FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3

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