Phase
Condition
Liver Cancer
Urothelial Carcinoma
Abdominal Cancer
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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.
Study Design
Study Description
Connect with a study center
Macquarie University Hospital
Macquarie Park, New South Wales 2109
AustraliaActive - Recruiting
GenesisCare - North Shore
St Leonards, New South Wales 1590
AustraliaActive - Recruiting
Westmead Hospital
Westmead, New South Wales 2145
AustraliaActive - Recruiting
Pindara Private Hospital
Benowa, Queensland 4217
AustraliaActive - Recruiting
Monash Medical Centre Clayton
Clayton, Victoria 3168
AustraliaActive - Recruiting
Peninsula & South Eastern Haematology & Oncology Group
Frankston, Victoria 3199
AustraliaActive - Recruiting
Olivia Newton-John Cancer Research Institute
Melbourne, Victoria 3084
AustraliaActive - Recruiting
Arizona Oncology
Tucson, Arizona 85711
United StatesActive - Recruiting
University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla, California 92037
United StatesActive - Recruiting
Rocky Mountain Cancer Centers
Aurora, Colorado 80012
United StatesActive - Recruiting
Mid Florida Hematology and Oncology
Orange City, Florida 32763
United StatesSite Not Available
Minnesota Oncology Hematology
Minneapolis, Minnesota 55404
United StatesActive - Recruiting
Rutgers Cancer Institute of New Jersey
Bronx, New York 10462
United StatesActive - Recruiting
Clinical Research Alliance
Lake Success, New York 11042
United StatesActive - Recruiting
The Ohio State University
Columbus, Ohio 43210
United StatesActive - Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas 77001
United StatesActive - Recruiting
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