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Monoclonal Antibodies
LY4101174 for Solid Tumors
Phase 1
Recruiting
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
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Patients must have one of the following solid tumor cancers: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma, or prostate cancer
Must not have
Individuals with history of Grade ≥3 skin toxicity when receiving enfortumab vedotin
Individuals with uncontrolled diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 48 months or 4 years
Awards & highlights
No Placebo-Only Group
Summary
"This trial is testing a new drug called LY4101174 to see if it is safe and effective for people with advanced solid tumors. The trial has two parts and will take about 4 years to
Who is the study for?
This trial is for people with advanced or metastatic solid tumors, including various types of cancer such as oral, pancreatic, ovarian, cervical, and more. Participants should have recurrent disease that has progressed despite treatment.
What is being tested?
The study is testing LY4101174 to assess its safety and effectiveness in treating different advanced solid tumors. It's structured in two phases: the first finds the right dose and the second expands to more patients at this dose over approximately 4 years.
What are the potential side effects?
Specific side effects of LY4101174 are not listed but may include typical reactions seen with cancer treatments such as nausea, fatigue, skin reactions, blood count changes or other organ-specific issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have one of the listed types of cancer.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had severe skin reactions from enfortumab vedotin treatment.
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My diabetes is not under control.
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I have had issues with my cornea or a cornea transplant.
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I have had a recent clotting event or bleeding disorder.
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I have had pneumonitis or interstitial lung disease in the past.
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I have a serious heart condition.
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I do not have uncontrolled brain metastases.
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I have high calcium levels in my blood that aren't managed.
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I don't have any serious side effects from past treatments that haven't gone away.
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I have had an intestinal blockage in the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 48 months or 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 48 months or 4 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase 1a: To determine the recommended dose of LY4101174
Phase 1a: To determine the recommended phase 2 dose (RP2D) or optimal dose of LY4101174
Phase 1b: To assess the antitumor activity of LY4101174 Monotherapy: Overall response rate (ORR)
Secondary study objectives
To characterize the PK properties of LY4101174: Area under the concentration versus time curve (AUC)
To characterize the pharmacokinetics (PK) properties of LY4101174: Minimum Plasma Concentration (Cmin)
To evaluate the preliminary antitumor activity of LY4101174: Disease control rate (DCR)
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: LY4101174 (Dose-optimization, Cohort A2)Experimental Treatment1 Intervention
Comparing 2 or more doses (evaluated during dose escalation) of LY4101174 administered IV.
Group II: LY4101174 (Dose-expansion, Cohort B1, B2, C1-C5))Experimental Treatment1 Intervention
LY4101174 administered IV.
Group III: LY4101174 (Dose-escalation, Cohort A1)Experimental Treatment1 Intervention
Escalating doses of LY4101174 administered intravenously (IV).
Find a Location
Who is running the clinical trial?
Loxo Oncology, Inc.Industry Sponsor
71 Previous Clinical Trials
10,780 Total Patients Enrolled
Eli Lilly and CompanyLead Sponsor
2,680 Previous Clinical Trials
3,466,104 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,391 Previous Clinical Trials
428,561 Total Patients Enrolled
Xiaojian (Thomas) XuStudy DirectorLoxo Oncology, Inc.