NCT07460375招募中1 期
A First-in-Human Phase 1/2, Dose Escalation and Dose Expansion Study to Evaluate Safety, Tolerability, and Preliminary Efficacy of Claudin18.2 (CLDN18.2)-Directed Antibody-Drug Conjugate (ADC) LCB02A in Patients With CLDN18.2-positive Advanced Solid Tumors
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 191
- 试验地点
- 8
- 主要终点
- Safety of LCB02A (Phase 1 and 2)
研究概览
简要总结
This is a Phase 1/2 open label study consisting of dose escalation cohorts (Phase 1) followed by expansion cohorts (Phase 2). The Phase 1 dose escalation population includes subjects with advanced solid tumors that are refractory to standard of care therapy or for whom no standard of care options are available. Once the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of single agent LCB02A is determined, the study will proceed to Phase 2 expansion cohorts in selected tumor types.
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
- •Phase 1 Dose Escalation: histologically or cytologically confirmed advanced solid tumors that are Claudin 18.2 positive and refractory to standard of care treatment.
- •Phase 2 Dose Expansion: selected histologically or cytologically confirmed advanced solid tumors that are Claudin 18.2 positive and refractory to standard of care treatment. Expansion cohort indications will be prioritized based on data from the Phase 1 dose escalation portion.
- •Prior treatment with Claudin 18.2 directed therapy is permitted.
- •Measurable disease as defined by RECIST v1.1
- •Willingness to provide archival tumor tissue when available, or to undergo a pre-treatment biopsy if archival tissue is not available.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Adequate organ function as defined by:
- •Absolute neutrophil count ≥ 1.5 × 109/L , without colony stimulating factor support for the past 14 days
- •Platelet count ≥ 100 × 109/L
- •Hemoglobin level ≥ 9.0 g/dL
- •Total bilirubin ≤ 1.5× upper limit of normal (ULN) or <3 x ULN with Gilbert's syndrome or liver metastases at baseline
- •Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5× ULN (≤ 5.0× ULN for subjects with liver metastases)
- •Albumin ≥ 2.5 g/dL
- •Creatinine clearance ≥ 60 mL/min
排除标准
- •Prior exposure to ADCs with a Topo1 inhibitor payload.
- •Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Note: Patients may be considered for enrollment if they have previously treated brain metastases that are clinically stable or radiologically stable for at least 14 days prior to the first dose.
- •Received radiotherapy within 21 days prior to the first dose of study drug. Note: For palliative radiotherapy for symptomatic improvement of non-central nervous system (CNS) lesions (total duration of radiotherapy ≤ 14 days), a radiation washout period of 7 days is required prior to the first dose.
- •Any medical conditions that may confound the study results, interfere with the patient's compliance, or impair the interests of the subject, as assessed by the Investigator.
研究组 & 干预措施
LCB02A monotherapy
Experimental
干预措施: LCB02A (Drug)
结局指标
主要结局
Safety of LCB02A (Phase 1 and 2)
时间窗: Up to 48 months
Incidence and severity of AEs
Recommended Phase 2 dose of LCB02A (Phase 1)
时间窗: Up to 24 months
Based on tolerability, preliminary anti-tumor activity, and pharmacokinetics
Objective response rate (Phase 2)
时间窗: Up to 24 months
Assessed by RECIST 1.1
次要结局
- Duration of Response (Phase 1 and 2)(Up to 48 months)
- Plasma concentrations of LCB02A (Phase 1 and 2)(Up to 48 months)
- Disease control rate (Phase 1 and Phase 2)(Up to 48 months)
- Progression Free Survival (Phase 1 and Phase 2)(Up to 48 months)
- Overall Survival (Phase 1 and Phase 2)(Up to 48 months)
研究者
研究点 (8)
Loading locations...
相似试验
招募中
1 期
AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid TumorsColorectal CancerNCT07454642Avacta Life Sciences Ltd174
招募中
1 期
First in Human Multicenter Open Name Dose-increase,Consolidation method to Study Safety drug-level in Blood & drug metabolism Clinical Activity of Oral JBI-778 in Lung Cancer Patients with, without Brain Metastasis IDH Mutated WHO Grade 3,4 Recurrent Glioma, Salivary glands tumorCTRI/2024/07/070802Jubilant Therapeutics India Limited42
招募中
1 期
A Phase 1 Study of D3S-003 as Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation.NCT07456046D3 Bio (Wuxi) Co., Ltd42
招募中
1 期
CD64 CAR T Cell Therapy in Adults With Relapsed and/or Refractory AMLMyelodysplastic SyndromeNCT07347418University of Colorado, Denver23
招募中
2 期
A first-in-human, dose escalation and dose expansion study of SAR445877 in adult participants with advanced solid tumors2023-507141-28-00Sanofi-Aventis Recherche & Developpement115