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

Phase 1

Recruiting

• Conditions: Urothelial Carcinoma; Advanced Solid Tumors; Cholangiocarcinoma
• Interventions: Drug: Drug ICP-192

• Registration Number: NCT04565275
• Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Brief 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).

Study Timeline

• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-21
• Study First Posted: 2020-09-25
• Study Start: 2021-02-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-12
• Last Update Posted: 2023-03-14
• Primary Completion: 2023-11-30
• Study Completion: 2024-04-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICP-192	Drug ICP-192	1. Dose Escalation Phase ICP-192 2. Dose Expansion Phase ICP-192

Primary Outcome Measures

Name	Time	Method
RP2D	Up to 3 years	Phase I: Dose Escalation To determine Recommended Phase 2 Dose (RP2D) for ICP-192
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Up to 3 years	Phase I: Dose Escalation \& Phase II: Dose Expansion To evaluate the safety and tolerability of different doses of ICP-192 in patients with advanced solid tumors
OBD	Up to 3 years	Phase I: Dose Escalation To determine Optimal Biological Dose (OBD) for ICP-192
ORR	Up to 3 years	Phase II: Dose Expansion Objective Response Rate
MTD	Up to 3 years	Phase I: Dose Escalation To determine Maximum Tolerated Dose（MTD) for ICP-192

Secondary Outcome Measures

Name	Time	Method
Peak concentration (Cmax)	Up to 3 years	Phase I: Dose Escalation Peak concentration (Cmax)
OS	Up to 3 years	Phase II: Dose Expansion overall survival
PFS	Up to 3 years	Phase II: Dose Expansion progression-free survival
AUC	Up to 3 years	Phase I: Dose Escalation AUC
DCR	Up to 3 years	Phase II: Dose Expansion disease control rate
DOR	Up to 3 years	Phase II: Dose Expansion duration of response

Trial Locations

Locations (16)

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Arizona Oncology; 🇺🇸 Tucson, Arizona, United States

University of California, San Diego (UCSD) - Moores Cancer Center; 🇺🇸 La Jolla, California, United States

Mid Florida Hematology and Oncology; 🇺🇸 Orange City, Florida, United States

Rocky Mountain Cancer Centers; 🇺🇸 Aurora, Colorado, United States

Minnesota Oncology Hematology; 🇺🇸 Minneapolis, Minnesota, United States

Rutgers Cancer Institute of New Jersey; 🇺🇸 Bronx, New York, United States

Clinical Research Alliance; 🇺🇸 Lake Success, New York, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

Macquarie University Hospital; 🇦🇺 Macquarie Park, New South Wales, Australia

GenesisCare - North Shore; 🇦🇺 St Leonards, New South Wales, Australia

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia

Monash Medical Centre Clayton; 🇦🇺 Clayton, Victoria, Australia

Pindara Private Hospital; 🇦🇺 Benowa, Queensland, Australia

Olivia Newton-John Cancer Research Institute; 🇦🇺 Melbourne, Victoria, Australia

Peninsula & South Eastern Haematology & Oncology Group; 🇦🇺 Frankston, Victoria, Australia