Overview

This trial is active, not recruiting.

Conditions neoplasms, neoplasm metastasis
Treatment ly3164530
Phase phase 1
Sponsor Eli Lilly and Company
Start date August 2014
End date March 2017
Trial size 45 participants
Trial identifier NCT02221882, 15279, I7H-MC-JNBA

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.

United States Texas
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
LY3164530 in escalating dose cohorts given intravenously (IV) once on Days 1 and 15 or on Days 1, 8, 15, and 22 of a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
ly3164530
Administered IV.

Primary Outcomes

Measure
Recommended Phase 2 Dose of LY3164530: Maximum Tolerated Dose (MTD)
time frame: Cycle 1 (Cycle = 28 days)

Secondary Outcomes

Measure
Maximum Concentration (Cmax) of LY3164530
time frame: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
Area Under the Plasma Concentration-Time Curve of LY3164530
time frame: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
Number of Participants with Tumor Response
time frame: Baseline through study completion (estimated as up to 6 months for each patient)

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Phase 1 Study of LY3164530, a Bispecific Antibody Targeting MET and EGFR, in Patients With Advanced or Metastatic Cancer
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.