Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2025-12-25 @ 1:42 PM
Study NCT ID:
NCT07249892
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of BPR-6023021 in Advanced Solid Tumors With Bone Metastases
Sponsor:
Chengdu Syncor Pharmaceutical Co., Ltd.
Organization:
Study Overview
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.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CTR20254494 | REGISTRY | National Medical Products Administration (NMPA) Drug Clinical Trial Registration And Information Publicity Platform | View |