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

Chengdu Syncor Pharmaceutical Co., Ltd.

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Metastatic Solid Tumors

Treatments: Drug: BPR-6023021 for injection

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07249892

BPR-6023021-101

CTR20254494 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 195 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. The age should be up to 18 years at the time of signing the informed consent form (ICF);
2. The Eastern Cooperative Oncology Group (ECOG) performance status score should be ≤ 1;
3. The expected survival period should be ≥ 3 months
4. 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
5. Before the first administration, a 99mTc-MDP bone scan diagnosed multiple bone metastases, and at least two site was confirmed by CT or MRI;
6. Have adequate organ and bone marrow functions;
7. For subjects with reproductive capacity, take effective medical contraceptive measures during the study treatment and within 6 months after the last administration;
8. 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

1. The washout period before the first administration of the study drug was insufficient.
2. Previous received similar radionuclide internal irradiation treatment.
3. Previous received or planned to receive during the study period semi-body external radiotherapy targeting bone metastases.
4. Known "super bone imaging".
5. Known spinal cord compression, or clinical imaging manifestations suggesting impending spinal cord compression.
6. Any cardiovascular or cerebrovascular diseases or cardiovascular risk factors that may affect the treatment of the study drug.
7. Poorly controlled diabetes and hypertension.
8. 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.
9. Had other malignant tumors within 5 years before the first administration.
10. Subjects with severe and/or uncontrolled concomitant diseases.
11. Active hepatitis B or active hepatitis C.
12. Human immunodeficiency virus (HIV) test positive or having a history of acquired immune deficiency syndrome (AIDS); known active syphilis infection.
13. 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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195 participants in 2 patient groups

Phase 1:Dose escalation

Experimental group

Description:

5 dose levels of BPR-6023021 are tentatively planned for Phase 1

Treatment:

Drug: BPR-6023021 for injection

Phase 2: RP2D Cohort

Experimental group

Description:

Participants will receive BPR-6023021 for injection at the Recommended Phase 2 Dose (RP2D) determined from the Phase 1 dose escalation study.The dose of BPR-6023021 for injection in Phase 2 is selected based on the Phase 1 monotherapy dose escalation study.

Treatment:

Drug: BPR-6023021 for injection