Oncology Cardiology / Cardiovascular Respiratory / COPD / Asthma Infectious Disease Gastroenterology Neurology Rheumatology Diabetes / Metabolic Mental Health / Psychiatry Women's Health Dermatology Men's Health Rare Diseases
Clinical Trial ● Currently Recruiting Phase I NCT06465069

A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors

A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors — Recruiting • Phase I • Oncology • NCT06465069.

📅 25 Mar 2026 ⏱ 2 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase I
NCT ID
NCT06465069
Sponsor
Eli Lilly and Company
Start
2024-07-01
ClinicaliQ Trial Snapshot
  • A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors — Recruiting • Phase I • Oncology • NCT06465069.
  • 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)….
  • Sponsor: Eli Lilly and Company.

Verify eligibility, endpoints and current status on the original source registry before acting on this summary.

Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

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.

Eligibility Snapshot
  • : * 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 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. 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/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…

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
View Trial ↗
Share: Twitter/X LinkedIn
Related

Related Clinical Intelligence

Guidelines, Drug Science, safety briefs and education connected to this trial area.

Guideline
Nivolumab with chemotherapy for untreated unresectable or metastatic urothelial cancer (terminated appraisal)
Oncology · 17 Mar 2026
I appreciate your request, but I need to be transparent: the content provided only includes the title, metadata, and editorial notes -…
View guideline →
Guideline
Head and Neck Cancers: Diagnosis and Management (NICE NG36)
Oncology · 27 Mar 2026
Refer urgently (two-week wait) any adult with unexplained persistent hoarseness, dysphagia, otalgia, oral ulceration lasting more than 3 weeks, or suspicious neck…
View guideline →
Guideline
2023 ESMO Clinical Practice Guidelines: Metastatic Non-Small Cell Lung Cancer
Oncology · 30 Mar 2026
Covers diagnostic workup and molecular profiling for metastatic non-small cell lung cancer (NSCLC) • Provides treatment algorithms based on biomarker status (EGFR,…
View guideline →
Guideline
Bladder Cancer: Diagnosis and Management (NICE NG2)
Oncology · 27 Mar 2026
Blue light cystoscopy with hexaminolevinate improves detection of recurrent bladder tumours compared to white light cystoscopy alone, particularly for carcinoma in situ.…
View guideline →
Guideline
Pembrolizumab for neoadjuvant and adjuvant treatment of resectable locally advanced head and neck squamous cell carcinoma
Oncology · 21 Apr 2026
Pembrolizumab is recommended as neoadjuvant treatment prior to surgery for resectable locally advanced head and neck squamous cell carcinoma, followed by adjuvant…
View guideline →
Clinical Brief
11 cancers on the rise in young people – scientists find first clue why it’s happening
Oncology · BBC Health · 28 Apr 2026
Early-onset cancers are increasing across 11 cancer types in younger populations, representing a clinically significant epidemiological shift requiring increased diagnostic vigilance Scientists…
View brief →