NCT04565275

A Study of ICP-192 in Patients With Advanced Solid Tumors

A Multi-center Open-label, Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-192 in Patients With Advanced Solid Tumors and FGFR Gene Alterations

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, open-label, phase I/II clinical study to evaluate ICP-192 in patients with advanced solid tumors and FGFR gene alterations. It consists of two parts: Part I (Phase I), dose escalation and Part II (Phase II), dose expansion.

Detailed description

Part I (Phase I) of the study enrolls patients with advanced solid tumors (9-15 patients); Part II (Phase II) of the study enrolls patients with urothelial carcinoma or cholangiocarcinoma with FGFR genetic alterations (30 patients).

Conditions

• Advanced Solid Tumors
• Urothelial Carcinoma
• Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Drug ICP-192	1. Dose Escalation Phase ICP-192 will be taken by patients with advanced solid tumor and will be treated follow the "3+3" dose escalation scheme 2. Dose Expansion Phase ICP-192 will be taken by patients with urothelial carcinoma or cholangiocarcinoma with FGFR gene alterations and will be treated at a single dose defined from the Dose Escalation Phase.

Timeline

• Start date: 2021-02-01
• Primary completion: 2023-11-30
• Completion: 2024-04-15
• First posted: 2020-09-25
• Last updated: 2023-03-14

Locations

16 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study