Description:
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.
Title
- Brief Title: A Study of LY3076226 in Participants With Advanced or Metastatic Cancer
- Official Title: A Phase 1 Study of LY3076226, a Fibroblast Growth Factor Receptor 3 (FGFR3) Antibody-Drug Conjugate, in Patients With Advanced or Metastatic Cancer
Clinical Trial IDs
- ORG STUDY ID:
15383
- SECONDARY ID:
I7O-MC-JOBA
- NCT ID:
NCT02529553
Conditions
- Advanced Cancer
- Metastatic Cancer
Interventions
Drug | Synonyms | Arms |
---|
LY3076226 | | LY3076226 |
Purpose
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 Arms
Name | Type | Description | Interventions |
---|
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. | |
Eligibility Criteria
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 resolution, except where
otherwise stated in the inclusion criteria, of all clinically significant toxic
effects of prior chemotherapy, surgery, or radiotherapy to Grade ≤1 by National Cancer
Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 (v
4.0).
- 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.
Exclusion Criteria:
- 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).
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Maximum Tolerated Dose (MTD) of LY3076226 |
Time Frame: | Cycle 1 (21 Days) |
Safety Issue: | |
Description: | The MTD was defined as the highest dose tested that had less than 33% probability of causing a dose limiting toxicity (DLT). |
Secondary Outcome Measures
Measure: | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3076226 |
Time Frame: | Predose: Day 1 (Cycle 1) and 63 (Cycle 3); Postdose: 0.05, 1, 3, 6, 24 and 72 hours |
Safety Issue: | |
Description: | |
Measure: | PK: Area Under the Concentration-Time Curve (AUC) of LY3076226 |
Time Frame: | Predose: Day 1 (Cycle 1) and 63 (Cycle 3); Postdose: 0.05, 1, 3, 6, 24 and 72 hours |
Safety Issue: | |
Description: | |
Measure: | Number of Participants With Tumor Response |
Time Frame: | Baseline through Study Completion (Cycle 3, day 21) |
Safety Issue: | |
Description: | Tumor response was assessed using confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST version 1.1). Complete response (CR) was the disappearance of all target and non-target lesions and normalization of tumor marker levels of non-target lesions; partial response (PR) was at least a 30% decrease in the sum of the longest diameter of target lesions. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Eli Lilly and Company |
Trial Keywords
Last Updated
April 17, 2020