Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05803018
Status:
RECRUITING
Last Update Posted:
2024-01-31
First Post:
2023-03-23
Brief Title:
A Study of BL-B01D1 in Patients With Multiple Solid Tumors Including Recurrent or Metastatic Gynecological Malignancies
Sponsor:
Sichuan Baili Pharmaceutical Co Ltd
Organization:
Sichuan Baili Pharmaceutical Co Ltd
Study Overview
Official Title:
Phase IbII Clinical Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of BL-B01D1 for Injection in Patients With Multiple Solid Tumors Including Recurrent or Metastatic Gynecological Malignancies
Status:
RECRUITING
Status Verified Date:
2024-07
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:
Phase IbII clinical study to evaluate the safety tolerability pharmacokinetics and efficacy of BL-B01D1 for injection in patients with multiple solid tumors including recurrent or metastatic gynecological malignancies
Detailed Description:
Phase Ib To explore the safety and initial efficacy of BL-B01D1 in a variety of solid tumors including recurrent or metastatic gynecological malignancies to further identify RP2D To evaluate the initial efficacy of BL-B01D1 The pharmacokinetic characteristics and immunogenicity of BL-B01D1 were further evaluated Phase II To explore the efficacy of BL-B01D1 as a single agent RP2D in patients with multiple solid tumors such as recurrent or metastatic gynecological malignancies using Phase Ib clinical studies To evaluate the safety and tolerance of BL-B01D1 To evaluate the pharmacokinetic characteristics and immunogenicity of BL-B01D1
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