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Monoclonal Antibodies

LY4170156 for Breast Cancer

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
Have one of the following solid tumor cancers: Cohort A1 - Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer, endometrial cancer, cervical cancer, non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), pancreatic, and colorectal cancer (CRC); Cohort A2/B1/B2 - Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer; Cohort C1/C2 - Endometrial cancer, cervical cancer, NSCLC, TNBC, CRC or pancreatic cancer
Be older than 18 years old
Must not have
Individual with known or suspected uncontrolled central nervous system (CNS) metastases
Individual with history of carcinomatous meningitis
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 LY4170156 to see if it is safe and effective for treating advanced solid tumors. The study will be done in two phases and will last about 4

Who is the study for?
This trial is for individuals with advanced solid tumors, including pancreatic, cervical, breast, colorectal cancer, endometrial cancer, non-small cell lung cancer and ovarian tumors. Specific eligibility criteria are not provided.
What is being tested?
The study tests LY4170156's safety and effectiveness in treating various advanced cancers. It has two parts: phase Ia to find the right dose and phase Ib to see how well it works at that dose over approximately four years.
What are the potential side effects?
Potential side effects of LY4170156 aren't detailed here but typically include reactions where the drug is administered, fatigue, nausea or other digestive issues based on similar treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a specific type of cancer such as ovarian, endometrial, cervical, lung, breast, pancreatic, or colorectal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have uncontrolled brain metastases.
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I have had cancer spread to the lining of my brain and spinal cord.
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I do not have any active, uncontrolled infections.
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I have had a corneal transplant or have been diagnosed with corneal keratopathy.
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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 a serious heart condition.
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I have had lung inflammation or scarring before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 48 months or 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 48 months or 4 years for reporting.

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 RP2D or optimal dose of LY4170156
Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY4170156
Phase 1b: To assess the antitumor activity of LY4170156 Monotherapy: Overall response rate (ORR)
Secondary study objectives
To characterize the PK properties of LY4170156: Area under the concentration versus time curve (AUC)
To characterize the pharmacokinetics (PK) properties of LY4170156: Minimum Plasma Concentration (Cmin)
To evaluate the preliminary antitumor activity of LY4170156: Disease control rate (DCR)
+4 more

Awards & 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: LY4170156 (Dose-optimization, Cohort A2)Experimental Treatment1 Intervention
Comparing 2 or more doses (evaluated during dose escalation) of LY4170156 administered IV.
Group II: LY4170156 (Dose-expansion, Cohort B1, B2, C1, C2)Experimental Treatment1 Intervention
LY4170156 administered IV.
Group III: LY4170156 (Dose-escalation, Cohort A1)Experimental Treatment1 Intervention
Escalating doses of LY4170156 administered intravenously (IV).

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,675 Previous Clinical Trials
3,463,763 Total Patients Enrolled
11 Trials studying Endometrial Cancer
1,132 Patients Enrolled for Endometrial Cancer
Loxo Oncology, Inc.Industry Sponsor
71 Previous Clinical Trials
10,840 Total Patients Enrolled
Emin AvsarStudy DirectorEli Lilly and Company
1 Previous Clinical Trials
110 Total Patients Enrolled
~147 spots leftby Feb 2027
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