Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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

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

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 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

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

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

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 nave

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 nave



Exclusion Criteria:

Participants with primary central nervous system (CNS) malignancy

Participants with primary central nervous system (CNS) malignancy

Untreated or uncontrolled CNS metastases

Untreated or uncontrolled CNS metastases

Current evidence of corneal keratopathy or retinal disorder. Individuals with asymptomatic ophthalmic conditions may be eligible

Current evidence of corneal keratopathy or retinal disorder. Individuals with asymptomatic ophthalmic conditions may be eligible

Any serious unresolved toxicities from prior therapy

Any serious unresolved toxicities from prior therapy

Significant cardiovascular disease

Significant cardiovascular disease

Prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF)

Prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF)

Active uncontrolled systemic infection or other clinically significant medical conditions

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

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