NeoplasmsPhase 1NCT02221882

A Study of LY3164530 in Participants With Cancer

A Phase 1 study testing LY3164530 in people with Neoplasms and Neoplasm Metastasis, run by Eli Lilly and Company at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Neoplasms, Neoplasm Metastasis
What is being tested?: LY3164530
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 3 sitesUnited States
Study dates: Aug 2014to 7 Mar 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
The START Center for Cancer Care
San Antonio, Texas, 78229
Pinnacle Oncology Hematology
Scottsdale, Arizona, 85258

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About this study

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

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.

Conditions: Neoplasms, Neoplasm Metastasis
Being tested: LY3164530
Medical subject headings: Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY3164530Drug
Administered IV.

Study groups in NCT02221882
Study group	Role	What they receive
LY3164530	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. Receives: Drug: LY3164530

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

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.
Measured: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
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.
Measured: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 EGFR Specific ELISA Assay
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.
Measured: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 MET Specific ELISA Assay
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.
Measured: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
Number of Participants With Tumor Response
Number of Participants with Tumor Response
Measured: Baseline Through Study Completion (Up to 6 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 20147 Mar 2017

First posted21 Aug 2014 (estimated)
Study startAug 2014
Primary completion7 Mar 2017
Study completion7 Mar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for NeoplasmsStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02221882
Sponsor's protocol ID: 15279
Other IDs: I7H-MC-JNBA
Status last verified: Oct 2019
First submitted: 19 Aug 2014
Last updated: 23 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02221882
Acronym / sponsor ID: 15279
Conditions: Neoplasms, Neoplasm Metastasis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Aug 2014
Primary completion: 7 Mar 2017 (actual)
Study completion: 7 Mar 2017 (actual)
First posted: 21 Aug 2014 (estimated)
Results: Posted 23 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LY3164530	Experimental	Drug: LY3164530LY3164530 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY3164530Administered IV.	Drug	LY3164530

Primary outcome

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

5 secondary outcomes

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)
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)
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 (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)
Number of Participants With Tumor Response
Time frame: Baseline Through Study Completion (Up to 6 Months)

Results and safety

Results posted to the registry on 23 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
300 mg LY3164530 Schedule 1	3	3
600 mg LY3164530 Schedule 1	3	2
1000 mg LY3164530 Schedule 1	11	7
1250 mg LY3164530 Schedule 1	3	1
500 mg LY3164530 Schedule 2	5	3
600 mg LY3164530 Schedule 2	4	2

Primary outcome: Recommended Phase 2 Dose of LY3164530: Maximum Tolerated Dose (MTD)

Time frame: Cycle 1 (Cycle = 28 days). Number. Unit: milligrams (mg)

Measure	Schedule 1 n = 20	Schedule 2 n = 9
Value	1000	500

Population analysed: All participants who receive at least one dose of study drug.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline Through Study Completion (Up to 6 Months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
300 mg LY3164530 Schedule 1	0 of 3 (0%)	3 of 3 (100%)	0 of 3
600 mg LY3164530 Schedule 1	1 of 3 (33.3%)	3 of 3 (100%)	1 of 3
1000 mg LY3164530 Schedule 1	3 of 11 (27.3%)	11 of 11 (100%)	0 of 11
1250 mg LY3164530 Schedule 1	0 of 3 (0%)	3 of 3 (100%)	0 of 3
500 mg LY3164530 Schedule 2	0 of 5 (0%)	5 of 5 (100%)	0 of 5
600 mg LY3164530 Schedule 2	0 of 4 (0%)	4 of 4 (100%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3164530 in people with Neoplasms and Neoplasm Metastasis, run by Eli Lilly and Company at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Phase 2 Dose of LY3164530: Maximum Tolerated Dose (MTD) (time frame: Cycle 1 (Cycle = 28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02221882.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.