Metastatic Solid TumorRecurrent Solid TumorAdvanced Solid TumorUrinary Bladder NeoplasmTriple Negative Breast CancerNon-small Cell Lung CancerEsophageal CancerPancreatic CancerOvarian CancerCervical CancerHead and Neck Squamous Cell CarcinomaProstate CancerRenal Pelvis CancerBladder Cancer
Investigational drug(s) / intervention(s)
LY4052031
LY4052031: Intravenous
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 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
* 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 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
Primary outcome measure(s)
Phase 1a: To determine the recommended phase 2 dose (RP2D) optimal dose(s) of LY4052031 — Cycle 1 (21 Days) Number of participants with dose-limiting toxicities (DLTs)
Phase 1b: To assess the antitumor activity of LY4052031 Monotherapy: Overall response rate (ORR) — Up to Approximately 48 Months or 4 Years ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Trial sites (39)
Facility
City
Region
Status
City of Hope National Medical Center
Duarte
California
Recruiting
University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla
California
Not Yet Recruiting
UCLA Department of Medicine-Hematology/Oncology
Los Angeles
California
Recruiting
Sarah Cannon Research Institute at HealthOne
Denver
Colorado
Recruiting
Florida Cancer Specialists and Research Institute
St. Petersburg
Florida
Completed
University of Chicago Hospital
Chicago
Illinois
Recruiting
IU Simon Cancer Center
Indianapolis
Indiana
Not Yet Recruiting
Massachusetts General Hospital
Boston
Massachusetts
Recruiting
START Midwest Cancer and Hematology Centers of W Michigan
Grand Rapids
Michigan
Recruiting
Washington University School of Medicine in St. Louis
St Louis
Missouri
Recruiting
NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)
New York
New York
Recruiting
NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)
New York
New York
Not Yet Recruiting
Icahn School of Medicine at Mount Sinai
New York
New York
Recruiting
Columbia University Irving Medical Center
New York
New York
Recruiting
Memorial Sloan Kettering Cancer Center
New York
New York
Recruiting
University Hospitals Cleveland Medical Center
Cleveland
Ohio
Recruiting
Sarah Cannon Research Institute
Nashville
Tennessee
Recruiting
Tennessee Oncology PLLC
Nashville
Tennessee
Not Yet Recruiting
University of Texas MD Anderson Cancer Center
Houston
Texas
Recruiting
South Texas Accelerated Research Therapeutics (START)
San Antonio
Texas
Recruiting
University of Utah - Huntsman Cancer Institute
Salt Lake City
Utah
Recruiting
START Mountain Region
West Valley City
Utah
Recruiting
St Vincent's Hospital
Darlinghurst
Australia
Recruiting
Linear Clinical Research
Nedlands
Australia
Recruiting
Beijing Cancer hospital
Beijing
China
Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
China
Recruiting
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
China
Recruiting
Institut Gustave Roussy (Igr)
Villejuif
France
Recruiting
National Cancer Center Hospital
Chūōku
Japan
Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba
Japan
Recruiting
The Cancer Institute Hospital of JFCR
Kōtō City
Japan
Recruiting
Aichi Cancer Center Hospital
Nagoya
Japan
Recruiting
Asan Medical Center
Seoul
South Korea
Recruiting
Catalan Institute of Oncology Duran i Reynals Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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