Explore Pipeline
EventsOncology Pipeline
Loxo@Lilly aims to create medicines that make life better for all those affected by cancer around the world. Bringing together the focus and spirit of a biotech with the scale, resources, and heritage of Lilly, our team is focused on rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating oncology medicines that unequivocally show early signs of clinical activity and will matter to patients.
NCT05614739
Advanced Solid Tumors
FGFR3 Inhibitor
An Open-Label, Multicenter Study of LOXO-435 (LY3866288) in Advanced Solid Tumor Malignancies With FGFR3 Alterations*
Key Inclusion Criteria
- 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 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): 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 version 1.1 (RECIST v1.1)
- Cohorts A2, B1, B2, B3, and C1: Measurable disease as defined by RECIST v1.1
- Adequate archival tumor tissue sample available or undergo a screening biopsy, if allowed per country-specific regulations
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Prior systemic therapy criteria:
- Cohorts A1 and C1: Participant has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies
- Cohorts A2, B1, B2, and 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:
- Cohorts A1 and A2: Prior FGFR inhibitor treatment is permitted, but not required
- Cohort B1: Participants must have been previously treated with a FGFR inhibitor
- Cohorts B2, B3, and C1: Participants must be FGFR inhibitor naïve
Key Exclusion Criteria
- Primary central nervous system (CNS) malignancy
- Uncontrolled CNS metastases
- Current evidence of corneal keratopathy or retinal disorder
- History and/or current evidence of extensive tissue calcification
- Any unresolved serious 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
- 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
Contact the Lilly Oncology Clinical Trial Navigation Service
Visit www.clinicaltrials.gov for more information on this trial.
Need additional information or have a question:
The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.