NCT06490068招募中2 期
An Open, Single-arm, Phase II Clinical Study to Evaluate the Efficacy and Safety of LTC004 in Combination With Toripalimab in Patients With Advanced Solid Tumors Resistant to First-line Immunotherapy
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年6月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
To evaluate the efficacy and safety of LTC004 in combination with Toripalimab in 10 patients with advanced solid tumors resistant to first-line immunotherapy, all eligible subjects will receive LTC004 on day 1 of Week 1 and day 1 of week 3. Beginning at week 5, all subjects will receive LTC004 in combination with Toripalimab regimen until disease progression, intolerance, informed withdrawal or up to 2 years of dosing, whichever occurred first.
详细描述
All eligible subjects will receive LTC004 on day 1 of Week 1 and day 1 of week 3. Beginning at week 5, all subjects will receive LTC004 in combination with Toripalimab regimen until disease progression, intolerance, informed withdrawal or up to 2 years of dosing, whichever occurred first.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 75 years.
- •Locally advanced or metastatic solid tumors confirmed by pathology or cytology that cannot be surgically resected or can not be treated with radical concurrent chemoratherapy, and immune checkpoint inhibitor ± chemotherapy has become the standard first-line treatment, such as NSCLC, cervical cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, etc. In addition, the patients had received no more than 1 line of systemic chemotherapy and no more than 1 line of systemic PD-1/PD-L1 inhibitor treatment at the same time or successively, and the treatment failed, and the previous PD-1/PD-L1 inhibitor treatment lasted more than 6 months, the best curative effect was CR/PR; No systemic antitumor therapy other than the above treatment was received (Note: if there is a second-line standard treatment, the second-line standard treatment is required to be completed before inclusion in this trial).
- •At least one measurable tumor lesion based on RECIST V1.1 criteria.
- •Expected survival ≥12 weeks.
- •Adequate organ function.
- •Patients, both females and males, of reproductive potential must agree to use adequate contraception during and for 6 months after the last infusion.
- •Understands and provides written informed consent and willing to follow the requirements specified in protocol.
排除标准
- •History of severe hypersensitivity reactions to other mAbs.
- •Untreated, unstable or uncontrolled central nervous system (CNS) metastases with following exceptions:A. Clinically stable MRI scans and no progressive or uncontrolled neurologic symptoms or signs for at least 4 weeks prior to the first study treatment.
- •Tumor invasion of vital arteries resulting in high risk of bleeding, significant risk of perforation or already formed fistulae.
- •Patients with uncontrolled pleural effusion, pericardial effusion or abdominal effusion as judged by the investigator at screening.
- •Patients with untreated or clinically symptomatic spinal cord compression that has not been controlled.
- •Previous antitumor regimens include immunotherapy such as LAG3, TIGIT, IL-2, IL-15, CD3-like immunoagonists, and other cellular therapies.
- •≥2 malignant tumors within 5 years prior to first dose of drug.
- •irAE with ≥ grade 3 or discontinuation due to immunotherapy in the past.
- •Patients who have received any chemotherapy or anti-tumor monoclonal antibody drugs within 4 weeks prior to the first dose of study drug.small molecule targeted drugs within 2 weeks prior to the first dose of study drug; Chinese medicine therapy with clear anti-tumor indications in the package insert within 4 weeks prior to the first dose of study drug.
- •Severe infection, including but not limited to bacteremia requiring hospitalization and severe pneumonia, occurs within 4 weeks prior to the first medication; Active infection of grade CTCAE≥2 requiring treatment with systemic antibiotics was present within 2 weeks prior to the first dose.
- •The subject has active interstitial lung disease (ILD) or pneumonia; A history of needing hormones or other immunosuppressants to treat ILD or (non-infectious) pneumonia.
- •History of serious cardiovascular disease.
- •Active bleeding disorders, including gastrointestinal bleeding, as evidenced by vomiting of blood, profuse hemoptysis, or black stools, have occurred in the 6 months prior to enrollment.
- •Active hepatitis B,hepatitis C infection,syphilis infection, active tuberculosis.
- •Patients with active, or previous autoimmune disease with potential for recurrence.
- •Immunodeficiency diseases or history of such diseases, including a positive serologic test for human immunodeficiency virus (HIV).
- •Arterial/venous thrombotic events within 6 months prior to the first dose of the drug.
- •Those who received radical radiation therapy within 4 weeks prior to the first dose and those who received palliative radiation within 14 days prior to the first dose.
- •Use of live or attenuated vaccines within 4 weeks prior to the first dose,or anticipated need for live or attenuated vaccines during the study period.
- •Major surgery within 4 weeks prior to the first dose, anticipation of major surgery (other than surgery for diagnostic purposes) during the study period, or diagnostic or low-invasive surgery within 7 days prior to the first dose (excluded for puncture biopsies).
- •Adverse effects of prior antitumor therapy have not recovered to CTCAE version 5.0 grade rating ≤
- •Patients who have received a previous allogeneic bone marrow/hematopoietic stem cell transplant or solid organ transplant.
- •Pregnant and lactating women.
- •Subjects who in the judgment of the investigator, have a history of other serious systemic disease or are unfit to participate in this trial for any other reason.
研究组 & 干预措施
LTC004+Toripalimab
Experimental
Eligible subjects will receive LTC004 on day 1 of Week 1 and day 1 of week 3. Beginning at week 5, all subjects will receive LTC004 in combination with Toripalimab.
干预措施: LTC004+Toripalimab (Drug)
结局指标
主要结局
ORR
时间窗: up to 12 months
Antitumor efficacy of LTC004+Toripalimab treated patient with advanced solid tumors resistant to first-line immunotherapy
次要结局
- PFS(up to 12 months)
- DCR(up to 12 months)
- DOR(up to 12 months)
- OS(up to 12 months)
研究者
研究点 (1)
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