NCT07554196已完成1 期
An Open-Label Phase 1 Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HH-101 as Monotherapy in Patients With Advanced Solid Tumors
Huahui Health1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年1月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs) per Common Terminology Criteria for Adverse Events v6.0 (CTCAE v5.0)
研究概览
简要总结
The goal of this study is to evaluate the safety of HH-101 antibody, administered as monotherapy to participants with advanced solid tumors.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary signing of the written informed consent form;
- •Histologic or cytologic confirmation of advanced solid tumor;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- •Have an estimated life expectancy ≥3 Months, in the judgement of the investigator;
- •Must have at least 1 measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
排除标准
- •History of other malignancies within 5 years prior to the first dose of study drug, except for malignancies that have been cured after treatment, such as thyroid cancer, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the breast.
- •Receipt of the last systemic anti-tumor therapy within 2 weeks prior to the first dose of study drug, including chemotherapy, radiotherapy, targeted therapy, or traditional Chinese herbal medicine or patent Chinese medicines with anti-tumor activity. Patients who received tumor immune checkpoint inhibitor therapy within 4 weeks prior to the first dose of study drug.
- •Adverse reactions from previous treatments that have not recovered to CTCAE v5.0 Grade 1 or lower (except for alopecia and neuropathy, which, in the Investigator's judgment, are long-standing and not expected to recover).
- •Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
- •If female, is pregnant, breastfeeding, or planning to become pregnant.
- •Known hypersensitivity to HH-101 Injection or any of its components. History of severe hypersensitivity reactions to other therapeutic antibody drugs. Known allergy to multiple substances or history of severe allergic diseases.
- •Known interstitial lung disease or non-infectious pneumonitis requiring steroid therapy.
- •Other severe, acute, or chronic medical conditions, psychiatric disorders, or laboratory abnormalities that, in the Investigator's judgment, may increase the risk associated with study participation or may interfere with the interpretation of study results.
研究组 & 干预措施
HH-101 Dose escalation (cohort 1)
Experimental
干预措施: HH-101 (0.3 mg/kg) (Drug)
HH-101 Dose escalation (cohort 4)
Experimental
干预措施: HH-101 (10 mg/kg) (Drug)
HH-101 Dose escalation (cohort 3)
Experimental
干预措施: HH-101 (3 mg/kg ) (Drug)
HH-101 Dose escalation (cohort 2)
Experimental
干预措施: HH-101 (1 mg/kg ) (Drug)
结局指标
主要结局
Incidence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs) per Common Terminology Criteria for Adverse Events v6.0 (CTCAE v5.0)
时间窗: Baseline through safety follow up completion (Up To 24 Months)
It will be assessed by the frequency, severity and nature of AEs, serious adverse event (SAE), changes in vital signs, physical examination, 12-lead ECG, laboratory tests (haematology, blood chemistry, urinalysis, coagulation Function, Thyroid Function Test and etc.), The severity of AEs will be graded by the NCI CTCAE version 5.0 and the AE terms will be coded by the current version of the Medical Dictionary for Regulatory Activities (MedDRA).
次要结局
- Disease control rate (DCR)(Baseline through Measured Progressive Disease (Up To 24 Months))
- Area under the concentration-time curve (AUC)(up to 24 months)
- Maximum observed plasma concentration (Cmax).(up to 24 months)
- Time to reach Cmax (Tmax).(up to 24 months)
- Terminal elimination half-life (t1/2).(up to 24 months)
- Objective response rate (ORR)(Baseline through Measured Progressive Disease (Up To 24 Months))
- Duration of response (DOR)(Baseline through Measured Progressive Disease or death (Up To 24 Months))
- progression-free survival (PFS)(Baseline through Measured Progressive Disease or death (Up To 24 Months))
- overall survival (OS)(Baseline through the date of death from any cause (Up to 24 Months))
研究者
研究点 (1)
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