Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05880706
Status:
RECRUITING
Last Update Posted:
2023-08-31
First Post:
2023-05-17
Brief Title:
A Study of BL-B01D1 and BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
Sponsor:
Sichuan Baili Pharmaceutical Co Ltd
Organization:
Sichuan Baili Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 for Injection and BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
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 Phase II clinical study to evaluate the efficacy and safety of BL-B01D1 for injection and BL-B01D1 in combination with Osimertinib Mesylate Tablets in patients with locally advanced or metastatic non-small cell lung cancer
Detailed Description:
Objective To evaluate the safety tolerability and efficacy of BL-B01D1 in combination with Osimertinib Mesylate Tablets in patients with locally advanced or metastatic non-small cell lung cancer NSCLC with EGFR-sensitive mutations and to further explore the optimal dose and mode of combination Secondary objective To evaluate the PK immunogenicity and drug-drug interaction DDI of the investigational drug BL-B01D1 Exploratory objective To explore potential predictive prognostic biomarkers in relation to study drug therapy responses including levels of biomarkers including but not limited to EGFR HER3 etc in archived andor fresh tumor tissue and blood samples obtained before andor after study therapy completion andor at the time of disease progression
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