NCT03317743

Study to Assess the Safety & Tolerability of NOV140101(IDX-1197) in Patients With Advanced Solid Tumors

Open-label, Phase I Clinical Trial to Identify Optimal Dose and Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and the Anti-cancer Efficacy of NOV140101(IDX-1197HCl) in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Idience Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

the purpose of this open-label, dose escalation-dose expansion, Phase 1 clinical trial is to evaluate the safety, pharmacokinetics and anti-tumor activity and determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of NOV140101 (IDX-1197).

Detailed description

This is an open-label, Phase 1 dose escalation study of NOV140101 (IDX-1197) to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and the anti-tumor efficacy of IDX-1197 in patients with advanced solid tumors after failure of standard of care. DLTs will be assessed as the primary endpoint in this trial.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	NOV140101 (IDX-1197)	The dose levels will be escalated following a 3+3 dose escalation scheme.

Timeline

• Start date: 2017-08-29
• Primary completion: 2020-12-08
• Completion: 2021-10-13
• First posted: 2017-10-23
• Last updated: 2026-04-17

Locations

1 site across 1 country: South Korea