NCT06873854尚未招募2 期
Evaluation of a Phase II, Single-arm, Multicenter, Open-label Clinical Study on LM-108 Injection in Combination With Toripalimab for Advanced Malignant Solid Tumors in Patients With Unresectable or Metastatic Microsatellite Highly Unstable (MSI H) or Mismatch Repair Defects (dMMR) Who Have Failed Previous Treatment With Anti-PD-1/PD-L1 Drugs
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
Based on overall response rate (ORR) as assessed by the Independent Review Committee (IRC) against the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria for Solid Tumor Efficacy, To evaluate the efficacy of LM-108 in combination with Toripalimab in patients with advanced malignant solid tumours with unresectable or metastatic MSI-H/dMMR who have failed previous anti-PD-1 /PD-L1 therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with advanced solid tumors diagnosed by pathology have evidence of advanced stage or metastasis that cannot be surgically removed. And the MSI-H status will be confirmed by central laboratory designated of the sponsor.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •At least one measurable lesion.
- •Subjects who have failed previous monotherapy with anti-PD-1/PD-L1 drugs or combination (synchronous or sequential) with other systemic treatments and unresectable or metastatic late stage MSI-H/dMMR solid tumors.
- •Subjects must have Archived Samples or fresh tumor tissue specimens are required for testing.
- •Any adverse event from prior anti-tumor therapy and surgery has recovered to ≤ grade 1 of CTCAE v5.
- •Subjects must show appropriate organ and marrow function in laboratory examinations.
- •Women of childbearing potential (WOCBP) and Male participants must agree to use one medically recognized contraceptive measures of contraception, during the study and for 6 months after the last dose of study drug.
- •Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
排除标准
- •Subjects with symptomatic/active central nervous system (CNS) metastases.
- •Subject who have uncontrollable pleural effusion, pericardial effusion, and ascites despite treatment such as puncture and drainage Within 14 days prior to enrollment; Pericardial effusion accompanied by clinical symptoms or moderate or above.
- •Subjects' weight decreased by more than 20% within the first 2 months of enrollment.
- •Poorly controlled tumor-related pain.
- •Subjects who received anti-tumour treatment, , major surgery, immunosuppressive drugs and live attenuated vaccines before enrollment.
- •Subjects have received anti-tumor immunotherapy and experienced ≥ grade 3 immune related adverse events (irAE) or ≥ grade 2 immune related myocarditis.
- •Subjects who have other cancers within 5 years prior to entering the research.
- •Previous or current known autoimmune disease.
- •Within the first 3 months of enrollment, there have been significant clinical bleeding symptoms or clear bleeding tendencies; Arterial/venous thrombotic events that occurred within the first 6 months of enrollment.
- •Present peripheral neuropathy of grade>1 .
- •Subjects who have a history of gastrointestinal perforation and/or gastrointestinal fistula within the 6 months prior to enrollment.
- •Subjects who have been clinical signs or symptoms of intestinal obstruction and/or gastrointestinal obstruction Within 6 months prior to starting the study treatment.
- •Presence of interstitial lung disease, non infectious pneumonia, or uncontrolled systemic diseases.
- •Known to be allergic to the investigational drug or any of its excipients; Or have experienced severe allergic reactions to other monoclonal antibodies.
- •HIV infection, active HBV or HCV infection.
- •Subject who have clinical symptoms or diseases of the heart that have not been well controlled.
- •Subjects who take Systemic use of antibiotics for more than 7 days within the first 4 weeks prior to enrollment, or unexplained fever>38.5 ° C during screening/before first administration .
- •Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- •Subjects who have participated in any other drug clinical studies within 4 weeks prior to enrollment, or have not exceeded 5 half lives since the last study medication.
- •Known history of abuse or drug use of psychotropic substances.
- •Subjects who have other serious physical or mental illnesses or laboratory abnormalities and judged as not eligible to participate in this study by the investigator.
研究组 & 干预措施
LM-108 in Combination with Toripalimab
Experimental
干预措施: LM-108 (Drug)
LM-108 in Combination with Toripalimab
Experimental
干预措施: Toripalimab (Drug)
结局指标
主要结局
ORR
时间窗: 104 weeks
Overall Response Rate assessed by Independent Review Committee against the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
次要结局
- PFS(104 weeks)
- OS(104 weeks)
- AEs(104 weeks)
- SAEs(104 weeks)
- ORR(104 weeks)
- OS rates(104 weeks)
- Temperatures(104 weeks)
- Pulse in BPM(104 weeks)
- Blood Pressure(104 weeks)
- Weight(104 weeks)
- AE/SAE(104 weeks)
- DCR(104 weeks)
- DOR(104 weeks)
- Progression-free survival Rates(104 weeks)
- Height(104 weeks)
- Complete Blood Count(104 weeks)
- Urine Routine test(104 weeks)
- Blood biochemistry(104 weeks)
- Coagulation function(104 weeks)
- Thyroid function(104 weeks)
- Stool routine examination(104 weeks)
- Virological examination(104 weeks)
- Pregnancy check(104 weeks)
- LVEF(104 weeks)
- HR(104 weeks)
- RR(104 weeks)
- PR(104 weeks)
- QRS(104 weeks)
- QT(104 weeks)
- QTcF(104 weeks)
- ECOG score(104 weeks)
研究者
研究点 (1)
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