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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
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.
Arizona Oncology
Tucson, Arizona, United States
RECRUITINGIncidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
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
Time frame: Up to 3 years
MTD
Phase I: Dose Escalation To determine Maximum Tolerated Dose(MTD) for ICP-192
Time frame: Up to 3 years
OBD
Phase I: Dose Escalation To determine Optimal Biological Dose (OBD) for ICP-192
Time frame: Up to 3 years
RP2D
Phase I: Dose Escalation To determine Recommended Phase 2 Dose (RP2D) for ICP-192
Time frame: Up to 3 years
ORR
Phase II: Dose Expansion Objective Response Rate
Time frame: Up to 3 years
Peak concentration (Cmax)
Phase I: Dose Escalation Peak concentration (Cmax)
Time frame: Up to 3 years
AUC
Phase I: Dose Escalation AUC
Time frame: Up to 3 years
DCR
Phase II: Dose Expansion disease control rate
Time frame: Up to 3 years
DOR
Phase II: Dose Expansion duration of response
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University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla, California, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, United States
RECRUITINGMid Florida Hematology and Oncology
Orange City, Florida, United States
NOT_YET_RECRUITINGMinnesota Oncology Hematology
Minneapolis, Minnesota, United States
RECRUITINGClinical Research Alliance
Lake Success, New York, United States
RECRUITINGRutgers Cancer Institute of New Jersey
The Bronx, New York, United States
RECRUITINGThe Ohio State University
Columbus, Ohio, United States
RECRUITINGThe University of Texas MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGMacquarie University Hospital
Macquarie Park, New South Wales, Australia
RECRUITING...and 6 more locations
Time frame: Up to 3 years
PFS
Phase II: Dose Expansion progression-free survival
Time frame: Up to 3 years
OS
Phase II: Dose Expansion overall survival
Time frame: Up to 3 years