A Phase I Study to Investigate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics(PK) of SCR-6920 Capsule in Patients With Advanced Malignant Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Dose limiting toxicity(DLT)
研究概览
简要总结
A Phase 1, open label, multi center, dose escalation and expansion study will assess the safety, tolerability, PK, and preliminary efficacy of SCR-6920 capsule in participants with advanced malignant tumors. The purpose of the study is to identify the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D), and to confirm the tolerability and preliminary efficacy of SCR-6920 in participants with advanced solid tumors and relapsed/refractory non-Hodgkin lymphoma(NHL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Histologically or cytologically confirmed locally advanced or metastatic solid tumors or histopathologically confirmed NHL
- •Relapsed/refractory solid tumor or relapsed/refractory NHL who have progressed during or after standard therapy or for which treatment is not tolerated, not suitable, not available.
- •At least one evaluable or measurable lesion (as defined in the protocol).
- •ECOG Performance Status 0 or
- •Life expectancy ≥12 weeks.
- •Adequate organ function (as defined in the protocol).
- •Reproductive criteria (as defined in the protocol).
排除标准
- •Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption.
- •Major surgery, systemic anti-cancer therapy or investigational drug(s) within 4 weeks prior to study entry. Radiation therapy within 2 weeks prior to study entry.
- •Adverse reactions from previous anti-tumor therapy have not yet recovered to ≤ grade 1(excluding hair loss, peripheral neurotoxicity caused by chemotherapy have recovered to ≤ grade 2 ).
- •Autologous hematopoietic stem cell transplantation was performed within 9 months prior to the first dose.
- •History of a second malignancy within 2 years (as defined in the protocol).
- •Active uncontrolled or symptomatic lung disease (as defined in the protocol).
- •Intracranial hypertension or active uncontrolled or symptomatic CNS metastases.
- •Known or suspected hypersensitivity to study medications.
- •Known active uncontrolled or symptomatic CNS metastases.
- •The investigator determined that the patient should not participate in the study.
- •Known mental illness or substance abuse that may disrupt therapy.
- •Clinically significant cardiac abnormalities (as defined in the protocol).
- •Gestating or Lactating women.
- •Pleural effusion, pericardial effusion or ascites that need diuretics or draining within 2 weeks prior to first dose.
- •The patient is currently using a drug known to be a strong inhibitor or inducer of CYP3A4.
研究组 & 干预措施
Dose escalation
Participants will receive SCR-6920 capsule orally at escalating doses, till the maximum tolerated dose level is reached, and the recommended phase 2 dose(RP2D) will be determined.
干预措施: SCR-6920 capsule (Drug)
Dose expansion: non small cell lung cancer(NSCLC)
Participants will receive SCR-6920 capsule orally at the recommended phase 2 dose
干预措施: SCR-6920 capsule (Drug)
Dose expansion: NHL
Participants will receive SCR-6920 capsule orally at the recommended phase 2 dose on a continuous basis
干预措施: SCR-6920 capsule (Drug)
Dose expansion: solid tumors
Participants will receive SCR-6920 capsule orally at the recommended phase 2 dose on a continuous basis
干预措施: SCR-6920 capsule (Drug)
结局指标
主要结局
Dose limiting toxicity(DLT)
时间窗: Up to 28 days
DLT will be evaluated within 28 days since first dose. The number of DLTs will be used to determine the maximum tolerated dose (MTD).
Overall Response Rate (ORR)
时间窗: Up to approximately 1 years
Participants with solid tumor: ORR based on RECIST1.1 criteria; Participants with NHL: ORR based on Lugano criteria
次要结局
- Number of participants with clinically significant changes in laboratory parameters, vital signs, electrocardiogram (ECG), physical examination and organ-specific parameters.(Up to approximately 1 years)
- Pharmacokinetic Parameters: Area Under the Curve (AUC)(Up to approximately 1 years)
- Number of participants with any adverse events (AEs), serious adverse events (SAEs), withdrawal due to AEs, dose interruptions and reductions(Up to approximately 1 years)
- Change from Baseline in symmetrical arginine dimethylation (SDMA) as a PD measure(Up to approximately 1 years)
- Pharmacokinetic Parameters: Maximum Concentration (Cmax)(Up to approximately 1 years)
- Pharmacokinetic Parameters: Trough Concentration (Ctrough)(Up to approximately 1 years)
- Pharmacokinetic Parameters: Time to Maximum Concentration (Tmax)(Up to approximately 1 years)
- Pharmacokinetic Parameters: Terminal elimination half life (t1/2)(Up to approximately 1 years)