Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LOXO-435 · 1 trial · 3 indications
Number of participants with DLTs
ORR per investigator assessed RECIST v1.1
A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
| Arm | Type | Description |
|---|---|---|
| Phase 1a: Cohort A1 LOXO-435 Monotherapy Dose Escalation | EXPERIMENTAL | LOXO-435 administered orally |
| Phase 1a: Cohort A2 LOXO-435 Monotherapy Dose Optimization | EXPERIMENTAL | LOXO-435 administered orally |
| Phase 1b: Cohort B1, B2, B4, and C1 LOXO-435 Monotherapy Dose Expansion | EXPERIMENTAL | LOXO-435 administered orally |
| Phase 1b: Cohort B3 LOXO-435 Plus Pembrolizumab | EXPERIMENTAL | LOXO-435 administered orally in combination with pembrolizumab administered intravenously (IV) |
| Phase 1b: Cohort B5 LOXO-435 Plus Pembrolizumab Plus Enfortumab Vedotin | EXPERIMENTAL | LOXO-435 administered orally in combination with pembrolizumab administered IV and enfortumab vedotin administered IV |
| Name | Type | Description |
|---|---|---|
| LOXO-435 | DRUG | Oral |
| Pembrolizumab | DRUG | IV |
| enfortumab vedotin | DRUG | IV |
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)...
LOXO-435 is an investigational small molecule being studied for the treatment of urinary bladder neoplasms, including metastatic disease and ureteral neoplasms. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
LOXO-435 targets FGFR3, a fibroblast growth factor receptor. It is designed to act on cancers that have a change in the FGFR3 gene, as indicated by the ongoing clinical trial.
LOXO-435 is being developed by Eli Lilly and Company, a biopharmaceutical company listed on the stock exchange under the ticker symbol LLY.
LOXO-435 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved for any use.
LOXO-435 is being studied in the FORAGER-1 trial (NCT05614739), a Phase 1 study enrolling 535 participants with cancer that has a change in the FGFR3 gene. The trial is recruiting in multiple countries, including the United States, Australia, Canada, China, and several European and Asian nations.
Yes, LOXO-435 is also known as LY3866288. The FORAGER-1 clinical trial uses this alternative name in its official title.