NCT07009145尚未招募2 期
An Exploratory Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Bevacizumab for the Treatment of Unresectable or Metastatic MSI-H/dMMR Colorectal Cancer
Qianfoshan Hospital1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2025年6月27日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
This is a single-arm, multi-center, exploratory study evaluating the efficacy and safety of iparomlimab and tuvonralimab (QL1706) in combination with bevacizumab for the treatment of patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) unresectable or metastatic colorectal cancer. Eligible participants who meet the inclusion and exclusion criteria will provide written informed consent and receive QL1706 at 5.0 mg/kg and bevacizumab at 7.5 mg/kg on Day 1 of every 3-week cycle (Q3W), until disease progression or completion of 2 years of treatment. The primary endpoint of this study is objective response rate (ORR). Secondary endpoints include disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), PFS and OS rates at 6, 12, and 24 months, and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily signs the informed consent form.
- •Aged between 18 and 80 years (inclusive) at the time of consent; no gender restriction.
- •Histologically confirmed unresectable locally advanced or metastatic colorectal cancer.
- •At least one measurable target lesion according to RECIST v1.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •No prior immunotherapy for unresectable locally advanced or metastatic colorectal cancer.
- •If previously treated with standard neoadjuvant or adjuvant therapy, the interval from the last dose to the first study treatment must be ≥ 6 months.
- •Willing and able to provide tumor tissue and blood samples for MSI, RAS, BRAF, and PD-L1 testing.
- •Estimated life expectancy of ≥ 12 months.
- •Appropriate laboratory values must be met at screening.
- •Female participants must be non-lactating, and have a negative pregnancy test result prior to enrollment.
- •Participants of childbearing potential must agree to use effective contraception from the time of informed consent until at least 180 days after the last dose of study treatment.
排除标准
- •Known history of severe allergic reactions to iparomlimab and tuvonralimab or bevacizumab.
- •Active malignancy other than colorectal cancer within 5 years prior to first treatment.
- •Large tumor lesions, especially those previously irradiated, with signs of bleeding.
- •Imaging showing tumor invasion of major blood vessels (e.g., pulmonary artery or superior vena cava), including encasement or invasion of the vessel lumen.
- •Brain metastases (asymptomatic or treated symptomatic brain metastases stable for >4 weeks allowed).
- •Active autoimmune disease requiring systemic treatment.
- •Active pulmonary diseases such as tuberculosis, radiation pneumonitis, drug-induced pneumonitis, or severe pulmonary dysfunction during screening.
- •Requirement for long-term or high-dose NSAIDs (aspirin >325 mg) or anticoagulant therapy.
- •History of severe gastrointestinal events within 6 months prior to first treatment.
- •Severe intestinal obstruction symptoms or signs and unretrieved intestinal stents at screening.
- •Cardiovascular or cerebrovascular diseases including but not limited to: NYHA class > II heart failure; unstable or severe angina; myocardial infarction or stroke within 6 months; atrial fibrillation or other arrhythmias requiring treatment; symptomatic superior vena cava syndrome; prolonged QT interval (male QT > 450 ms; female QTc > 470 ms); uncontrolled hypertension despite medication (SBP >140 mmHg and/or DBP >90 mmHg) or history of hypertensive crisis or encephalopathy.
- •Known bleeding disorders or coagulopathies.
- •Uncontrolled pleural, pericardial, or ascitic effusions requiring drainage.
- •Active infection or unexplained fever >38.5°C at screening (cancer-related fever allowed).
- •Use of systemic broad-spectrum antibiotics within 30 days prior to first treatment.
- •Systemic corticosteroids (>10 mg prednisone equivalent daily) or immunosuppressants within 14 days prior to first treatment, or immunostimulants within 4 weeks.
- •Major surgery, severe fractures, or therapeutic clinical trials within 4 weeks prior to first treatment; herbal treatment within 2 weeks.
- •Ongoing adverse events from prior antitumor therapy greater than grade
- •HIV infection, other congenital or acquired immunodeficiencies, or history of organ or allogeneic bone marrow transplantation (except corneal transplantation).
- •Positive hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) with HBV DNA >10⁴ copies/mL (~2000 IU/mL); or positive hepatitis C antibody with HCV RNA >10³ copies/mL; co-infection with HBV and HCV excluded.
- •Vaccination with live or attenuated vaccines within 30 days prior to first treatment.
- •Prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-OX-40, anti-CD137).
- •Prior adjuvant targeted therapy against EGFR, VEGF, or VEGFR (e.g., bevacizumab, cetuximab, panitumumab, apatinib, regorafenib, anlotinib).
- •Psychiatric disorders, epilepsy, dementia, or substance abuse that may affect compliance.
- •Other conditions or lab abnormalities that may interfere with study participation or confound results as judged by investigators or sponsors.
研究组 & 干预措施
QL1706 + Bevacizumab
Experimental
干预措施: QL1706 (Drug)
QL1706 + Bevacizumab
Experimental
干预措施: Bevacizumab (Drug)
结局指标
主要结局
ORR
时间窗: approximately 6 months after the last subject participating in
The proportion of subjects with complete response (CR) and partial response (PR) according RESIST1.1 in total subjects
次要结局
- DCR(approximately 12 months after the last subject participating in)
- DOR(approximately 12 months after the last subject participating in)
- PFS(approximately 12 months after the last subject participating in)
- 6/12/24 PFS rate(6/12/24 months after the last subject participating in)
- OS(approximately 12 months after the last subject participating in)
- 6/12/24 OS rate(6/12/24 months after the last subject participating in)
- Safety (adverse event)(Up to approximately 2 years)
研究者
Jun Wang
Associate Director, Department of Oncology
Qianfoshan Hospital
研究点 (1)
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