NCT06445517招募中1 期
A Phase 1, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ISM8207 Monotherapy in Patients With Advanced Solid Tumors or Relapsed/Refractory B-Lymphoid 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
- 60
- 试验地点
- 4
- 主要终点
- Incidence of dose-limiting toxicity (DLT) events
研究概览
简要总结
The goal of this clinical trial is to study ISM8207 in participants with advanced solid tumors and relapsed/refractory B-cell lymphoma. The primary objective is to evaluate the safety and tolerability of ISM8207 orally administered in participants with advanced solid tumors and relapsed/refractory B-cell lymphoma
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants with age ≥18 years at the time of signing the informed consent.
- •Advanced solid tumors: Histologically confirmed advanced or metastatic solid tumors who have disease progression after standard therapy, intolerable to standard therapy, or for whom no standard therapy exists.
- •B-cell lymphoma: Histologically confirmed B-cell lymphoma who had received at least one prior line of standard therapy and were relapsed after or refractory to the standard therapy.
- •Have measurable or evaluable lesions in Part 1 and at least one measurable target lesion in Part 2 as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or Lugano
- •ECOG PS (Eastern Cooperative Oncology Group Performance Status)≤
- •Life expectancy of ≥12 weeks as judged by the investigator.
- •Adequate organ function as determined by medical assessment.
- •Capable of providing signed ICF and complying with the requirements and restrictions listed in the ICF and in this study protocol.
- •Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception during the treatment period and for 90 days after the last dose of ISM8207.
排除标准
- •Prior treated with other QPCTL, CD47 or SIRPα inhibitors.
- •Burkitt lymphoma/leukemia, plasma cell myeloma, plasmablastic lymphoma.
- •Participation in other therapeutic clinical studies within 28 days or 5 half- lives (whichever is shorter) prior to first dose of study treatment.
- •Anti-tumor therapy (chemotherapy, immunotherapy, targeted therapy, biologic therapy, or other anti-tumor therapy) within 28 days or 5 half-lives, whichever is shorter prior to first dose of study treatment.
- •Previous allogeneic stem cell transplantation or autologous stem cell. transplantation within 3 months prior to first receiving study treatment.
- •Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding alopecia).
- •Received antitumor steroid therapy within 7 days prior to the first study treatment administration.
- •A serious illness or medical condition(s)
研究组 & 干预措施
Dose Escalation: ISM8207
Experimental
Participants will receive ISM8207 orally once on day 1 during single dose period (3 days) then once daily in repeated 28-day cycles from Cycle 1 onwards.
干预措施: ISM8207 (Drug)
Dose Expansion: ISM8207
Experimental
Participants will receive ISM8207 orally once daily in repeated 28-day cycles.
干预措施: ISM8207 (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicity (DLT) events
时间窗: 31 days
Incidence and severity of adverse events (AEs)
时间窗: Approximately 2 years
Recommended phase 2 dose (RP2D)
时间窗: 31 days
次要结局
- terminal half-life (t1/2)(Approximately 2 years)
- apparent volume of distribution (Vz/F)(Approximately 2 years)
- average concentration at steady state (Css,av)(Approximately 2 years)
- time of Css,max (Tss,max)(Approximately 2 years)
- best objective response (BOR)(Approximately 2 years)
- 6-month overall survival (OS) rates(Approximately 2 years)
- maximum observed concentration (Cmax)(Approximately 2 years)
- duration of response (DoR)(Approximately 2 years)
- disease control rate (DCR)(Approximately 2 years)
- maximum observed concentration at steady state (Css,max)(Approximately 2 years)
- CLss/Fss(Approximately 2 years)
- accumulation ratio of Cmax (RCmax) after multiple doses(Approximately 2 years)
- area under the concentration-time curve (AUC)(Approximately 2 years)
- apparent clearance (CL/F)(Approximately 2 years)
- minimum observed concentration at steady state (Css,min)(Approximately 2 years)
- AUC from time 0 to time dosing interval (AUCss,0-tau)(Approximately 2 years)
- accumulation ratio of AUC (RAUC) after multiple doses(Approximately 2 years)
- objective response rate (ORR)(Approximately 2 years)
- progression-free survival (PFS)(Approximately 2 years)
- 1-year overall survival (OS) rates(Approximately 2 years)
- time of maximum observed concentration (Tmax)(Approximately 2 years)
- Vz/Fss(Approximately 2 years)
研究者
研究点 (4)
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