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LY3076226

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

LY3076226 · 1 trial · 2 indications

Phase 1 1
NCT02529553A Study of LY3076226 in Participants With Advanced or Metastatic CancerAdvanced Cancer
COMPLETED25 Analytics
PHASE1COMPLETED
A Study of LY3076226 in Participants With Advanced or Metastatic Cancer
Advanced CancerUnlock trial analytics

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)
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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
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Eligibility Criteria

Age Range18 Years to 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
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Competitive Landscape -Cancer 5 trials (matched to "Advanced Cancer")

Frequently asked questions about LY3076226

What is LY3076226 used for?

LY3076226 is an investigational small molecule being studied for the treatment of advanced or metastatic cancer. It is in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is intended for patients with advanced cancer who are aged 18 years and older.

Who makes LY3076226?

LY3076226 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company conducted a Phase 1 clinical trial of the drug in participants with advanced or metastatic cancer.

What phase is LY3076226 in?

LY3076226 is in Phase 1 clinical development. A Phase 1 trial of the drug has been completed, but the drug remains investigational and has not received FDA approval. It is not yet available as a marketed therapy for cancer patients.

What clinical trials is LY3076226 in?

LY3076226 has been studied in one clinical trial, identified as NCT02529553, titled "A Study of LY3076226 in Participants With Advanced or Metastatic Cancer." This Phase 1 trial was completed and enrolled 25 participants in the United States and Canada.

Is LY3076226 FDA approved?

LY3076226 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial, but it remains in clinical development. The drug has not been authorized for commercial use in any country.