An Open-label, Multicenter Study of LOXO-435 (LY3866288) in Advanced Solid Tumor Malignancies with FGFR3 Alterations

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Primary Objectives:

To determine the recommended dose of LOXO-435
in patients with advanced solid tumors harboring
alterations in FGFR3 or its ligands

Secondary Objectives

To determine the safety and tolerability of
LOXO-435 in patients with advanced solid tumors
harboring alterations in FGFR3 or its ligands
To characterize the PK properties of LOXO-435 in
patients with advanced solid tumors harboring
alterations in FGFR3 or its ligands
To characterize the preliminary antitumor activity of
LOXO-435 in patients with advanced solid tumors
harboring alterations in FGFR3 or its ligands

Eligibility

Inclusion Criteria:

Have solid tumor cancer with an FGFR3 pathway alteration on molecular testing in tumor or blood sample that is deemed as actionable

Cohort A1: Presence of an alteration in FGFR3 or its ligands
Cohort A2, B2, B3, and B5: Histological diagnosis of urothelial cancer (UC) that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration
Cohorts B1 and B4: Histological diagnosis of urothelial cancer that is locally advanced or metastatic
Cohort C1: Must have histological diagnosis of a non-urothelial solid tumor malignancy that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration

Cohort A1 and B3: Measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST v1.1)
Cohorts A2, B1, B2, B4, B5, and C1: Measurable disease required as defined by RECIST v1.1

Have adequate tumor tissue sample available. Participants with inadequate tissue sample availability may still be considered for enrollment upon review
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 for Cohorts A1, A2, B3, and B5

Cohort A1/C1: Participant has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating Investigator; OR the participant is refusing the remaining most appropriate standard of care treatment; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies.
Cohort A2, B2, B3 participants must have received at least one prior regimen, and cohorts B1 and B4 participants at least 2 prior regimens, in the locally advanced or metastatic setting
There is no restriction on number of prior therapies

Cohort B5: Participants have not received prior systemic therapy for locally advanced or metastatic UC
FGFR inhibitor specific requirements:

Exclusion Criteria:

Participants with primary central nervous system (CNS) malignancy
Untreated or uncontrolled CNS metastases
Current evidence of corneal keratopathy or retinal disorder. Individuals with asymptomatic ophthalmic conditions may be eligible
Any serious unresolved toxicities from prior therapy
Significant cardiovascular disease
Prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF)
Active uncontrolled systemic infection or other clinically significant medical conditions

Locations

4100 John R
Detroit, MI 48201
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Phone: 1-800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices