FID-022 for Cancer

Overseen By Fulgent Pharma

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Fulgent Pharma LLC.

Must not be taking: UGT1A1 inhibitors, CYP3A4 inhibitors

Disqualifiers: Brain tumors, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this Phase I Clinical Trial is to evaluate the safety and tolerability of FID-022 in patients with advanced solid tumors.

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

Measurable disease according to RECIST version 1.1

An estimated life expectancy of at least 3 months based on investigator judgment

Negative serum pregnancy test result at screening and on Cycle 1 Day 1 for female patients of childbearing potential

Exclusion Criteria

Known history of uncontrolled HIV infection defined as CD4+ cells <350/mm3

Patients with a positive viral load assay at time of screening for hepatitis C or hepatitis B

Pregnancy, breastfeeding, or plans to become pregnant during the study or within 24 weeks after the last FID-022 infusion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation Treatment

Participants receive FID-022 as monotherapy with dose escalation to determine the Maximum Tolerated Dose (MTD)

21-day cycles, up to 2.5 years

Infusion on day 1 and 8 of each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: Dose Escalation Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Fulgent Pharma LLC.

Lead Sponsor

Trials

2

Recruited

70+