NCT06596915招募中1 期
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy of BA1302 in Patients With Advanced Solid 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
- 167
- 试验地点
- 1
- 主要终点
- Number of participants with dose limiting toxicities
研究概览
简要总结
This is a first-in-human (FIH), multicenter, open-label Phase I study to evaluate the safety, tolerability, PK profile, immunogenicity, and preliminary efficacy of BA1302 in patients with advanced solid malignancies. The study includes a dose-escalation phase (Part A) and a dose-expansion phase (Part B).
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
- •Metastatic or unresectable solid malignancy that is histologically or cytologically confirmed. Patients who have progressed on or after standard therapy, or are intolerant of standard therapy, or have no appropriate standard therapy available.
- •Part A: Advanced malignant solid tumors;
- •Part B: Metastatic melanoma, Advanced breast cancer, Advanced Non-small cell lung cancer (NSCLC), Advanced pancreatic adenocarcinoma.
- •2.Participants should be able to provide adequate tumor tissue for biomarker analysis
- •3.ECOG Performance Status ≤
- •4.Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1)
排除标准
- •Malignant disease within 5 years prior to the first dose of investigational drug other than that being treated in this study. Except completely resected basal cell carcinoma, cutaneous squamous cell skin carcinoma and papillary thyroid carcinoma and completely resected carcinoma in situ of any type.
- •Received any chemotherapy, radiotherapy, targeted therapy, cell therapy, immunotherapy, ADC medication or other anti-cancer treatment within 28 days prior to the first dose.
- •3.History of severe hypersensitivity reactions to any ingredient of study drugs.
- •4.Pregnant or lactating women.
- •5.Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results.
研究组 & 干预措施
BA1302
Experimental
干预措施: BA1302 (Drug)
结局指标
主要结局
Number of participants with dose limiting toxicities
时间窗: Up to 21 days
adverse events
时间窗: Through 28 days after the last study treatment
次要结局
- Area under the concentration-time curve (AUC) from time zero to the last quantifiable concentration (AUC0-t)(Up to approximately 1 years)
- AUC from time zero to infinity (AUC0-inf)(Up to approximately 1 years)
- Area under the concentration-time curve (AUC) at steady state(Up to approximately 1 years)
- Maximum serum concentration (Cmax)(Up to approximately 1 years)
- Elimination half-life (t1/2)(Up to approximately 1 years)
- Incidence of anti-drug antibodies (ADA)(Up to approximately 1 years)
- Objective response rate (ORR)(Up to approximately 1 years)
- Duration of objective response (DOR)(Up to approximately 1 years)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
A Study to Evaluate ANS014004 in Subjects With Locally Advanced or Metastatic Solid TumorsLocally Advanced or Metastatic Solid TumorsNCT06328439Avistone Biotechnology Co., Ltd.40
已完成
1 期
A Phase 1 Study of Fisogatinib (BLU-554) in Patients With Hepatocellular CarcinomaHepatocellular Carcinoma (HCC)NCT02508467Blueprint Medicines Corporation146
招募中
1 期
A Study to Investigate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy With GenSci122 in Participants With Advanced Solid TumorsAdvanced Solid TumorNCT06772415Changchun GeneScience Pharmaceutical Co., Ltd.163
招募中
1 期
A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid TumorsLocally Advanced or Metastatic Solid TumorsNCT06307795Avistone Biotechnology Co., Ltd.63
进行中（未招募）
1 期
A Study of APS03118 in Advanced Solid Tumors Harboring RET Mutations or FusionsRET-altered Solid TumorsNCT05653869Applied Pharmaceutical Science, Inc.108