Study Details

Open

An Open-label, Multicenter Study of LOXO-435 in Advanced Solid Tumor Malignancies with FGFR3 Alterations

Phase 1a Primary Objective: To determine the recommended dose of LOXO-435 in patients with advanced solid tumors harboring alterations in fibroblast growth factor receptor (FGFR)-3 or its ligands. Phase 1b Primary Objective: To assess the antitumor activity of LOXO-435 as monotherapy or in combination with pembrolizumab in patients with advanced solid tumors harboring prespecified activating FGFR3 alterations.

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, blood draws for labs and research, eye exams by an ophthalmologist, a variety of imaging procedures that include CT and MRI scans, submission of biopsy tissue, paper questionnaires, and study drug.

Incentives

Study drug will be provided.

In-person visits:
more than 10

Phone or online visits:
more than 1

Total length of participation:
2.5 years

Looking for Specific Volunteers

Able to participate:

All patients must have tissue that confirms their cancer is advanced or has spread to other parts (metatastic with an FGFR3 pathway alteration.
Patient must have a life expectancy of >12 weeks.
Patient must have adequate tumor tissue from a previous biopsy available or be willing to undergo a screeing biopsy.
Patient must have received all standard treatment for their cancer, OR patient refuses remaining standard treatments for their cancer.
Patient must be able to consume pills and adhere to outpatient treatment, laboratory monitoring, and necessary clinic visits for the duration of the study.

Not eligible if:

There is no restriction on the number of prior treatment, however, patients who have received certain therapies with a specified window may be excluded.
Patients whose cancer is uncontrolled and has spread to the brain or other parts of the central nervious system.
Patients with any moderate unresolved toxicity from prior cancer treatments.
Patients with a known active Hepatitis B, C, or HIV infection.
Patients with a second active cancer (some exceptions).

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, Other Cancers)

IRB Number

22-2336

ClinicalTrials.gov

NCT05614739