Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06241898
Status:
RECRUITING
Last Update Posted:
2024-02-05
First Post:
2024-01-28
Brief Title:
A First-in-human of Multiplle Doses of BB-1709 in Subjects With Locally AdvancedMetastatic Solid Tumors
Sponsor:
Bliss Biopharmaceutical Hangzhou Co Ltd
Organization:
Bliss Biopharmaceutical Hangzhou Co Ltd
Study Overview
Official Title:
A Phase I Open Label Multicenter Dose Escalation and Dose Expansion Study to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Antitumor Activity of BB-1709 in Patients With Locally AdvancedMetastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-01
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 goal of this clinical trial is to test in patients with local advancedmetastatic solid tumors the main questions it aims to answer are
to assess the safety and tolerability of BB-1709
to determine the maximum tolerated doseMTD andor the PR2D of BB-1709
to assess the safety and tolerability of BB-1709
to determine the maximum tolerated doseMTD andor the PR2D of BB-1709
Detailed Description:
The study consists of two parts dose-escalation Phase Ia and dose expansion Phase Ib
Phase Ia is a multicenter open-label first time in human clinical trial to assess safety tolerability pharmacokinetics immunogenicity the preliminary anti-tumor activity of BB-1709 and to establish the MTD andor RP2D of BB-1709 in patients with advanced solid tumors
Phase Ib is to explore one or more RP2Ds to further assess safety tolerability pharmacokinetics immunogenicity and preliminary anti-tumor activity of BB-1709 in patients with specific types of solid tumor
Phase Ia is a multicenter open-label first time in human clinical trial to assess safety tolerability pharmacokinetics immunogenicity the preliminary anti-tumor activity of BB-1709 and to establish the MTD andor RP2D of BB-1709 in patients with advanced solid tumors
Phase Ib is to explore one or more RP2Ds to further assess safety tolerability pharmacokinetics immunogenicity and preliminary anti-tumor activity of BB-1709 in patients with specific types of solid tumor
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