Skip to main content
OpenTrials
Completed

NCT Number: NCT02221882

A Study of LY3164530 in Participants With Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neoplasms Neoplasm Metastasis Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pinnacle Oncology Hematology, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY3164530

Drug

Administered IV.

Primary outcomes

  1. Recommended Phase 2 Dose of LY3164530: Maximum Tolerated Dose (MTD)

    Time frame: Cycle 1 (Cycle = 28 days)

    Recommended Phase 2 Dose of LY3164530: MTD

Secondary outcomes

  1. Maximum Serum Concentration (Cmax) of LY3164530 Epidermal Growth Factor Receptor (EGFR) Specific ELISA Assay

    Time frame: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)

    Cmax in Schedule (Sched) 1 Cycle 1 (C1) and Cycle 2 (C2) and Sched. 2 C1 and C2 dose escalation based on EGFR specific ELISA assay.

    Pharmacokinetic (PK) Time Frame Schedule 1:Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2 hours (hrs), 4hrs, 6hrs, 24 ±4hrs post-infusion; Day 3: anytime during day; Day 8 ±1 : anytime during day. Day 15: Pre-dose, End of infusion; 2hrs, 4hrs, 6hrs post-infusion; Day 22 ±2: anytime during day. Cycles 3-6: Pre-dose, End of infusion.

    PK Time Frame: Schedule 2: Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 3: anytime during day; Day 8: Pre-dose; End of infusion; Day 22: Pre-dose; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 24: anytime during day. Cycles 3-6: Pre-dose; End of Infusion.

  2. Maximum Serum Concentration (Cmax) of LY3164530 Mesenchymal-Epithelial Transition Factor (MET) Specific ELISA Assay

    Time frame: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)

    Cmax in Schedule 1 Cycles 1 and 2 and Schedule 2 Cycles 1 and 2 based on the MET-specific ELISA assay.

    Pharmacokinetic (PK) Time Frame Schedule 1:Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2 hours (hrs), 4hrs, 6hrs, 24 ±4hrs post-infusion; Day 3: anytime during day; Day 8 ±1 : anytime during day. Day 15: Pre-dose, End of infusion; 2hrs, 4hrs, 6hrs post-infusion; Day 22 ±2: anytime during day. Cycles 3-6: Pre-dose, End of infusion.

    PK Time Frame: Schedule 2: Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 3: anytime during day; Day 8: Pre-dose; End of infusion; Day 22: Pre-dose; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 24: anytime during day. Cycles 3-6: Pre-dose; End of Infusion.

  3. Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 EGFR Specific ELISA Assay

    Time frame: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)

    Area under the serum concentration-time curve of LY3164530 over the dosing interval (AUC[0-τ]) from time 0 to 336 hours (τ) [Schedule 1] or from time 0-168 hours (τ) [Schedule 2].

    Pharmacokinetic (PK) Time Frame Schedule 1:Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2 hours (hrs), 4hrs, 6hrs, 24 ±4hrs post-infusion; Day 3: anytime during day; Day 8 ±1 : anytime during day. Day 15: Pre-dose, End of infusion; 2hrs, 4hrs, 6hrs post-infusion; Day 22 ±2: anytime during day. Cycles 3-6: Pre-dose, End of infusion.

    PK Time Frame: Schedule 2: Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 3: anytime during day; Day 8: Pre-dose; End of infusion; Day 22: Pre-dose; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 24: anytime during day. Cycles 3-6: Pre-dose; End of Infusion.

  4. Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 MET Specific ELISA Assay

    Time frame: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)

    Area under the serum concentration-time curve of LY3164530 over the dosing interval (AUC[0-τ]) from time 0 to 336 hours (τ) [Schedule 1] or from time 0-168 hours (τ) [Schedule 2].

    Pharmacokinetic (PK) Time Frame Schedule 1:Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2 hours (hrs), 4hrs, 6hrs, 24 ±4hrs post-infusion; Day 3: anytime during day; Day 8 ±1 : anytime during day. Day 15: Pre-dose, End of infusion; 2hrs, 4hrs, 6hrs post-infusion; Day 22 ±2: anytime during day. Cycles 3-6: Pre-dose, End of infusion.

    PK Time Frame: Schedule 2: Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 3: anytime during day; Day 8: Pre-dose; End of infusion; Day 22: Pre-dose; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 24: anytime during day. Cycles 3-6: Pre-dose; End of Infusion.

  5. Number of Participants With Tumor Response

    Time frame: Baseline Through Study Completion (Up to 6 Months)

    Number of Participants with Tumor Response

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 21, 2014
Registry last updated
Oct 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.