FID-007 in Treating Participants With Advanced Solid Tumors

NCT03537690 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-29

No results posted yet for this study

Summary

This phase I trial studies the side effects and best dose of PEOX-based polymer encapsulated paclitaxel FID-007 (FID-007) in treating participants with malignant neoplasms that have spread to other places in the body and do not respond to treatment. FID-007 is a packaged form of the chemotherapy drug paclitaxel, and uses a polyethylozaxoline (PEOX) polymer which may allow the drug to reach deeper into tumors and less into normal cells by being smaller.

Conditions

  • Advanced Malignant Solid Neoplasm
  • Refractory Malignant Solid Neoplasm

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

PEOX-based Polymer Encapsulated Paclitaxel FID-007

Given IV

OTHER

Pharmacokinetic Study

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • University of Southern California

    lead OTHER

Principal Investigators

  • Anthony El-Khoueiry, MD · University of Southern California

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-25
Primary Completion
2026-12-31
Completion
2027-05-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03537690 on ClinicalTrials.gov