Esophageal Cancer Clinical Trial

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

Summary

The purpose of this study is to find out whether the study drug, LY4101174, is safe, tolerable and effective in participants with advanced, or metastatic 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.

View Full Description

Full Description

This is a Phase 1a/1b multicenter, open-label study in participants with advanced or metastatic solid tumor malignancies known to express Nectin 4. This study is comprised of two phases: Dose Escalation and Dose Optimization (1a), and Dose expansion (1b). Phase 1a will assess the safety, tolerability, and pharmacokinetics of LY4101174 to determine the recommended phase 2 dose (RP2D)/optimal dose. Phase 1b will evaluate efficacy and safety of LY4101174 at the RP2D/optimal dose in 7 expansion cohorts based on tumor type and/or treatment history.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Have one of the following solid tumor cancers:

Cohort A1: 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
Cohort A2/B1/B2: urothelial carcinoma
Cohort C1: triple negative breast cancer
Cohort C2: non-small cell lung cancer
Cohort C3: ovarian or fallopian tube cancer
Cohort C4: cervical cancer
Cohort C5: head and neck squamous cell carcinoma

Prior Systemic Therapy Criteria:

Cohort A1/C1-5: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies
Cohort A2/B1/B2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies.

Prior enfortumab vedotin specific requirements:

Cohorts A1/A2/C1-5: prior treatment with enfortumab vedotin is allowed, but not required
Cohort B1: individual must be enfortumab vedotin naive in the advanced/metastatic setting
Cohort B2: individual must have received enfortumab vedotin in the metastatic/advanced setting.

Measurability of disease

Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)

Cohorts A2, B1, B2, C1-5: measurable disease required as defined by RECIST v1.1

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations

Exclusion Criteria:

Individual with known or suspected uncontrolled CNS metastases
Individual with uncontrolled hypercalcemia
Individual with uncontrolled diabetes
Individual with evidence of corneal keratopathy or history of corneal transplant
Any serious unresolved toxicities from prior therapy
Significant cardiovascular disease
Current of history of intestinal obstruction in the previous 3 months
Recent thromboembolic event or bleeding disorder
Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms
History of pneumonitis/interstitial lung disease
History of Grade ≥3 skin toxicity when receiving enfortumab vedotin
Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

280

Study ID:

NCT06238479

Recruitment Status:

Recruiting

Sponsor:

Eli Lilly and Company

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 7 Locations for this study

See Locations Near You

Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
New York University Medical Center
New York New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
University of North Carolina Medical Center
Chapel Hill North Carolina, 27599, United States
UT Southwestern Medical Center
Dallas Texas, 75390, United States
South Texas Accelerated Research Therapeutics (START)
San Antonio Texas, 78229, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

280

Study ID:

NCT06238479

Recruitment Status:

Recruiting

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.