Actively Recruiting
Study of FID-022 in Participants With Advanced Solid Tumors
Led by Fulgent Pharma LLC. · Updated on 2025-09-03
24
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this Phase I Clinical Trial is to evaluate the safety and tolerability of FID-022 in patients with advanced solid tumors.
CONDITIONS
Official Title
Study of FID-022 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to provide informed consent before study procedures
- Age 18 years or older
- Confirmed malignant solid tumor that is metastatic, unresectable, progressive, or recurrent with no standard curative treatments, or irinotecan is an appropriate palliative option
- Measurable disease as defined by RECIST version 1.1
- Adequate washout period of at least 21 days or 5 half-lives from prior chemotherapy, radiotherapy, hormonal therapy, biological therapy, or immunotherapy before first FID-022 infusion
- ECOG performance status of 0 or 1
- Recovery from previous treatment toxic effects to Grade 1 or less, with some exceptions for alopecia and controlled anorexia, fatigue, peripheral neuropathy, or hypothyroidism to Grade 2
- Adequate bone marrow and organ function, including ANC ≥1500/mm3, platelet count ≥100,000/mm3, hemoglobin ≥10 g/dL, coagulation within specified limits, creatinine clearance ≥60 mL/min, and liver function within specified limits
- Estimated life expectancy of at least 3 months
- Agreement to use 2 highly effective contraception methods or abstinence from 2 weeks before first infusion and throughout study, continuing after last dose for specified durations
- Negative pregnancy test at screening and on Cycle 1 Day 1 for females of childbearing potential
- Females not of childbearing potential must meet criteria related to surgical or natural menopause
You will not qualify if you...
- Known allergy to irinotecan or similar drugs like topotecan or Trodelvy®
- History of secondary malignancy except certain non-melanoma skin and in situ cancers, or recent curative therapy within 2 years
- Known symptomatic active brain metastases, gliomas, leptomeningeal carcinomatosis, spinal cord compression, or primary brain tumors; only treated asymptomatic brain metastases allowed
- More than 3 prior chemotherapy lines for recurrent/metastatic disease unless approved
- History of interstitial lung disease, intestinal obstruction, inflammatory bowel disease, or gastrointestinal bleeding related to prior irinotecan
- Serious medical or psychiatric disorders that could affect safety or study data
- Uncontrolled HIV infection with CD4+ cells <350/mm3
- Positive viral load for hepatitis B or C unless adequately treated
- Need for systemic steroids above 10 mg prednisone equivalent daily
- Use of UGT1A1 or CYP3A4 inhibitors or inducers within 14 days before first infusion
- Known UGT1A1 deficiency including Gilbert's syndrome
- QTcF interval ≥470 msec
- Participation in another investigational study within 4 weeks unless in follow-up phase for at least 4 weeks
- Pregnancy, breastfeeding, or plans to become pregnant during study or within 24 weeks after last infusion
- Plans to donate or retrieve eggs during study or within 24 weeks after last infusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033
Actively Recruiting
Research Team
F
Fulgent Pharma
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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