A Phase 1/2 Trial of RPTR-1-201, a T Cell Receptor Bispecific Therapy, in Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of participants with dose-limiting toxicities and treatment-emergent adverse events.
研究概览
简要总结
This is an early phase trial designed to evaluate the safety, tolerability, and preliminary antitumor activity of RPTR-1-201 in adults with advanced solid tumors. The trial includes dose escalation and dose expansion parts and will evaluate RPTR-1-201 as monotherapy and in combination with an anti-PD-1 monoclonal antibody.
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
- Single (Outcomes Assessor)
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
- •Histologically or cytologically confirmed locally advanced or metastatic solid tumors that is not amenable to curative treatment.
- •At least one measurable lesion per RECIST v1.1 as assessed by the investigator.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Adequate organ function as defined in the trial protocol.
- •Ability to provide written informed consent and comply with trial procedures.
排除标准
- •History of another malignancy within 3 years before the first dose of trial intervention, with the exception of malignancies considered cured and not expected to require active therapy (for example, certain skin cancers or in situ malignancies) per protocol.
- •Known active leptomeningeal disease or uncontrolled central nervous system metastases.
- •Active, clinically significant, autoimmune diseases requiring systemic immunosuppressive therapy.
- •Prior allogenic organ transplantation
- •Clinically significant uncontrolled medical or psychiatric condition, that in the opinion of the investigator, would increase risk or interfere with trial participation.
- •Other protocol-defined inclusion and exclusion criteria apply
研究组 & 干预措施
Monotherapy
Participants receive RPTR-1-201 at doses and schedules defined by the trial protocol.
干预措施: RPTR-1-201 (Drug)
Combination
Participants receive RPTR-1-201 in combination with an approved or investigational PD-1 monoclonal antibody at doses and schedules defined by the trial protocol.
干预措施: RPTR-1-201 (Drug)
Combination
Participants receive RPTR-1-201 in combination with an approved or investigational PD-1 monoclonal antibody at doses and schedules defined by the trial protocol.
干预措施: PD-1 / PD-L1 monoclonal antibody (Drug)
结局指标
主要结局
Number of participants with dose-limiting toxicities and treatment-emergent adverse events.
时间窗: From first dose through 30 days after last dose of trial treatment.
Number of participants experiencing dose-limiting toxicities and treatment-emergent adverse events, including events considered related to RPTR-1-201, graded according to CTCAE v5.0.
Objective Response Rate (ORR) per RECIST v1.1
时间窗: From first dose until end of treatment or documented disease progression, whichever occurs first (assessed up to 24 months).
Proportion of participants with a best overall response of complete response or partial response per RECIST v1.1, as assessed by the investigator.
次要结局
- Incidence and severity of adverse events and abnormal safety assessments.(From first dose through 30 days after last dose of trial treatment)
- Pharmacokinetics of RPTR-1-201(First dose until end of treatment (assessed up to 24 months).)
- Progression Free Survival (PFS)(From first dose until disease progression, death, or end of trial follow-up, whichever occurs first (assessed up to 24 months).)
- Overall survival (OS)(From first dose until death from any cause or end of trial follow-up, whichever occurs first (assessed up to 36 months).)
- Time to Response(From first dose until first documented response, disease progression, or end of trial follow-up, whichever occurs first (assessed up to 24 months).)
- Pharmacokinetics of RPTR-1-201 (AUC)(First dose until end of treatment (assessed up to 24 months))
- Immunogenicity of RPTR-1-201(First dose until end of treatment (assessed up to 24 months))