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Monoclonal Antibodies
LY4170156 (Dose-escalation, Cohort A1) for Cervical 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 48 months or 4 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have a specific type of cancer such as ovarian, endometrial, cervical, lung, breast, pancreatic, or colorectal.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreTrial 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).
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Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,627 Previous Clinical Trials
3,217,583 Total Patients Enrolled
Loxo Oncology, Inc.Industry Sponsor
67 Previous Clinical Trials
9,969 Total Patients Enrolled
Emin AvsarStudy DirectorLoxo Oncology, Inc.
1 Previous Clinical Trials
110 Total Patients Enrolled
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