At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- LY4052031 (drug)
- How long the study runs
- Study runs about 34 months (dates as stated)
- About the drug or intervention
- LY4052031 — drug: Intravenous
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 420
- Started
- 2024-07-01
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for metastatic solid tumor
- • Phase1 - 420 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with metastatic solid tumor
Where?
- • London - St Bartholomew's Hospital
- • Manchester - The Christie NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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). The study will last up to approximately 4 years.
More detail
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 evaluates an antibody-drug conjugate that binds to the protein nectin-4, which is expressed on certain cancer cells, delivering the drug to the cancer. 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 LY4052031 to determine the recommended phase 2 dose (RP2D)/optimal dose. Phase 1b will evaluate efficacy and safety of LY4052031 at the RP2D/optimal dose in expansion cohorts based on tumor type and/or treatment history.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ received at least one prior regimen in the advanced or metastatic setting
- ✓ in the advanced
- ✓ enf
- ✓ received enfortumab vedotin in the metastatic/advanced setting
What the study is looking for
- ✓Have one of the following solid tumor cancers:
- ✓Cohort A2/B1/B2: urothelial carcinoma
- ✓Prior treatment that goes through your whole body Criteria:
- ✓Cohort A2/B1/B2: Individual must have received at least one prior regimen in the advanced or that has spread setting....
- ✓Prior enfortumab vedotin specific requirements:
Who cannot take part
- ✗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
See the full criteria
Where Is This Study? (2 UK sites)
St Bartholomew's Hospital
London EC1A 7BE, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
How to Get in Touch
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Sponsor contactCONTACT
Physicians interested in becoming principal investigators please contact
Sponsor contactCONTACT
