Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2026-01-04 @ 3:36 AM
Study NCT ID:
NCT06046066
Status:
RECRUITING
Last Update Posted:
2025-06-12
First Post:
2023-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study of NM6603 in Advanced Solid Tumors
Sponsor:
NucMito Pharmaceuticals Co. Ltd.
Organization:
Study Overview
Official Title:
A Phase I Study to Determine the Maximum Tolerated Dose and Evaluate Safety, Tolerability, and Pharmacokinetics of NM6603 in Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2025-03
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:
None
Brief Summary:
This study is to assess the MTD and RP2D of NM6603 in adult patients with advanced solid tumors.
Detailed Description:
This is a Phase 1, first-in-human, multicenter, open label, 3+3 dose escalation study designed to evaluate the safety profile, the maximum tolerated dose (MTD), the recommended Phase 2 dose (RP2D), the pharmacokinetic and the preliminary antitumor activity of NM6603 in patients with advanced solid tumors. The study has two parts. In Part 1, NM6603 will be administered once daily. In Part 2, NM6603 will be administered twice daily to explore the effect of twice daily dosing on the pharmacokinetic, safety and tolerability, and anti-tumor activity profile of NM6603,
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?: