Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 1:03 AM
Study NCT ID:
NCT05217693
Status:
RECRUITING
Last Update Posted:
2025-07-24
First Post:
2021-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A First-in-human of Multiplle Doses of BB-1705 in Subjects With Locally Advanced/Metastatic Solid Tumors
Sponsor:
Bliss Biopharmaceutical (Hangzhou) Co., Ltd
Organization:
Study Overview
Official Title:
A Phase I First-in-human, Open Label, Multicenter, Dose Escalation and Cohort Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of BB-1705 in Patients With Locally Advanced/Metastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2025-07
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:
The study consists of two phases: dose-escalation (Phase I) and cohort expansion (Phase II).
Detailed Description:
Phase Ia is a dose escalation study to assess the safety and tolerability, and to determine the MTD or MAD and RP2D of BB-1705.
Phase Ib is a cohort expansion study to explore one or more RP2Ds to further assess safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity. Patients with locally advanced and unresectable or metastatic solid tumors who have progressed on prior lines of standard of care therapies will be enrolled in this study if eligible.
Phase Ib is a cohort expansion study to explore one or more RP2Ds to further assess safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity. Patients with locally advanced and unresectable or metastatic solid tumors who have progressed on prior lines of standard of care therapies will be enrolled in this study if eligible.
Study Oversight
Has Oversight DMC:
True
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?: