NCT07583771尚未招募1 期
A Phase Ⅰ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic and Preliminary Efficacy of CS08399 in Participants With MTAP-deleted Solid Tumors and Lymphoma
Chipscreen Biosciences, Ltd.1 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2026年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 186
- 试验地点
- 1
研究概览
简要总结
This is a phase I, open-label, first-in-human study of CS08399, comprising two phases: dose escalation (including single-dose and multiple-dose) and cohort expansion. The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of CS08399 in participants with MTAP-deleted solid tumors and Lymphoma, and to recommended Phase 2 dose(s) (RP2D) of CS08399 in appropriate tumor(s).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Understand and sign the informed consent form voluntarily.
- •≥18 years old when signing the informed consent, regardless of sex.
- •Histologically or cytologically confirmed locally advanced or metastatic solid tumors, or relapsed/refractory lymphoma, for which standard therapy has failed or is not tolerated, and no further standard therapy is available. Homozygous MTAP or CDKN2A deletion confirmed by tissue or peripheral blood testing.
- •For glioblastoma: at least one measurable intracranial tumor lesion according to the RANO 2.0 criteria. For other solid tumors: at least one measurable lesion according to RECIST v1.1 criteria. For lymphoma: at least one measurable lesion according to Lugano 2014 criteria.
- •For glioblastoma: KPS score ≥
- •For other solid tumors and lymphoma: ECOG performance status of 0 or
- •Adequate organ function.
- •Life expectancy ≥3 months.
- •Able to swallow and retain oral study medication.
排除标准
- •Received any anti-tumor therapy (including but not limited to chemotherapy, targeted therapy, anti angiogenic therapy, immunotherapy, cell therapy, radiotherapy, tumor embolization, etc.) or experimental drugs/devices that have not been approved for marketing within 28 days prior to the first dose or are still within 5 half-lives of such drugs (whichever is shorter).
- •Previously received MAT2A or PRMT5 inhibitors.
- •Underwent major surgery (cranial, thoracic, or abdominal) within 28 days prior to the first dose or have unresolved wounds, ulcers, or fractures.
- •Have unresolved toxicities from previous treatments that have not recovered to CTCAE v5.0 grade ≤
- •History of other primary malignancies within 5 years prior to the first dose.
- •For solid tumors : The presence of active, clinically symptomatic central nervous system metastases or leptomeningeal metastases or spinal cord compression at screening.
- •Primary central nervous system lymphoma or systemic lymphoma with CNS involvement.
- •Evidence of interstitial lung disease, pulmonary fibrosis, or non-infectious pneumonitis requiring treatment on chest imaging at screening.
- •Active infection requiring systemic anti-infective treatment at screening.
- •Received drainage of pleural effusion, ascites, or pericardial effusion within 1 month prior to the first dose or have significant clinical symptoms.
- •Uncontrolled or significant cardiovascular disease.
- •Poorly controlled diabetes.
- •Significant gastrointestinal abnormalities at screening that may affect drug intake, transport, or absorption.
- •History of gastrointestinal perforation, fistula, peptic ulcer, bowel obstruction, or biliary obstruction within 6 months prior to the first dose.
- •Clinically significant hemoptysis or tumor bleeding within 14 days prior to the first dose; significant active bleeding within 2 months prior to the first dose; currently on anticoagulants; high-risk bleeding tendency at screening.
- •Serious thromboembolic events within 6 months prior to the first dose.
- •Active tuberculosis at screening.
- •Active hepatitis B or hepatitis C at screening.HIV infection or syphilis infection at screening.
- •Allergy or hypersensitivity to any component of the trial drug or known excipients, or history of severe allergic diseases.
- •History of organ transplantation or allogeneic hematopoietic stem cell transplantation.
- •History of alcohol abuse or drug abuse.
- •Any psychiatric or cognitive disorder that may limit understanding of informed consent, compliance with the protocol, or participation in the trial.
- •Pregnant or breastfeeding women.
- •Other conditions deemed unsuitable for participation in this trial by the investigator.
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
QLS5212 for Participants With Advanced Solid TumorsNCT07467629Qilu Pharmaceutical Co., Ltd.100
招募中
1 期
KSV01 Injection for the Treatment of Relapsed/Refractory Diffuse Large B-Cell LymphomaDiffuse Large B Cell Lymphoma (DLBCL)NCT07260812TCRx Therapeutics Co.Ltd18
招募中
1 期
A Clinical Trial of P134 Cells in Recurrent GlioblastomaNCT07318818Tasly Pharmaceutical Group Co., Ltd26
招募中
2 期
MK-4280 and Pembrolizumab in Hematologic Malignancies2023-503587-17-00Merck Sharp & Dohme LLC35
尚未招募
1 期
A Phase I Trial of QLS2313 Injection in Relapsed/Refractory Hematological MalignanciesNCT07294300Qilu Pharmaceutical Co., Ltd.124