Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-27 @ 8:46 AM
Study NCT ID:
NCT06368960
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BM201 in Combination With Radiotherapy in Patients With Advanced Solid Tumors
Sponsor:
InnoBM Pharmaceuticals Co., Ltd.
Organization:
Study Overview
Official Title:
The Study to Evaluate the Safety, PK, and Preliminary Efficacy of BM201 Injection Combined With Radiotherapy in Patients With Unresectable Locally Advanced or Metastatic Solid Tumors That Failed Standard Therapy
Status:
RECRUITING
Status Verified Date:
2024-04
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:
BM201-1001
Brief Summary:
This is a non-randomized，open-label，controlled multi-center Phase Ⅰ study to evaluate tolerability, pharmacokinetics, and preliminary efficacy of BM201 injection in combination with radiotherapy in patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors who have failed standard therapy or are unable to receive standard treatment.
Detailed Description:
This is a Phase I, open-label clinical study primarily designed to evaluate the safety and tolerability of BM201 injection in combination with radiotherapy in patients with advanced solid tumors.
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 |
|---|---|---|---|---|
| CTR20223162 | REGISTRY | National Medical Products Administration | View |