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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 below

Select...

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

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 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 more

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).

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,624 Previous Clinical Trials

3,216,577 Total Patients Enrolled

Loxo Oncology, Inc.Industry Sponsor

67 Previous Clinical Trials

9,869 Total Patients Enrolled

Emin AvsarStudy DirectorLoxo Oncology, Inc.

1 Previous Clinical Trials

110 Total Patients Enrolled

Frequently Asked Questions

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

Are researchers currently seeking participants for this clinical trial?

"As per the details available on clinicaltrials.gov, this particular research endeavor is currently not in pursuit of new participants. It was first listed on May 1st, 2024, and last revised on the same day. Nevertheless, it's noteworthy that amidst a pool of 8382 ongoing trials, there are numerous opportunities for eligible individuals to participate in other studies."

Answered by AI

Has the FDA given their approval for LY4170156 (Dose-escalation, Cohort A1)?

"Given that this study is in Phase 1 and has scant evidence supporting its safety and effectiveness, LY4170156 (Dose-escalation, Cohort A1) received a safety rating of 1 from our team at Power."

Answered by AI

Could you please outline the main goals of this medical study?

"The core aim of this clinical investigation, which spans an estimated period of up to approximately 48 months equating to a duration of about 4 years, is Phase 1a: To ascertain the Recommended Phase 2 Dose (RP2D) or most effective dosage level for LY4170156. Additional objectives entail assessing the initial anti-tumor effects of LY4170156 through parameters such as Overall Response Rate (ORR), defined according to Investigator-Assessed Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); examining its preliminary impact on tumor regression via metrics like Duration of"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

2024. "A Study of LY4170156 in Participants With Selected Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06400472.

All > Non Small Cell Lung Cancer > Endometrial Cancer