Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
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