NCT03642834

Study of ICP-105 in Solid Tumors Patients

A Phase I, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics of ICP-105 in Patients With Advanced Solid Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The study consisted of a screening period, a treatment period with repeated 28-day treatment cycles (duration treatment with ICP-105), and a follow-up period (within 30 days of the last dose and post-treatment follow-up 30 days after the last visit). The recruited patients receive a single dose on day 1, then after a 3-day washout period, multiple dosing will be initiated following dose-escalation schedule. The dose-limiting toxicity (DLT) assessment period consisted of Cycle 0 (single dose and washout period) and Cycle 1 (28-day cycle).

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	ICP-105	25mg, 100mg capsule

Timeline

• Start date: 2018-09-21
• Primary completion: 2020-12-14
• Completion: 2021-03-01
• First posted: 2018-08-22
• Last updated: 2022-07-06

Locations

1 site across 1 country: China