Fulgent Pharma LLC.
The goal of this Phase I Clinical Trial is to evaluate the safety and tolerability of FID-022 in patients with advanced solid tumors.
FID-022-001 is a Phase 1, multicenter, open label dose escalation clinical study of FID-022 as monotherapy. FID-022 is composed of topoisomerase inhibitors encapsulated with a polyethyloxazoline material. The study drug is administered through intravenous route. Patients with advanced solid tumor diagnosis without standard curative treatments are the target population (please see the eligibility section)
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…
FID-022 is composed of SN38 and irinotecan (a prodrug of SN38) that are encapsulated with a polyethyloxazoline (PEOX) material.
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