FID-022 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and tolerability of a new drug, FID-022, for individuals with advanced solid tumors—cancers that have spread and are typically inoperable. Participants will receive the drug in increasing doses to determine the safest tolerable dose. It suits those whose cancer does not respond to standard treatments and whose tumors are growing or recurring. Individuals with solid tumors that cannot be cured with current options and who experience ongoing issues might find this trial suitable. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial requires a washout period (time without taking certain medications) of at least 21 days or 5 half-lives, whichever is shorter, for prior treatments like chemotherapy, radiotherapy, or immunotherapy before starting FID-022. Additionally, you cannot use certain enzyme inhibitors or inducers 14 days before the first infusion.
Is there any evidence suggesting that FID-022 is likely to be safe for humans?
A previous study on FID-022 administered the treatment to patients with advanced solid tumors to assess its safety and tolerability. This early-stage study (Phase 1) focused primarily on safety. Limited information exists on how well patients handle FID-022. As testing continues, researchers are determining the optimal dose and identifying potential side effects. Currently, specific information on side effects or patient tolerance is unavailable, but this trial aims to uncover those details.12345
Why do researchers think this study treatment might be promising for cancer?
Researchers are excited about FID-022 because it offers a fresh approach to cancer treatment. Unlike traditional chemotherapy, which often targets both healthy and cancerous cells, FID-022 is designed to be more selective, potentially reducing side effects. The treatment is administered intravenously in a carefully controlled dose escalation format, allowing researchers to optimize its effectiveness while monitoring safety. The unique dosing schedule—on days 1 and 8 of each 21-day cycle—also provides an innovative way to manage and adjust treatment based on patient response.
What evidence suggests that FID-022 might be an effective treatment for cancer?
Research has shown that FID-022 has produced promising results in early studies. It effectively shrank tumors in animal models of cancer, such as colon and ovarian cancer, when compared to the usual treatment, irinotecan. This suggests that FID-022 might also be effective against certain solid tumors in humans. However, limited information exists about its effects on people. In this trial, participants will join a dose escalation study to evaluate the safety and tolerability of FID-022. Researchers aim for it to perform as well in humans as it has in animals.23678
Who Is on the Research Team?
Clinical Sites
Principal Investigator
Fulgent Pharma LLC.
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors that have spread, can't be surgically removed, or are getting worse. Participants must understand the study and agree to join, have measurable disease by certain criteria (RECIST 1.1), and be in good enough health (ECOG PS of 0 or 1). They should not have had other cancer treatments recently and need to recover from any previous treatment side effects.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation Treatment
Participants receive FID-022 as monotherapy with dose escalation to determine the Maximum Tolerated Dose (MTD)
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- FID-022
Trial Overview
The trial is testing FID-022's safety and how well patients tolerate it when they have advanced solid tumors. It's an early-phase study (Phase I) which means it's mostly looking at what dose might work best without causing too many problems.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients will be sequentially enrolled at progressively higher dose levels to receive FID-022 as monotherapy. According to the study design, maintaining the dose level or moving down a dose level will possibly happen when conditions are met. Intravenous Administration of FID-022, infusion on day 1 and 8 of each 21-day cycle: Dose level 1: 20 mg/m2. Dose level 2: 40 mg/m2. Dose level 3: 60 mg/m2. Dose level 4: 80 mg/m2. Dose level 5: 100 mg/m2. Dose level 6: 120 mg/m2.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fulgent Pharma LLC.
Lead Sponsor
Citations
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