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

NCT06465069 | Recruiting Phase 1 DMC FDA Drug

• 4 other identifiers: 188822024-512927-36-00J5I-OX-JZYALOXO-LNC-24001
• Study Type: interventional
• Target: 420
• Locations: 8 countries
• Sites: 31

Brief Summary

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.

Conditions

Metastatic Solid Tumor; Esophageal Cancer; Pancreatic Cancer; Ovarian Cancer; Cervical Cancer; Head and Neck Squamous Cell Carcinoma; Prostate Cancer; Renal Pelvis Cancer; Bladder Cancer; Recurrent Solid Tumor; Advanced Solid Tumor; Urinary Bladder Neoplasm; Triple Negative Breast Cancer; Non-small Cell Lung Cancer

Keywords

Bladder Cancer; Bladder Neoplasm; Bladder Urothelial Carcinoma; Urinary Bladder Cancer; Urinary Tract Cancer; Urothelial Neoplasms; Renal Pelvis Cancer; Ureter Cancer; Nectin-4; Antibody Drug Conjugate (ADC); Triple Negative Breast Cancer (TNBC); Non-small Cell Lung Cancer (NSCLC); Head and Neck Squamous Cell Carcinoma (HNSCC)

Outcome Measures

Primary Outcomes (2)

• Phase 1a: To determine the recommended phase 2 dose (RP2D) optimal dose(s) of LY4052031

  Number of participants with dose-limiting toxicities (DLTs)

  Cycle 1 (21 Days)

• Phase 1b: To assess the antitumor activity of LY4052031 Monotherapy: Overall response rate (ORR)

  ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

  Up to Approximately 48 Months or 4 Years

Secondary Outcomes (8)

• To characterize the pharmacokinetics (PK) properties of LY4052031: Minimum Plasma Concentration (Cmin)

  Cycle 1 (21 Days)

• To characterize the PK properties of LY4052031: Area under the concentration versus time curve (AUC)

  Cycle 1 (21 Days)

• To evaluate the preliminary antitumor activity of LY4052031: Overall response rate (ORR)

  Up to Approximately 48 Months or 4 Years

• To evaluate the preliminary antitumor activity of LY4052031: Duration of response (DOR)

  Up to Approximately 48 Months or 4 Years

• To evaluate the preliminary antitumor activity of LY4052031: Time to response (TTR)

  Up to Approximately 48 Months or 4 Years

Study Arms (3)

LY4052031 (Dose-escalation, Cohort A1)

EXPERIMENTAL

Escalating doses of LY4052031 administered intravenously (IV).

Drug: LY4052031

LY4052031 (Dose-optimization, Cohort A2)

EXPERIMENTAL

Comparing 2 or more doses (evaluated during dose escalation) of LY4052031 administered IV.

Drug: LY4052031

LY4052031 (Dose-expansion, Cohort B1, B2, C1)

EXPERIMENTAL

LY4052031 administered IV.

Drug: LY4052031

Interventions

LY4052031 DRUG

Intravenous

LY4052031 (Dose-escalation, Cohort A1); LY4052031 (Dose-expansion, Cohort B1, B2, C1); LY4052031 (Dose-optimization, Cohort A2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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, 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 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

You may not qualify 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
• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (31)

City of Hope National Medical Center

Duarte, California, 91010-0269, United States

RECRUITING

Sarah Cannon Research Institute at HealthOne

Denver, Colorado, 80218, United States

RECRUITING

Florida Cancer Specialists and Research Institute

St. Petersburg, Florida, 33705, United States

RECRUITING

University of Chicago Hospital

Chicago, Illinois, 60637, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

RECRUITING

START Midwest Cancer and Hematology Centers of W Michigan

Grand Rapids, Michigan, 49546, United States

RECRUITING

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029-6574, United States

RECRUITING

Columbia University Irving Medical Center

New York, New York, 10032-3729, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030-4000, United States

RECRUITING

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, 78229, United States

RECRUITING

University of Utah - Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

RECRUITING

START Mountain Region

West Valley City, Utah, 84119, United States

RECRUITING

St Vincent's Hospital

Darlinghurst, 2010, Australia

RECRUITING

Linear Clinical Research

Nedlands, 6009, Australia

RECRUITING

Beijing Cancer hospital

Beijing, 100142, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, 510060, China

RECRUITING

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200000, China

NOT YET RECRUITING

Institut Gustave Roussy (Igr)

Villejuif, 94805, France

RECRUITING

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

RECRUITING

The Cancer Institute Hospital of JFCR

Kōtō City, 135-8550, Japan

RECRUITING

Aichi Cancer Center Hospital

Nagoya, 464-8681, Japan

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Catalan Institute of Oncology Duran i Reynals Hospital

Barcelona, 8908, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Madrid Norte Sanchinarro

Madrid, 28050, Spain

RECRUITING

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

RECRUITING

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

RECRUITING

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

Related Links

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

MeSH Terms

Conditions

Neoplasm Metastasis; Urinary Bladder Neoplasms; Triple Negative Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Esophageal Neoplasms; Pancreatic Neoplasms; Ovarian Neoplasms; Uterine Cervical Neoplasms; Squamous Cell Carcinoma of Head and Neck; Prostatic Neoplasms; Urologic Neoplasms; Ureteral Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Ureteral Diseases

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1); CN (3); ES (4); US (15); FR (1); AU (2); JP (3); GB (2)