Spots Global Cancer Trial Database for Safety, Tolerability, PK/PD & Preliminary Efficacy of SKL27969 in Advanced Solid Tumors Patients

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

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

Study ID: NCT05388435

Conditions

Advanced Solid Tumor

Interventions

SKL27969

Study Description

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

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