A Study of LOXO-435 in Patients With Cancer With a Change in a Gene Called FGFR3

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-435. LOXO-435 may be used to treat cancer of the cells that line the urinary system and other solid tumor cancers that have a change in a particular gene (known as the FGFR3 gene). Participation could last up to 30 months (2.5 years) and possibly longer if the disease does not get worse.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Loxo Oncology, Inc.
• Treatments: Pembrolizumab

Criteria

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 A (Dose Escalation): Presence of an alteration in FGFR3 or its ligands deemed as a clinically or potentially clinically relevant alteration by the treating Investigator.

• Cohorts B1, B2 and B3 (Dose Expansion): Histological diagnosis of urothelial cancer that is locally advanced or metastatic with a prespecified activating FGFR3 alteration.

• Cohort C (Dose Expansion): Must have histological diagnosis of a non-urothelial solid tumor malignancy that is locally advanced or metastatic with a prespecified activating FGFR3 alteration.

• Measurability of disease:

• Phase 1a: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST v1.1)

• Phase 1b: Measurable disease required as defined by RECIST v1.1

• Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country-specific regulations.

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Patient has received all standard therapies for which the patient was deemed to be an appropriate candidate by the treating Investigator; OR the patient 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 B1: Patients must have been previously treated with a FGFR inhibitor.

• Cohort B2, B3, C1: Patients must be FGFR inhibitor naïve.

Exclusion Criteria:

• Patients with primary central nervous system (CNS) malignancy

• Known or suspected history of uncontrolled CNS metastases

• Current evidence of corneal keratopathy or retinal disorder

• Have a history and/or current evidence of extensive tissue calcification

• 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

• Patients who are pregnant, lactating, or plan to breastfeed during the study or within 6 months of the last dose of study treatment