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New treatment option for Metastatic Solid Tumor
Official title A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
ClinicalTrials.gov ID: NCT06465069
What this study is testing
What is LY4052031?
LY4052031 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Cohort A2/B1/B2: urothelial carcinoma
- Cohort C: triple negative breast cancer, non-small cell lung cancer, ovarian cancer, cervical cancer, HNSCC (head and neck squamous cell carcinoma)...
- Prior Systemic Therapy Criteria:
You likely can't join if
- Individual with known or suspected uncontrolled CNS metastases
- Individual with uncontrolled hypercalcemia
- Individual with uncontrolled diabetes
- Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant
- Any serious unresolved toxicities from prior therapy
- Significant cardiovascular disease
See the full eligibility 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...
- Cohort A2/B1/B2: urothelial carcinoma
- Cohort C: triple negative breast cancer, non-small cell lung cancer, ovarian cancer, cervical cancer, HNSCC (head and neck squamous cell carcinoma), esophageal cancer, pancreatic cancer, or prostate cancer
- Prior Systemic Therapy Criteria:
- Cohort A1/C: 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...
- 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/C: 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)
- Measurable disease is required as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for all Cohorts. Cohort A1 may permit non-measurable disease 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
- Individual with known or suspected uncontrolled CNS metastases
- Individual with uncontrolled hypercalcemia
- Individual with uncontrolled diabetes
- Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant
- Any serious unresolved toxicities from prior therapy
- Significant cardiovascular disease
- Recent thromboembolic event and/or clinically significant 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
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Denver, Colorado, United States
- St. Petersburg, Florida, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Salt Lake City, Utah, United States
- West Valley City, Utah, United States
- Darlinghurst, Australia
- Nedlands, Australia
- Beijing, China
+ 13 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; La Jolla, California, United States; Los Angeles, California, United States; Denver, Colorado, United States; St. Petersburg, Florida, United States; Chicago, Illinois, United States and 27 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.