Condition: Urinary Bladder Neoplasms, Neoplasm Metastasis, Ureteral Neoplasms

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05614739

Sponsor: Eli Lilly and Company

Phase: Phase 1

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

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
• Measurability of disease:
• 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
• Less than or equal to 2 for Cohorts B1, B2, B4, and C1
• Prior Systemic Therapy Criteria:
• 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:
• Cohort A1/A2/B3: Prior FGFR inhibitor treatment is permitted but not required
• Cohort B1/B4: Participants must have been previously treated with erdafitinib
• Cohort B2, B5, and C1: Participants must be FGFR inhibitor naïve

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
• Participants who are pregnant, lactating, or plan to breastfeed during the study or within 6 months of the last dose of study treatment. Participants who have stopped breastfeeding may be enrolled

View trial on ClinicalTrials.gov