Ignite Creation Date:
2024-05-06 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05262491
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2022-02-21
Brief Title:
A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor
Sponsor:
Sichuan Baili Pharmaceutical Co Ltd
Organization:
Sichuan Baili Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase I Clinical Study to Evaluate the Safety Tolerability Pharmacokinetic Characteristics and Preliminary Efficacy of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor
Status:
RECRUITING
Status Verified Date:
2024-09
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:
In phase Ia study the safety and tolerability of BL-B01D1 in patients with locally advanced or metastatic gastrointestinal tumor and other solid tumor will be investigated to determine the dose-limiting toxicity DLT maximum tolerated dose MTD of BL-B01D1
In phase Ib study the safety and tolerability of BL-B01D1 at the phase Ia recommended dose will be further investigated and recommended phase II dose RP2D for phase II clinical studies will be determined
In addition the preliminary efficacy pharmacokinetic characteristics and immunogenicity of BL-B01D1 in patients with locally advanced or metastatic gastrointestinal tumor and other solid tumor will be evaluated
In phase Ib study the safety and tolerability of BL-B01D1 at the phase Ia recommended dose will be further investigated and recommended phase II dose RP2D for phase II clinical studies will be determined
In addition the preliminary efficacy pharmacokinetic characteristics and immunogenicity of BL-B01D1 in patients with locally advanced or metastatic gastrointestinal tumor and other solid tumor will be evaluated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None