Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-28 @ 6:21 PM
Study NCT ID:
NCT05388435
Status:
TERMINATED
Last Update Posted:
2025-05-04
First Post:
2022-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, PK/PD & Preliminary Efficacy of SKL27969 in Advanced Solid Tumors Patients
Sponsor:
SK Life Science, Inc.
Organization:
Study Overview
Official Title:
A Phase 1/2, Open-Label, Multicenter, Dose-Finding Study of SKL27969 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy in Patients With Advanced Solid Tumors
Status:
TERMINATED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study has been terminated based on portfolio prioritization. No safety trends or issues were identified at any dose level.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective of Part 1 (Dose Escalation Phase): Evaluate the safety and tolerability of SKL27969, and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of SKL27969
Primary Objective of Part 2 (Dose Expansion Phase): Evaluate the preliminary anti-tumor activity of SKL27969
Primary Objective of Part 2 (Dose Expansion Phase): Evaluate the preliminary anti-tumor activity of SKL27969
Detailed Description:
Secondary Objectives of Part 1 (Dose Escalation Phase):
1. Characterize the pharmacokinetic (PK) profile of SKL27969
2. Evaluate the preliminary anti-tumor activity of SKL27969
Secondary Objectives of Part 2 (Dose Expansion Phase):
1. Investigate the safety and tolerability of SKL27969 at the RP2D in patients with selected tumor types
2. Characterize the PK of SKL27969
1. Characterize the pharmacokinetic (PK) profile of SKL27969
2. Evaluate the preliminary anti-tumor activity of SKL27969
Secondary Objectives of Part 2 (Dose Expansion Phase):
1. Investigate the safety and tolerability of SKL27969 at the RP2D in patients with selected tumor types
2. Characterize the PK of SKL27969
Study Oversight
Has Oversight DMC:
True
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?: