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

NCT05971862 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-02-21

No results posted yet for this study

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.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

SKI-G-801

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

Sponsors & Collaborators

  • Oscotec Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05971862 on ClinicalTrials.gov