Recent Updates
Recently added Catalysts

LY3076226

Phase 1

Advanced Cancer | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Apr 17, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02529553A Study of LY3076226 in Participants With Advanced or Metastatic CancerPHASE1 COMPLETED 25Sep 1, 2015Mar 28, 2018Apr 17, 20204 United States, Canada
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Maximum Tolerated Dose (MTD) of LY3076226
Cycle 1 (21 Days)

The MTD was defined as the highest dose tested that had less than 33% probability of causing a dose limiting toxicity (DLT).

Secondary Endpoints
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3076226
Predose: Day 1 (Cycle 1) and 63 (Cycle 3); Postdose: 0.05, 1, 3, 6, 24 and 72 hours
PK: Area Under the Concentration-Time Curve (AUC) of LY3076226
Predose: Day 1 (Cycle 1) and 63 (Cycle 3); Postdose: 0.05, 1, 3, 6, 24 and 72 hours
Number of Participants With Tumor Response
Baseline through Study Completion (Cycle 3, day 21)
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY3076226EXPERIMENTALPart A (dose escalation in advanced cancer): LY3076226 administered intravenously (IV) on day 1 of each 21 day cycle. Part B (dose expansion in advanced urothelial carcinoma): LY3076226 administered IV on day 1 of each 21 day cycle.
Interventions
NameTypeDescription
LY3076226DRUGAdministered IV
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Have advanced or metastatic cancer and be an appropriate candidate for experimental therapy. * Part B: Have a diagnosis of bladder cancer. * Part B: Have alterations of FGFR3. * Have adequate organ function. * Have discontinued previous treatments for cancer and have reso...

Countries:United StatesCanada
Unlock Eligibility Criteria