Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05712356
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2023-01-26
Brief Title:
A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients with Advanced Solid Tumors
Sponsor:
Lisata Therapeutics Inc
Organization:
Lisata Therapeutics Inc
Study Overview
Official Title:
A Phase 2a Double-blind Placebo-controlled Multi-center Randomized Study Evaluating LSTA1 When Added to Standard of Care SoC Versus Standard of Care Alone in Subjects with Advanced Solid Tumors BOLSTER
Status:
RECRUITING
Status Verified Date:
2024-10
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:
BOLSTER
Brief Summary:
The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in patients with previously untreated cholangiocarcinoma or those that have progressed after first-line treatment for cholangiocarcinoma
The main questions it aims to answer are
is the new drug plus standard treatment safe and tolerable
is the new drug plus standard treatment more effective than standard treatment
The main questions it aims to answer are
is the new drug plus standard treatment safe and tolerable
is the new drug plus standard treatment more effective than standard treatment
Detailed Description:
This is a Phase 2a double-blind placebo-controlled multi-center randomized study of LSTA1 when added to standard of care SoC versus SoC alone in patients with advanced solid tumors The study will include patients with previously untreated cholangiocarcinoma or those that have progressed after first-line treatment for cholangiocarcinoma
The study will consist of a screening period a run-in period a treatment period an end-of-treatment follow-up visit and a long-term follow up period
Participants who provide informed consent will be screened for eligibility within 28 days prior to beginning the study treatment run-in period Once eligibility is confirmed participants will be randomized to one of the two treatment groups SoC placebo vs SoC LSTA1
During the 3-day run-in period participants will only receive the LSTA1 or placebo components of their randomized treatment regimen After the 3-day run-in Cycle 1 of treatment will commence Tumor scans will be performed every 8 weeks 56 days 7 days while on treatment
The study will consist of a screening period a run-in period a treatment period an end-of-treatment follow-up visit and a long-term follow up period
Participants who provide informed consent will be screened for eligibility within 28 days prior to beginning the study treatment run-in period Once eligibility is confirmed participants will be randomized to one of the two treatment groups SoC placebo vs SoC LSTA1
During the 3-day run-in period participants will only receive the LSTA1 or placebo components of their randomized treatment regimen After the 3-day run-in Cycle 1 of treatment will commence Tumor scans will be performed every 8 weeks 56 days 7 days while on treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-503740-14 | EUDRACT_NUMBER | None | None |