NCT05219578终止1 期
A Phase 1/2 Study of RTX-224 for the Treatment of Patients With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 5
- 主要终点
- Safety Assessment by rate of Adverse Events (AEs)
研究概览
简要总结
This is an open-label, multidose, first-in-human (FIH), Phase 1/2 study of RTX-224 for the treatment of patients with relapsed or refractory (R/R), or locally advanced solid tumors.
详细描述
This is a Phase 1, open label, multicenter, multidose, first-in-human (FIH), dose escalation and expansion to determine the safety and tolerability, recommended phase 2 dose, and pharmacology, and antitumor activity of RTX-224 in adult patients with persistent, recurrent, or metastatic, unresectable solid tumors. The study will include a monotherapy dose escalation phase followed by an expansion phase.
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
- •Signed written informed consent obtained prior to study procedures Patients ≥18 years with an ECOG of 0 or 1
- •R/R, or locally advanced, unresectable, and histologically or cytologically confirmed
- •(a) NSCLC, (b) cutaneous melanoma, (c) HNSCC, (d) UC, or (e) TNBC, which are refractory to or otherwise ineligible for treatment with standard-of-care treatments
- •Prior therapy in each disease setting must include the following:
- •NSCLC: Patients must have experienced disease progression following platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor. Patients with EGFR, ALK, ROS-1, or other actionable mutations should have previously received or been ineligible for therapies targeting their respective mutation(s).
- •Cutaneous melanoma: Patients must have experienced disease progression following a PD-1 or PD-L1 inhibitor. Patients with V600E mutations should have previously received or been ineligible for approved BRAF inhibitor or MEK inhibitor therapy.
- •HNSCC: Patients must have experienced disease progression following platinum-based combination chemotherapy and a PD-1 or PD-L1 inhibitor.
- •UC: Patients must have experienced disease progression following platinum-based combination chemotherapy and a PD-1 or PD-L1 inhibitor.
- •TNBC: Patients must have experienced disease progression following single-agent or combination chemotherapy. Patients with BRCA1/2 mutations should have previously received or been ineligible for an approved PARP inhibitor; patients who are PD-L1 positive should have received or been ineligible for an approved PD-1 or PD-L1 inhibitor.
- •Disease must be measurable per Response Evaluation Criteria
- •The shorter of 28 days or 5 half-lives must have elapsed since the completion of prior therapy, before initiation of study treatment.
- •Adequate Organ Function as Defined by the protocol:
- •AST and ALT ≤3 × the upper limit of normal (ULN) Except in documented cases of Gilbert syndrome, total bilirubin ≤1.5 × ULN
- •Serum albumin ≥2.5 g/dL
- •Serum or plasma creatinine ≤1.5 × ULN and/or glomerular filtration rate ≥50 mL/min/1.73 calculated by the Cockcroft-Gault formula
- •Absolute neutrophil count ≥1 × 103/μL
- •Platelet count ≥100 × 103/μL
- •Hemoglobin ≥9 g/dL
排除标准
- •Patient has central nervous system (CNS) involvement. If the patient fulfills the following 3 criteria, she/he is eligible for the trial after consultation with the Sponsor Medical Monitor.
- •Completed prior therapy for CNS metastases (radiation and/or surgery)
- •CNS tumor(s) is clinically stable at the time of enrollment
- •Patient does not require corticosteroid or antiepileptic therapy for management of CNS metastases
- •Known hypersensitivity to any component of study treatment or excipients.
- •Positive antibody screen using institution's standard type and screen test.
- •Clinically significant, active and uncontrolled infection, including human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
研究组 & 干预措施
RTX-224 Dose Escalation
Experimental
Phase 1: RTX-224 monotherapy dose escalation in Solid Tumors, administered intravenously on Day 1 of each cycle.
干预措施: RTX-224 (Drug)
RTX-224 Dose Expansion
Experimental
Phase 2: RTX-224 monotherapy dose expansion in Solid Tumors, administered intravenously on Day 1 of each cycle.
干预措施: RTX-224 (Drug)
结局指标
主要结局
Safety Assessment by rate of Adverse Events (AEs)
时间窗: up to 30 months
Measured by incidence of Treatment Emergent Adverse Events (TEAEs)
Dose limiting toxicities (DLTs) of RTX-224
时间窗: up to 30 months
As determined by incidence and severity of adverse events
次要结局
- Pharmacodynamics (PD) of RTX-224(up to 30 months)
- Pharmacokinetics (PK) of RTX-224(up to 30 months)
- Anti-tumor activity of RTX-224(up to 30 months)
研究者
研究点 (5)
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