NCT02529553

Brief Summary

The main purpose of this study is to evaluate the safety of the study drug known as LY3076226 in participants with advanced or metastatic cancer.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2015

Typical duration for phase_1

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2015

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2018

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

April 17, 2020

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

2.6 years

First QC Date

August 19, 2015

Results QC Date

March 8, 2020

Last Update Submit

April 9, 2020

Conditions

Advanced CancerMetastatic Cancer

Keywords

bladder cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD) of LY3076226

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

    Cycle 1 (21 Days)

Secondary Outcomes (3)

  • 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)

Study Arms (1)

LY3076226

EXPERIMENTAL

Part 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.

Drug: LY3076226

Interventions

LY3076226DRUG

Administered IV

LY3076226

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug. If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 7 days of the first dose of study drug and must not be breastfeeding.

You may not qualify if:

  • Have received treatment within 28 days of the initial dose of study drug with an investigational product or non-approved use of a drug or device (other than the study drug/device used in this study) or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Have preexisting corneal disease that may interfere with assessment for potential eye toxicity during the study.
  • Have preexisting Grade ≥2 skin disorder (for example, erythema, dermatitis).
  • Have serious preexisting medical conditions (left to the discretion of the investigator).
  • Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required). Participants with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids and/or anticonvulsants, and their disease is asymptomatic and radiographically stable for at least 28 days.
  • Have current acute or chronic leukemia.
  • Have an active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
  • Have a second primary malignancy that, in the judgment of the investigator and sponsor, may affect the interpretation of results. Curatively treated nonmelanoma skin cancer or in situ carcinoma of any origin is allowed.
  • Have Fridericia-corrected QT interval (QTcF) \>480 milliseconds on screening electrocardiogram (ECG).
  • Have a serious cardiac condition, such as congestive heart failure; New York Heart Association Class III/IV heart disease; unstable angina pectoris; myocardial infarction within the last 3 months; valvulopathy that is severe, moderate, or deemed clinically significant; or arrhythmias that are symptomatic or require treatment (not including participants with rate-controlled atrial fibrillation).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

The START Center for Cancer Care

San Antonio, Texas, 78229, United States

Location

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Related Publications (1)

  • Kollmannsberger C, Britten CD, Olszanski AJ, Walker JA, Zang W, Willard MD, Radtke DB, Farrington DL, Bell-McGuinn KM, Patnaik A. A phase 1 study of LY3076226, a fibroblast growth factor receptor 3 (FGFR3) antibody-drug conjugate, in patients with advanced or metastatic cancer. Invest New Drugs. 2021 Dec;39(6):1613-1623. doi: 10.1007/s10637-021-01146-x. Epub 2021 Jul 15.

    PMID: 34264412DERIVED

Related Links

MeSH Terms

Conditions

Neoplasm MetastasisUrinary Bladder Neoplasms

Interventions

LY3076226

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Limitations and Caveats

Due to pipeline reprioritization, development of LY3076226 was discontinued at the end of 2017 and no further patients were enrolled.

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2015

First Posted

August 20, 2015

Study Start

September 1, 2015

Primary Completion

March 28, 2018

Study Completion

March 28, 2018

Last Updated

April 17, 2020

Results First Posted

April 17, 2020

Record last verified: 2020-04

Locations

US(3)CA(1)