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

Official title

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.

Overview

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

Detailed description

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.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (4)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Sun Yat-sen University Cancer Center — Guangzhou

Identifiers

NCT: NCT07249892 · BPR-6023021-101 · CTR20254494

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)
• NMPA/CDE CTR20254494 (chinadrugtrials.org.cn platform)

View this study on ClinicalTrials.gov ↗