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LOXO-435

Phase 1

Urinary Bladder Neoplasms | Small molecule | Oncology |Eli Lilly and Company|Last Updated: May 19, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment535
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05614739FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3PHASE1 RECRUITING 535 — — Jan 12, 2023Jun 1, 2027May 19, 202682 United States, Australia +12
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Study Endpoints
Primary Endpoints
Phase 1a: To determine the recommended dose of LOXO-435: Safety, number of participants with dose-limiting toxicities (DLTs)
Minimum of the first 21-day cycle of LOXO-435 treatment

Number of participants with DLTs

Phase 1b: To evaluate the preliminary antitumor activity of LOXO-435: Overall response rate (ORR)
Up to approximately 30 months or 2.5 years

ORR per investigator assessed RECIST v1.1

Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Up to approximately 30 months or 2.5 years

A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module

Secondary Endpoints
To assess the pharmacokinetics (PK) of LOXO-435: Area under the concentration versus time curve (AUC)
Up to 2 months
To assess the PK of LOXO-435: Minimum plasma concentration (Cmin)
Up to 2 months
To evaluate the preliminary antitumor activity of LOXO-435: Objective response rate (ORR)
Up to approximately 30 months or 2.5 years]
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1a: Cohort A1 LOXO-435 Monotherapy Dose EscalationEXPERIMENTALLOXO-435 administered orally
Phase 1a: Cohort A2 LOXO-435 Monotherapy Dose OptimizationEXPERIMENTALLOXO-435 administered orally
Phase 1b: Cohort B1, B2, B4, and C1 LOXO-435 Monotherapy Dose ExpansionEXPERIMENTALLOXO-435 administered orally
Phase 1b: Cohort B3 LOXO-435 Plus PembrolizumabEXPERIMENTALLOXO-435 administered orally in combination with pembrolizumab administered intravenously (IV)
Phase 1b: Cohort B5 LOXO-435 Plus Pembrolizumab Plus Enfortumab VedotinEXPERIMENTALLOXO-435 administered orally in combination with pembrolizumab administered IV and enfortumab vedotin administered IV
Interventions
NameTypeDescription
LOXO-435DRUGOral
PembrolizumabDRUGIV
enfortumab vedotinDRUGIV
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites82

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)...

Countries:United StatesAustraliaCanadaChinaFranceGermanyIsraelItalyJapanNetherlandsNorwaySouth KoreaSpainUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05614739primaryCompletionDate: changed
LOWMay 24, 2026NCT05614739studyFirstPostDate: changed