drugset / Trial / NCT05971862

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

NCT05971862 ↗

Phase 1 Unknown 36 enrolled Oscotec Inc.
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2022-01-25
Primary completion
2024-04-23
Completion
2024-10-04

Drugs

EvaluationDrugModalityDoseRoute
Subject SKI-G-801 Unknown 100 mg Oral
Subject SKI-G-801 Unknown 150 mg Oral
Subject SKI-G-801 Unknown 225 mg Oral
Subject SKI-G-801 Unknown 300 mg Oral
Subject SKI-G-801 Unknown 400 mg Oral
Subject SKI-G-801 Unknown 500 mg Oral

Indications