg/kg, IV infusion, Q3W (D1) | Drug | QL1706±chemo |
| ChemotherapyFAEV, EMA/EP, EMA/CO, or TP/TE. | Drug | QL1706±chemo |
Primary outcome
Complete Response (CR) Rate
Time frame: up to one year
Percentage of patients achieving CR, as defined by normalization of serum hCG (≤5 IU/L for ≥4 weeks)
9 secondary outcomes
Objective Response Rate (ORR)
Time frame: up to one year
Disease Control Rate (DCR)
Time frame: up to one year
Rate of Progression-Free Survival (PFS)
Time frame: up to one year
Rate of Overall Survival (OS)
Time frame: up to one year
Concentration of anti-Müllerian hormone (AMH) to assess ovarian function
Time frame: up to one year
Number of Participants with treatment-related Adverse Events [Safety and Tolerability]
Time frame: up to one year
Quality of life of cancer patients by questionnaire
Time frame: up to one year
Cancer specific rehabilitation by questionnaire
Time frame: up to one year
Reproductive concerns after cancer by scale
Time frame: up to one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing QL1706 and Chemotherapy in people with Intermediate Trophoblastic Tumor, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuan Li (+8617810376318, liyuan10833@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) Rate (time frame: up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.