2025-524010-28-00招募中2 期
A Phase 1/2 Trial of RPTR-1-201, a T Cell Receptor Bispecific Therapy, in Advanced Solid Tumors
Repertoire Immune Medicines Inc.15 个研究点 分布在 4 个国家目标入组 87 人开始时间: 2026年3月2日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 87
- 试验地点
- 15
- 主要终点
- 1. Phase 1: Number of participants with dose-limiting toxicities and treatment-emergent adverse events.
研究概览
简要总结
Phase 1: Evaluate the safety, tolerability, of RPTR-1-201 as monotherapy and in combination with an anti-PD-1 monoclonal antibody. Phase 2: Evaluate preliminary antitumor efficacy of RPTR-1-201 as monotherapy and in combination with an anti-PD-1 monoclonal antibody.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old on day of signing informed consent
- •HLA testing as confirmed by central review
- •Histologically or cytologically confirmed locally advanced or metastatic solid tumors that is not amenable to curative treatment
- •Participants must have documented radiographic or symptomatic disease progression following receipt of prior standard-of-care therapy for advanced/metastatic disease, and must have no available treatment options that, in the judgment of the Investigator, would be expected to confer clinical benefit or survival advantage.
- •Participants must have received limited prior lines of systemic therapy for advanced or metastatic disease. Prior therapies must have included standard -of-care regimens if the participant was eligible to receive them, based on tumor type, molecular status, and clinical practice guidelines at the time of treatment.
- •At least one measurable lesion per RECIST v1.1 as assessed by the investigator.
- •Adequate organ function as defined in the trial protocol
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- •Willing and able to comply with contraceptive guidelines
排除标准
- •Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- •Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence ≤ 14 days after intervention).
- •Participant received systemic anti-cancer therapy or radiotherapy within 2 weeks prior to start of investigational product
- •Participant with a known additional malignancy that is progressing or has required active treatment in the last three years.
- •Participants with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized.
- •Administered a live vaccine ≤ 28 days before first dose of investigational product
- •Concurrent participation in another therapeutic clinical trial
- •Any medical condition, including alcohol or drug abuse or dependence that would, in the Investigator’s or Sponsor’s assessment, prevent the participant’s participation due to safety concerns, compliance with trial procedure or interpretation of results.
研究组 & 干预措施
KEYTRUDA 25 mg/mL concentrate for solution for infusion.
Test
干预措施: KEYTRUDA 25 mg/mL concentrate for solution for infusion. (Drug)
结局指标
主要结局
1. Phase 1: Number of participants with dose-limiting toxicities and treatment-emergent adverse events.
1. Phase 1: Number of participants with dose-limiting toxicities and treatment-emergent adverse events.
2. Phase 2: Objective Response Rate (ORR) per RECIST v1.1
2. Phase 2: Objective Response Rate (ORR) per RECIST v1.1
次要结局
- 1. All Phases: Incidence and severity of adverse events, including immune-related adverse events, and abnormal safety assessments (clinical laboratory tests, ECGs, vital signs)
- 2. Phase1: Characterization of the pharmacokinetic profile of RPTR-1-201 (for example, maximum observed concentration and exposure over time), initial pharmacodynamics, and incidence of anti-drug antibodies
- 3. Phase1: ORR and best overall response (BOR: CR, PR, stable disease [SD], or progressive disease [PD]) by RECIST v1.1 and iRECIST
- 4. Phase 1: Duration of response (DOR) by RECIST v1.1 and iRECIST
- 5. Phase 1: Disease control rate (CR+PR+SD)
- 6. Phase 1 and 2: PFS and TTR by RECIST v1.1 and iRECIST
- 7. Phase 2: Overall survival (OS)
研究者
Clinical Development Contact
Scientific
Repertoire Immune Medicines Inc.
研究点 (15)
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