CLINICAL TRIAL / NCT05614739

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 (Dose Escalation): Presence of an alteration in FGFR3 or its ligands. - Cohort A2 (Dose Optimization): Histological diagnosis of urothelial cancer (UC) that is locally advanced or metastatic with a qualifying FGFR3 alteration. - 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: - Cohort A1: Measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST v1.1) - Cohorts A2, B1, B2, B3, and C1: 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. - 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/B1/B2/B3: Participants must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies. - FGFR inhibitor specific requirements: - Cohort A1/A2: Prior FGFR inhibitor treatment is permitted, but not required. - Cohort B1: Participants must have been previously treated with a FGFR inhibitor. - Cohort B2, B3, C1: Participants must be FGFR inhibitor naïve. Exclusion Criteria: - Participants 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. - 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.