Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422936
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-13
Brief Title:
Clinical Trial to Evaluate BO-112 in Patients With Basal Cell Carcinoma BCC
Sponsor:
Highlight Therapeutics
Organization:
Highlight Therapeutics
Study Overview
Official Title:
SPOTLIGHT 204 A Multicenter Phase 2b Open-label Non-randomized Clinical Trial to Evaluate Safety Tolerability and Preliminary Efficacy of Intra-lesional BO-112 in Patients With Resectable Primary Low and High Risk Basal Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-07
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:
SPOTLIGHT204
Brief Summary:
This is a multicenter phase 2b open-label non-randomized clinical trial to evaluate safety tolerability pharmacodynamics and preliminary efficacy of intra-lesional BO-112 in patients with resectable primary low and high risk basal cell carcinoma
primary endpoint is complete visual and pathological response at surgery on patient level assessed by central review
secondary endpoints are
1 Occurrence of adverse events AEs serious adverse events SAEs and AEs leading to discontinuation or death on patient level
2 Pathological response at surgery on patient level assessed by the investigator and central review respectively and visual response during the study and at surgery on patient level assessed by the investigator and central review respectively
3 Recurrence at 12 and 24 months after surgery on patient level assessed by the investigator
primary endpoint is complete visual and pathological response at surgery on patient level assessed by central review
secondary endpoints are
1 Occurrence of adverse events AEs serious adverse events SAEs and AEs leading to discontinuation or death on patient level
2 Pathological response at surgery on patient level assessed by the investigator and central review respectively and visual response during the study and at surgery on patient level assessed by the investigator and central review respectively
3 Recurrence at 12 and 24 months after surgery on patient level assessed by the investigator
Detailed Description:
None
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