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Monoclonal Antibodies
LY3321367 for Solid Tumors
Phase 1
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to objective progression or death due to any cause (estimated up to 12 months)
Awards & highlights
Study Summary
This trial is testing the safety of two drugs, LY3321367 and LY3300054, given to people with cancer that has come back or stopped responding to treatment.
Eligible Conditions
- Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to objective progression or death due to any cause (estimated up to 12 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to objective progression or death due to any cause (estimated up to 12 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with DLTs
Secondary outcome measures
DCR: Percentage of Participants who Exhibit SD, CR or PR
DoR
ORR: Percentage of Participants With a CR or PR
+4 moreTrial Design
7Treatment groups
Experimental Treatment
Group I: LY3321367 Dose ExpansionExperimental Treatment1 Intervention
LY3321367 given IV.
Group II: LY3321367 Dose EscalationExperimental Treatment1 Intervention
LY3321367 given intravenously (IV).
Group III: LY3321367 + LY3300054 Dose ExpansionExperimental Treatment2 Interventions
LY3321367 and LY3300054 given IV.
Group IV: LY3321367 + LY3300054 Dose EscalationExperimental Treatment2 Interventions
LY3321367 and LY3300054 given IV.
Group V: Japanese Arm F LY3321367 + LY3300054Experimental Treatment2 Interventions
LY3321367 and LY3300054 given IV.
Group VI: Japanese Arm E LY3300054Experimental Treatment1 Intervention
LY3300054 given IV.
Group VII: Japanese Arm D LY3321367Experimental Treatment1 Intervention
LY3321367 given IV.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3321367
2017
Completed Phase 1
~210
LY3300054
2017
Completed Phase 1
~230
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,615 Previous Clinical Trials
3,200,849 Total Patients Enrolled
Study DirectorEli Lilly and Company
1 Previous Clinical Trials
426 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a heart condition that is not mild.You have a blockage in your intestines or have had surgery to remove a large portion of your intestines.You can participate in Phase 1a and 1b if you have previously received PD-1 or PD-L1 therapy or other immunotherapy, as long as you meet certain conditions.You have tumors that have spread to your brain, spinal cord, or the covering of your brain (leptomeningeal disease) and require ongoing treatment such as surgery, radiation, or corticosteroids to manage symptoms. However, if you take anticonvulsant medications, you may still be eligible.
Research Study Groups:
This trial has the following groups:- Group 1: Japanese Arm F LY3321367 + LY3300054
- Group 2: Japanese Arm E LY3300054
- Group 3: LY3321367 Dose Escalation
- Group 4: LY3321367 Dose Expansion
- Group 5: LY3321367 + LY3300054 Dose Expansion
- Group 6: LY3321367 + LY3300054 Dose Escalation
- Group 7: Japanese Arm D LY3321367
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a presence of this investigation in North American hospitals?
"This clinical trial is available at 8 different medical sites, such as the Dana Farber Cancer Institute in Boston, Peggy and Charles Stephenson Oklahoma City Center for Cancer Care in Oklahoma City and The START Centre for Cancer Care in San Antonio."
Answered by AI
Has the FDA sanctioned LY3321367 for public use?
"Considering the limited data surrounding this drug's efficacy and safety, LY3321367 received a score of 1 on our team at Power's scale."
Answered by AI
Are there any vacancies for enrollment in this clinical experiment?
"The clinicaltrials.gov page for this medical trial indicates that it is not currently seeking participants, despite being initially posted on April 12th 2017 and most recently updated November 18th 2022. However, an abundance of other trials are available to join at the present moment with 2584 open studies accepting new patients."
Answered by AI
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