LY4170156 for Breast Cancer

Recruiting at 15 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Eli Lilly and Company

Disqualifiers: CNS metastases, Carcinomatous meningitis, Infections, others

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to find out whether the study drug, LY4170156, is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Contact Lilly at 1-800-LillyRx (1-800-545-5979)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

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.

Inclusion Criteria

I have a specific type of cancer such as ovarian, endometrial, cervical, lung, breast, pancreatic, or colorectal.

Exclusion Criteria

I have had cancer spread to the lining of my brain and spinal cord.

I do not have any active, uncontrolled infections.

I have a serious heart condition.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a: Dose-escalation

Escalating doses of LY4170156 administered intravenously to determine the recommended phase 2 dose (RP2D)

12 weeks

4 cycles of 21 days each

Phase 1b: Dose-expansion

LY4170156 administered intravenously to assess antitumor activity

Up to 48 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LY4170156 (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: LY4170156 (Enrichment Cohort A3) Experimental Treatment 1 Intervention

Monotherapy administered IV

Group II: LY4170156 (Dose-optimization, Cohort A2) Experimental Treatment 1 Intervention

Comparing 2 or more doses (evaluated during dose escalation) of LY4170156 administered IV.

Group III: LY4170156 (Dose-expansion, Cohort B1, B2, C1, C2) Experimental Treatment 1 Intervention

LY4170156 administered IV.

Group IV: LY4170156 (Dose-escalation, Cohort A1) Experimental Treatment 1 Intervention

Escalating doses of LY4170156 administered intravenously (IV).

Group V: LY4170156 (Combination Cohort A5) Experimental Treatment 2 Interventions

Combination with carboplatin administered IV

Group VI: LY4170156 (Combination Cohort A4) Experimental Treatment 2 Interventions

Combination with bevacizumab administered IV

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Loxo Oncology, Inc.

Industry Sponsor

Trials

72

Recruited

11,600+

Jacob Van Naarden

Loxo Oncology, Inc.

Chief Executive Officer since 2019

A.B. in Molecular Biology from Princeton University

Dr. Jennifer Low

Loxo Oncology, Inc.

Chief Medical Officer since 2014

MD and PhD from Georgetown University; Undergraduate degree from California Institute of Technology