ICP-CL-00303

Study Name
	ICP-CL-00303
ClinicalTrials.gov Identifier (if applicable)
	NCT04565275
Clinical Trial Category (check all that apply)
	Beyond First Line Therapy Targeted Therapy
Study Center
Institution Name
	Arizona Oncology-HOPE Division
Institution Address
	603 N. Wilmot Rd., #151
City
	Tuscon
State
	Arizona
Zip Code
	85711
Country
	United States
Phone
	(520) 668-5678
Website
	https://arizonaoncology.com
List additional Institutions (include address, phone number, and website)
	Rocky Mountain Cancer Centers, Aurora, Colorado Mid Florida Hematology, Orange City, Florida Minnesota Oncology HematologyAll updated information can be found on Clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT04565275?term=ICP-192&draw=2&rank=1
Study Contacts
Principal Investigator
	Sudhir Manda
P.I. Phone
	(520) 668-5678
P.I. Email
	stacey.kimbell@usoncology.com
Study Coordinator
	Stacey Kimbell
Study Coordinator Phone
	(520) 668-5678
Study Coordinator Email
	stacey.kimbell@usoncology.com
OVERVIEW – in layman’s terms (150 words max)
	1. Overview: ICP-192 is a novel, irreversible pan-FGFR inhibitor may overcome on-target resistance to first generation FGFR inhibitors (erdafitinib, pemigatinib, rogaratinib, infigratinib, derazatinib). ICP-192 is a highly selective pan-FGFR inhibitor, and has improved safety profiles in comparison to the first generation FGFR inhibitors.
Enrollment
	Active/Recruiting
Study Start Date
	09/25/2020
Estimated Completion Date
	4/15/2024
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
	The study is 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
Inclusion Criteria – Patients Must:
	Phase I: Patients with histologically or cytologically confirmed unresectable or metastatic advanced malignant solid tumors who have progressed under standard treatment or recurred after or were intolerant to all standard treatment regimens, or have no standard treatment available;
Exclusion Criteria – Patients Must NOT:
	Have previously been treated with selective pan-FGFR molecular inhibitors or antibody drugs, except for the FGFR4 selective inhibitors
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
	For dose escalation (Phase 1), there is no requirements for NGS testing prior to enter the study. Laboratory, CT scan, ECG and eye exams are required tests before begin study treatment
POTENTIAL SIDE-EFFECTS – in layman’s terms
	increase phosphate in your blood increase calcium in blood can cause increase in liver function increase triglyceride in blood can cause diarrhea or loose stool can cause blurred vision or visual change can cause damage to kidney function