A Study of BPR-6023021 in Advanced Solid Tumors With Bone Metastases

Официальное название

A Multicenter, Open-label Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Dosimetry and Efficacy of BPR-6023021 in Subjects With Advanced Solid Tumors With Bone Metastases.

Обзор

A multicenter, open-label Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, dosimetry and efficacy of BPR-6023021 in subjects with advanced solid tumors with bone metastases

Подробное описание

This study is a multicenter, open-label Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, dosimetry and efficacy of BPR-6023021 in subjects with advanced solid tumors with bone metastases. The study is divided into two parts: Phase I and Phase II. The Phase I study is the dose escalation phase. The primary objective is to assess the safety and tolerability of a single administration of BPR-6023021 and to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) based on the occurrence of Dose-Limiting Toxicities (DLTs) associated with BPR-6023021 (if the MTD cannot be determined).The Phase II study is the dose expansion phase. The primary objective is to explore the efficacy of BPR-6023021 at a selected dose level.

Вмешательства

• Препарат BPR-6023021 for injection
  BPR-6023021 is a Radionuclide conjugated drugs (RDC) targeting bone.

Первичные конечные точки

• Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 [Срок оценки: Up to 1 year]

Вторичные конечные точки (4)

• Dosimetry，including Maximum plasma concentration (Cmax) of BPR-6023021 [Срок оценки: Through study completion, an average of 2 year]
• Time to Radiographic Bone Progresion (TTRBP) [Срок оценки: Through study completion, an average of 2 year]
• Radiographic progression-free survival (rPFS) [Срок оценки: Through study completion, an average of 2 year]
• Symptomatic skeletal event-free survival (SSE-FS) [Срок оценки: Through study completion, an average of 2 year]

Критерии участия

Критерии включения

• The age should be up to 18 years at the time of signing the informed consent form (ICF);
• The Eastern Cooperative Oncology Group (ECOG) performance status score should be ≤ 1;
• The expected survival period should be ≥ 3 months
• Phase I and phase II: Subjects with advanced solid tumor bone metastases diagnosed by histology or cytology; and the subjects have failed standard treatment, or have no standard treatment, or are intolerant or not applicable to standard treatment
• Before the first administration, a 99mTc-MDP bone scan diagnosed multiple bone metastases, and at least two site was confirmed by CT or MRI;
• Have adequate organ and bone marrow functions;
• For subjects with reproductive capacity, take effective medical contraceptive measures during the study treatment and within 6 months after the last administration;
• The subjects voluntarily join this study, sign the informed consent form, and can comply with the visit and related procedures stipulated in the protocol.

Критерии исключения

• The washout period before the first administration of the study drug was insufficient.
• Previous received similar radionuclide internal irradiation treatment.
• Previous received or planned to receive during the study period semi-body external radiotherapy targeting bone metastases.
• Known "super bone imaging".
• Known spinal cord compression, or clinical imaging manifestations suggesting impending spinal cord compression.
• Any cardiovascular or cerebrovascular diseases or cardiovascular risk factors that may affect the treatment of the study drug.
• Poorly controlled diabetes and hypertension.
• The toxicity of previous anti-tumor treatment before the first administration has not recovered to ≤ 1 grade (evaluated based on NCI-CTCAE v5.0) or has not reached the level specified in the inclusion/exclusion criteria.
• Had other malignant tumors within 5 years before the first administration.
• Subjects with severe and/or uncontrolled concomitant diseases.
• Active hepatitis B or active hepatitis C.
• Human immunodeficiency virus (HIV) test positive or having a history of acquired immune deficiency syndrome (AIDS); known active syphilis infection.
• During the screening process before the first administration, the condition deteriorated rapidly, such as significant changes in the investigator's assessment of physical condition, etc.

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

• Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT07249892 · BPR-6023021-101 · CTR20254494

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)
• NMPA/CDE CTR20254494 (платформа chinadrugtrials.org.cn)

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