A Phase 1 Trial Investigating LY4101174, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Recurrent, Advanced or Metastatic Solid Tumors

Status: Recruiting
Location: See all (28) 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, LY4101174, is safe, tolerable and effective in participants with select advanced or metastatic solid tumors. 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 C1: triple negative breast cancer

⁃ Cohort C2: non-small cell lung cancer

⁃ Cohort C3: ovarian or fallopian tube cancer

⁃ Cohort C4: cervical cancer

⁃ Cohort C5: head and neck squamous cell carcinoma

• Prior Systemic Therapy Criteria:

‣ Cohort A1/C1-5: 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/C1-5: 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)

⁃ Cohorts A2, B1, B2, C1-5: measurable disease required 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
Florida
AdventHealth Orlando
RECRUITING
Orlando
Georgia
Emory University
RECRUITING
Atlanta
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Missouri
Washington University School of Medicine
RECRUITING
St Louis
New York
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
NOT_YET_RECRUITING
Mineola
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
RECRUITING
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
South Texas Accelerated Research Therapeutics (START)
RECRUITING
San Antonio
Other Locations
Australia
Austin Health
RECRUITING
Heidelberg
Icon Cancer Centre Kurralta Park
RECRUITING
Kurralta Park
Belgium
Institut Jules Bordet
RECRUITING
Anderlecht
China
Peking University First Hospital
NOT_YET_RECRUITING
Beijing
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
Shanghai East Hospital
NOT_YET_RECRUITING
Shanghai
France
Centre Oscar Lambret
RECRUITING
Lille
Centre Leon Berard
RECRUITING
Lyon
Institut Paoli-Calmettes
RECRUITING
Marseille
Institut de cancérologie Strasbourg Europe
RECRUITING
Strasbourg
Gustave Roussy
RECRUITING
Villejuif
Japan
National Cancer Center Hospital
RECRUITING
Chūōku
National Cancer Center Hospital East
RECRUITING
Kashiwa
The Cancer Institute Hospital of JFCR
RECRUITING
Kōtō City
Kyoto University Hospital
RECRUITING
Kyoto
Spain
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
MD Anderson Cancer Center
RECRUITING
Madrid
Hospital Universitario Virgen Del Rocio
RECRUITING
Seville
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: 2024-03-05
Estimated Completion Date: 2027-03
Participants
Target number of participants: 490
Treatments
Experimental: LY4101174 (Dose-escalation, Cohort A1)
Escalating doses of LY4101174 administered intravenously (IV).
Experimental: LY4101174 (Dose-optimization, Cohort A2)
Comparing 2 or more doses (evaluated during dose escalation) of LY4101174 administered IV.
Experimental: LY4101174 (Dose-expansion, Cohort B1, B2, C1-C5)
LY4101174 administered IV.
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov

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