Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376136
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-04-17
Brief Title:
A Multicenter Open Clinical Study of Safety Tolerability Pharmacokinetic Profile and Initial Clinical Efficacy of BAT 8010 for Injection Combined With BAT 1006 in the Treatment of Locally Advanced or Metastatic Tumors
Sponsor:
Bio-Thera Solutions
Organization:
Bio-Thera Solutions
Study Overview
Official Title:
An Evaluation of BAT 8010 for Injection in Combination With BAT 1006 in Locally Advanced or Metastatic Entities Safety Tolerability Pharmacokinetic Profile and Initial Clinical Efficacy of the Tumor in Patients Multicenter Open Phase IbIIa Clinical Study
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:
None
Brief Summary:
This study is a multicenter open exploratory Phase IbIIa clinical trial in humans The combination of BAT8010 and BAT1006 was administered in patients with locally advanced or metastatic solid tumorsHER-2 expression including IHC3 IHC2FISH and IHC2FISH- patientsTolerance and PK characteristics to explore the maximum tolerated dose MTD and provide recommendations for subsequent clinical studies Recommended dose RP2D and rational administration regimen and preliminary evaluation of antitumor efficacy There are two main studies In the first stage the 33 dose escalation rule is proposed to explore the safety and tolerance of the drug Sex The second stage selects the appropriate dose and administration according to the preliminary safety and efficacy results of the previous stage The drug regimen and tumor species were expanded to further explore the combination of BAT8010 and BAT1006 for injectionThe safety and clinical effectiveness of drug administration provided the basis for the follow-up clinical study
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