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Testing LY4101174 for advanced or metastatic solid tumors

A Phase 1 Trial Investigating LY4101174, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Recurrent, Advanced or Metastatic Solid Tumors

PHASE1 · Eli Lilly and Company · NCT06238479

This study is testing a new drug called LY4101174 to see if it can help people with advanced or metastatic solid tumors feel better and improve their treatment options.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment490 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company (industry)
Drugs / interventionsenfortumab
Locations25 sites (Orlando, Florida and 24 other locations)
Trial IDNCT06238479 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and effectiveness of the drug LY4101174 in patients with advanced or metastatic solid tumors. It consists of two phases: Phase 1a focuses on dose escalation and optimization to determine the recommended phase 2 dose, while Phase 1b assesses the drug's efficacy and safety at this optimal dose across various tumor types. The study aims to gather data over approximately four years to inform future treatment options for these patients.

Who should consider this trial

Good fit: Ideal candidates include individuals with specific types of advanced or metastatic solid tumors who have exhausted standard treatment options.

Not a fit: Patients with early-stage tumors or those who have not yet received standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with difficult-to-treat advanced or metastatic solid tumors.

How similar studies have performed: Other studies have shown promise with similar approaches in targeting advanced solid tumors, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion 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
* Individual with active uncontrolled infection

Where this trial is running

Orlando, Florida and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Metastatic Solid Tumor, Recurrent Solid Tumor, Advanced Solid Tumor, Urinary Bladder Neoplasm, Triple Negative Breast Cancer, Non-small Cell Lung Cancer, Esophageal Cancer, Pancreatic Cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.