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RecruitingPhase 1NCT06694480

Study of FID-022 in Participants With Advanced Solid Tumors

◆ AI Clinical Summary

This is an early-stage study testing a new drug called FID-022 in people with advanced solid tumors that have not responded to standard treatments. The main goal is to determine how safe the drug is and what side effects patients might experience at different dose levels.

Key Objective:This trial is testing whether FID-022 can be safely administered to cancer patients, with the potential to develop a new treatment option for advanced solid tumors.

Who to Consider:Patients with advanced solid tumors who have exhausted standard treatment options and are willing to participate in early-stage research may want to consider enrolling.

Trial Parameters

ConditionAdvanced Solid Tumors
SponsorFulgent Pharma LLC.
Study TypeINTERVENTIONAL
PhasePhase 1
Enrollment24
SexALL
Min Age18 Years
Max AgeN/A
Start Date2025-07-03
Completion2027-12-31
Interventions
FID-022

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Brief Summary

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

Eligibility Criteria

Inclusion Criteria: 1. Ability to understand and willingness to provide informed consent before the start of any study-specific procedures. 2. Age ≥18 years old. 3. Histologically- or cytologically confirmed malignant solid tumor that is metastatic, unresectable, progressive, or recurrent, and for which there are no standard curative measures, or for whom irinotecan is considered an appropriate palliative treatment option. Patients with known primary brain tumors will be excluded. 4. Measurable disease according to RECIST version 1.1. 5. Adequate treatment washout period of ≥21 days or 5 half-lives, whichever is shorter, for prior chemotherapy, radiotherapy, hormonal therapy, biological therapy, or immunotherapy before the first infusion of FID-022. Note: Palliative radiation is permitted but not ≤14 days before the first infusion of FID-022. 6. ECOG PS of 0 or 1. 7. Recovery from any toxic effects of previous chemotherapy, immunotherapy, targeted therapy, or radiotherapy, as judged by

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