A Study of ICP-192 in Patients With Advanced Solid Tumors
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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).
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
Actual Study Start Date :
February 1, 2021
Estimated Primary Completion Date :
October 21, 2022
Estimated Study Completion Date :
February 16, 2023
Resource links provided by the National Library of Medicine
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
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Major Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Participate voluntarily, sign informed consent, and follow the study treatment plan and scheduled visits;
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;
Phase II: patients with histologically or cytologically confirmed unresectable or metastatic urothelial carcinoma or cholangiocarcinoma, who have progressed or recurred after or were intolerant to first-line chemotherapy, or have progressed/relapsed within 12 months after neoadjuvant /adjuvant chemotherapy;
Phase II: Existing test reports have confirmed the FGFR gene alteration or the central laboratory has detected the FGFR gene alteration.
Age ≥18 years old;
At least one measurable lesion according to the Response Evaluation Criteria of Solid Tumor, version 1.1 (RECIST 1.1);
ECOG performance status of 0-1;
Life expectancy for more than 3 months; Must have adequate organ function Major Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Have previously been treated with selective pan-FGFR molecular inhibitors or antibody drugs, except for the FGFR4 selective inhibitors;
Within 2 weeks before the first dose of study drug, the subject's phosphate level continuing to exceed the ULN despite medical treatment;
Patients with clinically significant gastrointestinal dysfunction
Has known central nervous system metastases;
Has a history of or currently uncontrolled cardiovascular diseases
History of organ transplantation or a history of allogeneic hematopoietic stem cell transplantation;
Current evidence of corneal or retinal abnormalities that may increase eye toxicity;
Active hepatitis B virus active hepatitis C, or HIV infection;
Has not recovered from reversible toxicity of prior anti-tumor therapy
Pregnant or lactating women, as well as women with childbearing potential who are unwilling or unable to perform contraception from the screening to 6 months after the last study drug administration; and fertile men who are unwilling or unable to perform contraception from screening to 3months after the last study drug administration
Other conditions considered by the investigator to be inappropriate for participation in this study.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.