NCT05971862

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SKI-G-801 in Patients With Advanced Solid Tumors

An Open-label, Multi-center, Dose-escalation and Dose-finding, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SKI- G-801 as Monotherapy in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Oscotec Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I study intended to determine the MTD and RP2D of SKI-G-801 monotherapy by assessing the safety and tolerability including dose-limiting toxicity (DLT) at various dose levels and to explore the efficacy and PK in patients with advanced solid tumors.

Detailed description

This is an open-label, monotherapy study in patients with advanced solid tumors, to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple ascending doses of SKI-O-801(Denfivontinib). A total of 36 subjects are planned to participate in 6 cohorts (traditional 3+3 design). In each cohort, 3 subjects will receive SKI-O-801. Dosing will be initiated with a 100 mg once daily (QD) dose cohort and escalated to 500 mg QD. After 1 cycle (28 days) of treatment if 3 subjects in each cohort have no DLT(Dose Limiting Toxicity), escalate the next dose level by Safety Review Committee decision.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	SKI-G-801	Oral SKI-G-801(Denfivontinib) will be daily administered based on dose level.

Timeline

• Start date: 2022-01-25
• Primary completion: 2024-04-23
• Completion: 2024-10-04
• First posted: 2023-08-02
• Last updated: 2024-02-21

Locations

3 sites across 1 country: South Korea