Clinical trial NCT02221882: A Study of LY3164530 in Participants With Cancer
Official title: A Phase 1 Study of LY3164530, a Bispecific Antibody Targeting Mesenchymal-Epithelial Transition Factor (MET) and Epidermal Growth Factor Receptor (EGFR), in Patients With Advanced or Metastatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Neoplasm Metastasis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-08-21
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the safety of a study drug known as LY3164530 in participants with cancer that is advanced and/or has spread to another part(s) of the body.


Eligibility criteria: Inclusion Criteria

* Have advanced or metastatic cancer and be an appropriate candidate for experimental therapy.
* Have adequate organ function.
* Prior Treatments:

  * Systemic treatments: Must have discontinued previous systemic treatments for cancer and recovered from the acute effects of therapy. Participants must have discontinued:

    * Cytotoxic therapies or targeted agents that are small molecule inhibitors for 5 half-lives or at least 28 days.
    * Mitomycin-C or nitrosourea therapy for at least 42 days and biologic agents for at least 28 days.
  * Radiation therapy and surgery must be completed 4 weeks prior to therapy, except for limited field radiation therapy, which must be completed 2 weeks before therapy.
* If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for three 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 14 days of the first dose of study drug and must not be breast feeding.

Exclusion Criteria:

* Must not have taken an unapproved drug as treatment for any indication within the last 28 days prior to starting study treatment.
* Must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C.
* Must not have a serious preexisting medical conditions or concomitant disorders.
* Must not have leukemia.
* Must not have QT interval of \>470 millisecond.
* Must not have a serious cardiac condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last 3 months.

Primary outcomes:
measure: Recommended Phase 2 Dose of LY3164530: Maximum Tolerated Dose (MTD)
timeFrame: Cycle 1 (Cycle = 28 days)
Secondary outcomes:
measure: Maximum Serum Concentration (Cmax) of LY3164530 Epidermal Growth Factor Receptor (EGFR) Specific ELISA Assay
timeFrame: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
measure: Maximum Serum Concentration (Cmax) of LY3164530 Mesenchymal-Epithelial Transition Factor (MET) Specific ELISA Assay
timeFrame: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
measure: Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 EGFR Specific ELISA Assay
timeFrame: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
measure: Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 MET Specific ELISA Assay
timeFrame: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
measure: Number of Participants With Tumor Response
timeFrame: Baseline Through Study Completion (Up to 6 Months)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Pinnacle Oncology Hematology
state: Arizona
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: The START Center for Cancer Care
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: