Ignite Creation Date:
2025-12-24 @ 5:15 PM
Ignite Modification Date:
2025-12-25 @ 2:53 PM
Study NCT ID:
NCT05147350
Status:
TERMINATED
Last Update Posted:
2025-12-05
First Post:
2021-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of RP-6306 With FOLFIRI in Advanced Solid Tumors
Sponsor:
Debiopharm International SA
Organization:
Study Overview
Official Title:
Phase 1 Study of the PKMYT1 Inhibitor RP-6306 in Combination With FOLFIRI for the Treatment of Advanced Solid Tumors
Status:
TERMINATED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decided to terminate the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MINOTAUR
Brief Summary:
The primary purpose of this study is to assess the safety and tolerability of RP-6306 with FOLFIRI in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose (RP2D) and preferred schedule, and assess preliminary anti-tumor activity.
Detailed Description:
To assess the safety and tolerability of RP-6306 in combination with FOLFIRI in patients with eligible, advanced solid tumors. Incidence and severity of treatment-emergent adverse events (TEAEs), laboratory assessments, vital signs, electrocardiograms (ECGs), and use of concomitant medications.
The Sponsor of the study has changed from 'Repare Therapeutics' to 'Debiopharm International SA' in the United States.
The Sponsor of the study has changed from 'Repare Therapeutics' to 'Debiopharm International SA' in the United States.
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?: