Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341114
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-03-14
Brief Title:
A Clinical Study Evaluating the Safety Tolerability Pharmacokinetic Characteristics and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors
Sponsor:
Bio-Thera Solutions
Organization:
Bio-Thera Solutions
Study Overview
Official Title:
A Multicenter Open-label Phase Ib-II Clinical Study Evaluating the Safety Tolerability Pharmacokinetic Characteristics and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-03
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:
The study led by Zhejiang Cancer Hospital and sponsored by Bio-Thera Solutions Ltd is an exploratory multicenter open-label phase Ib-II clinical trial evaluating the safety tolerability pharmacokinetic characteristics and preliminary efficacy of the combination of BAT8008 with BAT1308 in patients with advanced solid tumors
This study aims to explore the safety tolerability and pharmacokinetic characteristics of BAT8008 combined with BAT1308 in patients with advanced solid tumors determine the maximum tolerated dose MTD provide recommended doses and reasonable dosing regimens for subsequent clinical studies and preliminarily evaluate the antitumor efficacy
The study is divided into two stages The first stage will use a 33 dose escalation design to explore the safety and tolerability of the investigational drugs In the second stage based on the preliminary safety and efficacy results from the first stage appropriate doses and tumor types will be selected for expansion studies within the safety dose range to further investigate the safety and clinical efficacy of BAT8008BAT1308 and provide evidence for subsequent clinical studies
This study aims to explore the safety tolerability and pharmacokinetic characteristics of BAT8008 combined with BAT1308 in patients with advanced solid tumors determine the maximum tolerated dose MTD provide recommended doses and reasonable dosing regimens for subsequent clinical studies and preliminarily evaluate the antitumor efficacy
The study is divided into two stages The first stage will use a 33 dose escalation design to explore the safety and tolerability of the investigational drugs In the second stage based on the preliminary safety and efficacy results from the first stage appropriate doses and tumor types will be selected for expansion studies within the safety dose range to further investigate the safety and clinical efficacy of BAT8008BAT1308 and provide evidence for subsequent clinical studies
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