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Monoclonal Antibodies

LY4101174 (Dose-escalation, Cohort A1) for Head and Neck Squamous Cell Carcinoma

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

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 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.Check my eligibility

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.See study design

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 below

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have one of the listed types of cancer.

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 more

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).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Loxo Oncology, Inc.Industry Sponsor

66 Previous Clinical Trials

9,589 Total Patients Enrolled

Eli Lilly and CompanyLead Sponsor

2,620 Previous Clinical Trials

3,216,319 Total Patients Enrolled

Xiaojian (Thomas) XuStudy DirectorLoxo Oncology, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing efforts to enroll participants for this research study?

"As per the details available on clinicaltrials.gov, recruitment for this research study is currently closed. The trial was first listed on February 29th, 2024, and last updated on January 26th, 2024. Despite its current inactive status in patient enrollment, there are approximately 6431 other ongoing studies actively seeking participants at present."

Answered by AI

What are the primary objectives of this medical study?

"The primary goal of this study, to be monitored for about 48 months or approximately 4 years, is Phase 1a: Establishing the optimal dose of LY4101174. Secondary objectives include assessing early antitumor effects such as Duration of Response (DOR) according to RECIST 1.1 criteria by investigators, Time to Response (TTR) also based on RECIST 1.1 assessment by investigators, and Progression-Free Survival (PFS) determined through investigator-assessed RECIST 1.1 evaluations."

Answered by AI

Has LY4101174 (Dose-optimization, Cohort A2) received clearance from the FDA for use?

"Given that this is a Phase 1 trial with minimal data backing its safety and efficacy, our evaluation at Power rates the safety of LY4101174 (Dose-optimization, Cohort A2) as a 1 on the scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors

2024. "A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06238479.

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