A Study of LY3164530 in Participants With Cancer

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02221882
• Other study ID #: 15279
• Secondary ID: I7H-MC-JNBA
• Status: Completed
• Phase: Phase 1
• Start date: August 2014
• Est. completion date: March 7, 2017

Study information

• Verified date: October 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 7, 2017
• Est. primary completion date: March 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Neoplasms

Intervention

Drug:
• LY3164530
Administered IV.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	The START Center for Cancer Care	San Antonio	Texas
United States	Pinnacle Oncology Hematology	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recommended Phase 2 Dose of LY3164530: Maximum Tolerated Dose (MTD)	Recommended Phase 2 Dose of LY3164530: MTD	Cycle 1 (Cycle = 28 days)
Secondary	Maximum Serum Concentration (Cmax) of LY3164530 Epidermal Growth Factor Receptor (EGFR) Specific ELISA Assay	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.	Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
Secondary	Maximum Serum Concentration (Cmax) of LY3164530 Mesenchymal-Epithelial Transition Factor (MET) Specific ELISA Assay	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.	Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
Secondary	Area Under the Serum Concentration-Time Curve (AUC[0-t]) of LY3164530 EGFR Specific ELISA Assay	Area under the serum concentration-time curve of LY3164530 over the dosing interval (AUC[0-t]) from time 0 to 336 hours (t) [Schedule 1] or from time 0-168 hours (t) [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.	Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
Secondary	Area Under the Serum Concentration-Time Curve (AUC[0-t]) of LY3164530 MET Specific ELISA Assay	Area under the serum concentration-time curve of LY3164530 over the dosing interval (AUC[0-t]) from time 0 to 336 hours (t) [Schedule 1] or from time 0-168 hours (t) [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.	Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
Secondary	Number of Participants With Tumor Response	Number of Participants with Tumor Response	Baseline Through Study Completion (Up to 6 Months)