Study of FID-022 in Participants With Advanced Solid Tumors

Part of paid clinical trials in Duarte, California.

Sponsor
Fulgent Pharma LLC.
Study ID
NCT06694480
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FID-022 — DRUG
    FID-022 is composed of SN38 and irinotecan (a prodrug of SN38) that are encapsulated with a polyethyloxazoline (PEOX) material.

Study Details

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

Key Dates

First listed
Nov 19, 2024
Start date
Jul 3, 2025
Status verified
Sep 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation - Weekly Dose
    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.
  • Experimental: Dose Escalation - Bi-weekly Dose
    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 15 of each 28-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.

Primary Outcome Measure

MTD determination [ Time Frame: Through study completion, approximately 2.5 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Patient Portal
[email protected]
877-547-9145
USC/Norris Comprehensive Cancer Center and HospitalLos AngelesCalifornia90033
General Inquiries
[email protected]
323-865-0451
Moffitt Cancer CenterTampaFlorida33612
Patient Relations
[email protected]
813-699-0050

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAUSC/Norris Comprehensive Cancer Center and Hospital· Los Angeles, CAMoffitt Cancer Center· Tampa, FL

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