NCT06484816招募中1 期
A Dose Escalation and Expansion Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-1942 in Patients with Advanced Solid Tumor And/or Relapsed/Refractory Hematologic Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Adverse events/serious adverse events
研究概览
简要总结
A phase I study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TGRX-1942 in patients with advanced solid tumor and/or relapsed or refractory hematological malignancies
详细描述
This study is designed as a three-part study, with dose escalation, dose expansion and indication expansion phases. Patients with advanced solid tumors will be initially enrolled to the study. Other indications including solid tumors with specific gene mutations, or other hematological malignancies with be considered for expansion phases, with appropriate doses as evaluated at the end of dose escalation phase.
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
- •For dose escalation phase, patient is diagnosed with advanced/metastatic solid tumor who had failed standard therapies and does not have available effective treatment, or who relapsed from prior treatments
- •ECOG score of equals to or lower than 1
- •Life expectancy of at least 3 months
- •Adequate systemic and organ functions, including hematologic, hepatic and kidney functions
- •Willing to provide available tumor biopsy sample or reports, or willing to undergo tumor biopsy examination, and willing to partake whole blood sampling for evaluations
- •For female of child-bearing potential, willing to undergo plasma pregnancy test 28 days before first dose and have negative results
- •Male and Female of child-bearing potential must agree to take effective contraceptive measures during the entire treatment period and for 2 months after the end of treatment
- •Understand and willing to sign informed concent; willing and able to complete the visiting schedule and other tasks as required for the study
排除标准
- •Allergic to any of the ingredient of the investigational drug
- •History of other primary malignancies
- •Have adverse/toxic effects from previous treatment that has not recovered to CTCAE 5.0 <= Grade 1
- •Received other anti-tumor treatments (i.e., chemotherapy, biologics, immunotherapy, targeted therapy, etc.) 28 days before first dose, or radiation therapy 14 days before first dose
- •Used drugs known to significantly affect P450 metabolism 2 weeks before first dose
- •Participated in other clinical trials and used other investigational agents 28 days before first dose
- •Received major surgeries or had traumatic injuries 28 days before first dose
- •Need to use concomitant drugs that could cause QTc elongation or induce Torsades de Pointes
- •History or presence of other medical conditions, such as HIV/HBV/HCV positive; received anticoagulation treatment; coagulation dysfunction; major or clinically significant cardiovascular disease; pneumonia; clinically significant gastrointestinal abnormalities that could affect drug absorption; uncontrollable hypertension; ulcer in abdomen, intestine, stomach, trachea or esophagus; uncontrolled seizure or have other central nervous system diseases, poorly managed diabetes; long QT syndrome; uncontrolled active infections; uncontrolled pericardial or abdominal effusion; adrenaline malfunction; thyroid dysfunction; severe unhealed wound, ulcer or bone fractures; Toxic epidermal necrolysis; Stevens-Johnson syndrome
- •Have symptomatic or uncontrolled primary or metastatic central nervous system tumor or Leptomeninges tumor, or untreated diseases that cause compressions to spinal cords
- •For female patients: in pregnancy or breast-feeding periods
- •Presence of any condition or history that could affect study results or participation to the study in the judgement of the investigator
- •Used immunosuppressant drugs within14 days before first dose
- •Received vaccine injection within 30 days of Cycle 1 Day 1
研究组 & 干预措施
Experimental: TGRX-1942
Experimental
Patients will be given one of the doses of 4mg, 10mg, 20mg, 30mg, 40mg, 50mg, or 60mg orally once a day
干预措施: TGRX-1942 (Drug)
结局指标
主要结局
Adverse events/serious adverse events
时间窗: From screening through completion of the study, an average of 3.5 years.
to record and analyse the occasions and rates of subjects with adverse events (AEs) and serious adverse events (SAEs) to understand drug safety profile
Maximum Tolerated Dose (MTD)
时间窗: From Day 1 of Cycle 1 to Day 28 of Cycle 1 of dose escalation phase (each cycle is 28 days)
MTD is defined as the dose level with dose-limiting toxicity (DLT) rate of greater than 0.322 as calculated using the BOIN design at dose escalation phase.
次要结局
- Preliminary efficacy(From screening, every 3 cycles during treatment period (each cycle is 28 days) and at end of study, an average of 3.5 years.)
- Maximum Concentration (Cmax)(On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase)
- Time to Maximum Concentration (Tmax)(On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase)
- Area Under Curve (AUC0-t)(On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase)
- Steady State Trough Concentration (Ctrough,ss)(On Day 1, 8, 15 and 22 of Cycle 1 and Day 1 of every 3 cycles (each cycle is 28 days). Average duration of the treatment period is 3 years.)
- Steady State Area Under Curve (AUC0-t,ss)(On Day 1, 8, 15 and 22 of Cycle 1 and Day 1 of every 3 cycles (each cycle is 28 days). Average duration of the treatment period is 3 years.)
- Steady State Time to Maximal Concentration (Tmax,ss)(On day 1 of Cycle 1 of dose escalation phase (each cycle is 28 days))
- Half life (T1/2)(On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase)
- Apparent Volume of Distribution (Vz/F)(On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase)
- Apparent Clearance (CL/F)(On day 1-6 of the single dosing phase; patient will only be dosed once on Day 1 of this phase)
- Steady State Maximal Concentration (Cmax,ss)(On Day 1, 8, 15 and 22 of Cycle 1 and Day 1 of every 3 cycles (each cycle is 28 days). Average duration of the treatment period is 3 years.)
研究者
研究点 (1)
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