NCT05388435

Safety, Tolerability, PK/PD & Preliminary Efficacy of SKL27969 in Advanced Solid Tumors Patients

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: SK Life Science, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	SKL27969	SKL27969 will be orally administered once daily on an intermittent dosing schedule (3 days on and 4 days off).

Timeline

• Start date: 2022-09-12
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2022-05-24
• Last updated: 2025-05-04

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study