A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB042C for Injection in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- (Dose-Escalation Stage): Dose-Limiting Toxicity (DLT) and Maximum tolerated dose (MTD) for MHB042C
研究概览
简要总结
This is a first-in-human, open-label, multicenter Phase I/II study of MHB042C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB042C monotherapy.
详细描述
This first-in-human clinical trial of MHB042C comprises two parts: a dose escalation phase and a dose expansion phase. The dose escalation phase is an open-label, multicenter study including dose escalation and PK expansion cohorts. The primary objectives are to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MHB042C in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD). In this phase, additional patients may be enrolled in the PK expansion part at dose levels that have completed DLT (dose-limiting toxicity) evaluation.
Based on the safety, PK, and preliminary efficacy data from the completed DLT-evaluated dose levels, the sponsor will initiate the dose expansion phase. This phase is an open-label, multicenter, multi-cohort study designed to further evaluate the safety and efficacy of MHB042C monotherapy in patients with specific types of 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily agrees to participate in the study and signs the informed consent form.
- •Age ≥ 18 years, no restriction on gender.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Estimated life expectancy ≥ 3 months.
- •Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.
- •At least one measurable lesion per RECIST v1.1 criteria or one bone.
- •Adequate bone marrow reserve and organ function. -
排除标准
- •History of ≥2 primary malignancies within 5 years prior to informed consent.
- •Received chemotherapy within 3 weeks, radiotherapy within 4 weeks, or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.
- •Medication of other unmarketed investigational drugs or therapies within 4 weeks before the first dose of investigational drug.
- •Brain metastases, bone marrow metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.
- •Severe bone damage caused by bone metastasis of prostate cancer.
- •Has adverse reactions from previous anti-tumor treatment that have not recovered to ≤ CTCAE 5.0 Grade
- •Severe lung disease affecting pulmonary function.
- •Vaccinated within 4 weeks before dosing.
- •Active systemic infection requiring treatment within 7 days before dosing.
- •Serious cardiovascular or cerebrovascular diseases.
- •Uncontrolled third-space effusions not suitable for enrollment.
- •Significant bleeding, bleeding tendency, or non-healing wounds within 1 month before first dose.
- •Known hypersensitivity or delayed allergic reaction to the investigational product or its components.
- •Drug abuse or other medical/psychiatric condition that may interfere with study participation or results.
- •Known alcohol or drug dependence.
- •Pregnant or breastfeeding women, or individuals planning to conceive. -
研究组 & 干预措施
MHB042C (Phase I: Dose escalation)
There are seven escalating dose cohorts.
干预措施: MHB042C for Injection (Drug)
MHB042C (Phase II: Dose expansion)
The recommended dose from the dose-escalation stage and other potential doses will be further explored.
干预措施: MHB042C for Injection (Drug)
结局指标
主要结局
(Dose-Escalation Stage): Dose-Limiting Toxicity (DLT) and Maximum tolerated dose (MTD) for MHB042C
时间窗: Up to day 21 from the first dose for Q3W administration.
To determine the MTD for further evaluation of IV administration of MHB042C monotherapy in subjects with advanced solid tumors.
(Dose-Expansion Stage): Objective tumor response (ORR) determined by investigators according to RECIST v1.1
时间窗: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
To determine the recommended Phase II dose (RP2D) of MHB042C for the treatment of selected patients with advanced solid tumors based on the safety and efficacy results from all enrolled subjects.
次要结局
- Duration of response (DOR) determined by investigators according to RECIST v1.1(Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years)
- Disease control rate (DCR) determined by investigators according to RECIST v1.1(Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years)
- Overall survival (OS)(Baseline up until death up to approximately 5 years)
- Incidence and severity of adverse events (AEs), serious adverse events (SAEs), AEs leading to treatment suspension, discontinuation(Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years.)
- Pharmacokinetic (PK) parameters of total antibody, ADC, and free toxin at various time points(From pre-dose to 22 days after the first dose.)
- Immunogenicity(From pre-dose to 30 days post end of treatment.)