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Study of FID-022 for Advanced Solid Tumors

This study is testing a new treatment called FID-022 for people with advanced solid tumors. FID-022 is an immunotherapy and targeted therapy that uses topoisomerase inhibitors (drugs that stop cancer cells from growing) enclosed in a special material. The main goals are to find the safest dose of FID-022 and to understand its side effects. You may be able to join if you are 18 or older, have a solid tumor that has spread, cannot be removed, or has come back, and for which standard treatments are not working or are not suitable. The study is looking for about 24 participants.

Study design
This is a Phase 1, single-arm study where all 24 participants will receive FID-022. It is an open-label study, meaning both you and the study team will know which treatment you are receiving.
What's involved
FID-022 will be given through an IV (into a vein). The study will monitor for side effects and dose-limiting toxicities (serious side effects) during the first 21 days of treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for treatment-related side effects and dose-limiting toxicities through study completion, which is approximately 2.5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06694480

Study of FID-022 in Participants With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Fulgent Pharma LLC.
~24 participants
Updated 2026-09-08 on ClinicalTrials.gov
What's tested:FID-022

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
MTD determination
Measured over Through study completion, approximately 2.5 years
+2 more outcomes measured

Conditions

Advanced Solid Tumors

Explore related trials

Solid Neoplasm

NCT06694480

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • City of Hope

    Duarte, Californiastudy coordinator listed

    Recruiting

  • Moffitt Cancer Center

    Tampa, Floridastudy coordinator listed

    Recruiting

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Fulgent Pharma
[email protected]
626-434-8896
Email the study team

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Eligibility criteria

Inclusion

ANC ≥1500/mm3 \[growth factor administration is not permitted ≤2 weeks from cycle 1 day 1 (C1D1)\]
Platelet count ≥100,000/mm3 (platelet transfusion is not permitted ≤2 weeks from C1D1)
Hemoglobin ≥10 g/dL (criteria must be met without packed red blood cell transfusion ≤2 weeks from C1D1; chronic treatment with erythropoietin is permitted if the patient is on erythropoietin for ≥8 weeks)
Normal bilirubin or ≤1.0 mg/dL if the local ULN is less than 1.0 mg/dL.
For patients with confirmed liver metastasis, total bilirubin within 1.5 x ULN limit is allowed.
Both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × ULN or ≤5 × ULN if liver metastases present 9. An estimated life expectancy of at least 3 months based on investigator judgment. 10. Male patients and female patients of childbearing potential must agree to use 2 highly effective methods of contraception or practice abstinence from 2 weeks before the first FID-022 infusion and throughout the study. After receiving the last FID-022 dose, female and male patients must agree to continue with 2 highly effective methods for at least 6 and 3 months, respectively. Male patients must refrain from donating sperm during the same period. 11. Negative serum pregnancy test result at screening and on Cycle 1 Day 1 for female patients of childbearing potential. 12. Female patients who are not of childbearing potential should meet at least 1 of the following criteria: have undergone a documented hysterectomy and/or bilateral oophorectomy; have medically confirmed ovarian failure, or achieved postmenopausal status (defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause, or have a serum follicle stimulating hormone level within the laboratory's reference range for postmenopausal women).

What this trial measures

  • MTD determinationThrough study completion, approximately 2.5 years

    Determine the Maximum Tolerated Dose (MTD) of FID-022 in patients with advanced solid tumors

  • Number of participants with a treatment-related adverse events as assessed by NCI-CTCAE version 5.0.Through study completion, approximately 2.5 years

    Frequency and severity of abnormal clinical laboratory results, adverse events (AEs), severity of serious AEs (SAEs) and deaths graded according to the NCI-CTCAE version 5.0

  • Number of Participants with Dose Limiting Toxicity (DLT) events during the DLT monitoring period (first 21 days of dosing)21 days

    DLTs graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 .0. Maximum tolerated dose (MTD) will be determined based on DLT per protocol.