A Study of MHB009C in Patients With Advanced Solid Tumors

Официальное название

A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB009C for Injection in Patients With Advanced Solid Tumors

Обзор

This is a first-in-human, open-label, multicenter Phase I/II study of MHB009C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB009C monotherapy.

Подробное описание

This first-in-human clinical trial of MHB009C 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 MHB009C 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 MHB009C monotherapy in patients with specific types of advanced solid tumors.

Вмешательства

• Препарат MHB009C for Injection
  IV administration of MHB009C Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

Первичные конечные точки

• (Dose-Escalation Stage): Dose-Limiting Toxicity (DLT) and Maximum tolerated dose (MTD) for MHB009C [Срок оценки: Up to day 21 from the first dose.]
• (Dose-Expansion Stage): Objective tumor response (ORR) determined by investigators according to RECIST v1.1 [Срок оценки: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years]

Вторичные конечные точки (7)

• Duration of response (DOR) determined by investigators according to RECIST v1.1 [Срок оценки: 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 [Срок оценки: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years]
• Overall survival (OS) [Срок оценки: 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 [Срок оценки: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years.]
• Area Under the Concentration-Time Curve (AUC) [Срок оценки: From pre-dose to 22 days after the first dose.]
• Maximum Plasma Concentration (Cmax) [Срок оценки: From pre-dose to 22 days after the first dose.]
• Proportion of subjects who develop anti-MHB009C antibodies (ADA). [Срок оценки: From pre-dose to 30 days post end of treatment.]

Критерии участия

Критерии включения

• 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 0-1.
• 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. -

Критерии исключения

• 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 1.
• 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. -

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fudan University Shanghai Cancer Center, Shanghai — Шанхай

Идентификаторы

NCT: NCT07326488 · MHB009C-A-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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