A Study of LOXO-435 in Patients With Cancer With a Change in a Gene Called FGFR3
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.
- 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.
- 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
Join this Trial
- UCLA Burbank
- UCLA Encino
- UCLA San Luis Obispo
- UCLA Santa Barbara
- UCLA Santa Monica
- UCLA Torrance
- UCLA Ventura
- UCLA Westlake Village