Status and phase
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About
This prospective phase Il study is aim to evaluate the efficacy and safety of FGFR inhibitor combined with immune checkpoint inhibitors in FGFR1/2/3 variant advanced solid tumors.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Age ≥ 18 years;
Histologically or cytologically confirmed unresectable advanced solid tumors with failure or intolerance to standard treatments;
At least one measurable lesion per RECIST v1.1 criteria;
Gene testing confirms FGFR1/2/3 variants, including but not limited to mutations, fusions/rearrangements in solid tumors;
Patients have not previously used specific small molecule multi-target inhibitors of the FGFR pathway, as assessed by investigators, and have been treated with immune checkpoint inhibitors;
ECOG performance status of 0-1;
Expected survival time > 3 months;
Laboratory criteria:
Female subjects of reproductive age must have a negative urine or serum pregnancy test within 3 days prior to the first dose (Cycle 1, Day 1). If the urine test is inconclusive, a blood test is required. Non-reproductive females are defined as post-menopausal for at least one year or surgically sterile;
Subjects with reproductive potential must use contraception with an annual failure rate of less than 1% during treatment and for 120 days after the last study drug dose (or 180 days after the last chemotherapy dose).
Exclusion criteria
Diagnosis of other malignancies within 3 years before the first dose, except for certain treated skin carcinomas and in-situ carcinomas;
Previous treatment with selective FGFR inhibitors;
Receipt of other investigational drugs within 21 days or antitumor drugs within 14 days before the first dose;
Unresolved toxicity from prior treatments unless ≤ Grade 1 or related to alopecia or fatigue;
Known symptomatic CNS metastasis or carcinomatous meningitis. Stable patients post-treatment with no evidence of progression may be eligible if steroid-free for at least 14 days;
History of allogeneic organ or hematopoietic stem cell transplantation;
Abnormal laboratory parameters:
Known HIV infection or positive HIV test;
Active or poorly controlled serious infection;
Need for drainage treatment for pleural effusion, ascites, or pericardial effusion;
Active hepatitis B or C infection with high viral load, or positive HBsAg or anti-HCV antibodies. Patients on antiviral therapy must meet lower thresholds;
Significant uncontrolled heart disease, including recent MI, severe heart failure, or uncontrolled arrhythmias;
Clinically significant ECG changes or history of significant cardiac issues; Screening QTcF interval > 480 ms, or JTc interval if applicable, must be ≤ 340 ms;
Uncontrolled hypertension despite treatment;
Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh grade B or higher cirrhosis;
Major surgery within 4 weeks before the first dose or planned major surgery during the study;
Unresolved complications from prior surgery;
Pregnant or breastfeeding women, or those planning to become pregnant during the study period and for safety follow-up;
Radiotherapy within 4 weeks before the first dose, except for non-CNS palliative radiotherapy with a 2-week washout period;
History of systemic electrolyte imbalance or ectopic soft tissue calcification;
Clinically significant corneal or retinal disease;
Use of potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives before the first dose;
Primary purpose
Allocation
Interventional model
Masking
30 participants in 1 patient group
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Central trial contact
TAO QIN, MD
Data sourced from clinicaltrials.gov
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