A Phase 1a/1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors

Status: Recruiting
Location: See all (26) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
City of Hope National Medical Center
RECRUITING
Duarte
Colorado
Sarah Cannon Research Institute at HealthOne
RECRUITING
Denver
Florida
Florida Cancer Specialists and Research Institute
RECRUITING
St. Petersburg
Illinois
University of Chicago Hospital
RECRUITING
Chicago
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Michigan
START Midwest Cancer and Hematology Centers of W Michigan
RECRUITING
Grand Rapids
New York
Columbia University Irving Medical Center
RECRUITING
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Tennessee
Sarah Cannon Research Institute
RECRUITING
Nashville
Texas
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
South Texas Accelerated Research Therapeutics (START)
RECRUITING
San Antonio
Utah
University of Utah - Huntsman Cancer Institute
RECRUITING
Salt Lake City
START Mountain Region
RECRUITING
West Valley City
Other Locations
Australia
St Vincent's Hospital
RECRUITING
Darlinghurst
Linear Clinical Research
RECRUITING
Nedlands
France
Institut Gustave Roussy (Igr)
RECRUITING
Villejuif
Japan
The Cancer Institute Hospital of JFCR
RECRUITING
Kōtō City
Aichi Cancer Center Hospital
RECRUITING
Nagoya
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Spain
Catalan Institute of Oncology Duran i Reynals Hospital
RECRUITING
Barcelona
Hospital Madrid Norte Sanchinarro
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Virgen Del Rocio
RECRUITING
Seville
United Kingdom
St Bartholomew's Hospital
RECRUITING
London
The Christie NHS Foundation Trust
RECRUITING
Manchester
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2027-05
Participants
Target number of participants: 420
Treatments
Experimental: LY4052031 (Dose-escalation, Cohort A1)
Escalating doses of LY4052031 administered intravenously (IV).
Experimental: LY4052031 (Dose-optimization, Cohort A2)
Comparing 2 or more doses (evaluated during dose escalation) of LY4052031 administered IV.
Experimental: LY4052031 (Dose-expansion, Cohort B1, B2, C1)
LY4052031 administered IV.
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov

Similar Clinical Trials