Open

A Phase I study for Patients with Advanced Urothelial Carcinoma

To assess the safety and tolerability of FX-909.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

The study involves physical exams, vital signs, ECGs, echocardiogram, blood draws for lab and research, a variety of imaging procedures including CT and MRI scans, and study drug.

Incentives

In-person visits:
more than 12

Phone or online visits:
more than 1

Total length of participation:
5+ years

Looking for Specific Volunteers

Able to participate:

Patient has an unresectable or metastatic solid tumor that has progressed or has defined genetic mutations.
Patient with a measurable or without measurable disease that has been irradiated or progressed after radiation therapy.
Patient must have an archival tissue sample no more than 30 months old available or patient agrees to have a fresh biopsy.
Patients must meet hematologic, chemistry, renal and hepatic lab values per protocol.
Patients must have an echocardiogram performed with an ejection fraction >40%.

Not eligible if:

Patient is female and is prgnanto ro breast feeding.
Patient received therapy within two weeks prior to study drug administration.
Patient has a prior major surgery within four weeks of study drug administration.
Patient has any active and uncontrolled systemic bacterial, viral, or fungal infection requiring treatment.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Matthew Milowsky
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Bladder)
Urinary and Bladder

IRB Number

23-0870

ClinicalTrials.gov

NCT05929235

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