Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650514
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
A Phase 2 Pilot Study to Evaluate the Safety and the Anti-Tumour Activity of the Myc Inhibitor OMO-103 Administered Intravenously in Patients with Advanced High-Grade Osteosarcoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Pilot Study to Evaluate the Safety and the Anti-Tumour Activity of the Myc Inhibitor OMO-103 Administered Intravenously in Patients with Advanced High-Grade Osteosarcoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Osteomyc
Brief Summary:
This is an open-label unicentric single-arm Phase 2 pilot study to serve as a proof-of-concept of OMO-103 safety and activity in patients with advanced high-grade osteosarcoma
Patients will be treated at the RP2D 65 mgkg as a weekly IV infusion of OMO-103 to estimate anti-tumour activity and further characterise the safety tolerability PK and PD of OMO-103 in advanced high-grade osteosarcoma patients Ten 10 evaluable patients will be enrolled At least 30 of patients will be 18 years old The first three patients 12-15 years of age will undergo additional safety monitoring
Patients will be treated until progression by RECIST v11 or intolerable toxicity
Patients will be treated at the RP2D 65 mgkg as a weekly IV infusion of OMO-103 to estimate anti-tumour activity and further characterise the safety tolerability PK and PD of OMO-103 in advanced high-grade osteosarcoma patients Ten 10 evaluable patients will be enrolled At least 30 of patients will be 18 years old The first three patients 12-15 years of age will undergo additional safety monitoring
Patients will be treated until progression by RECIST v11 or intolerable toxicity
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None