NCT03758664

Clinical Study of ICP-192 in Solid Tumors Patients

A Phase I/IIa, Multicenter, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics of ICP-192 in Patients With Advanced Solid Malignancies

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Open-label, non-randomized, Phase I/IIa, dose-escalating, dose-extension, first-in-man study.

Detailed description

The study consisted of a screening period, a treatment period with 21 days of repeated treatment per cycle (duration treatment with ICP-192), and a follow-up period (28 days after last dose). The recruited patients receive a single dose on day 1, then after a 3-day washout period, repeated dosing will be followed. The starting dose is 2 mg, QD, and dose escalation will follow accelerated titration and modified 3+3 dose-finding schema. The dose-limiting toxicity (DLT) assessment period consisted of Cycle 0 (single dose and washout period) and Cycle 1 (21-day cycle).

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	ICP-192	Drug: ICP-192 Dose levels will be escalated following accelerated titration and modified "3+3" dose escalation scheme,

Timeline

• Start date: 2018-12-19
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2018-11-29
• Last updated: 2022-07-06

Locations

7 sites across 1 country: China