Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2026-01-01 @ 9:35 PM
Study NCT ID:
NCT06678659
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2024-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer
Sponsor:
Recursion Pharmaceuticals Inc.
Organization:
Study Overview
Official Title:
A Phase 1 / 2, Open-Label Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer
Status:
RECRUITING
Status Verified Date:
2025-12
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:
DAHLIA
Brief Summary:
This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary activity of REC-1245 administered orally on a once daily (QD) schedule in participants with unresectable, locally advanced, or metastatic solid tumors.
Detailed Description:
Approximately 85 participants will be enrolled in this open-label Phase 1/2 study, allocated 55 participants in Phase 1 and 10-30 participants in Phase 2. The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of REC-1245 for the treatment of participants with unresectable locally advanced or metastatic solid tumors. Participants will receive treatment with REC-1245 for up to 2 years.
Study Oversight
Has Oversight DMC:
False
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?: