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A Study of LY3435151 in Participants With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099277
Recruitment Status : Terminated (Study terminated due to strategic business decision by Eli Lilly and Company.)
First Posted : September 23, 2019
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The reason for this study is to see if the study drug LY3435151 is safe in participants with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumor Triple-negative Breast Cancer Gastric Adenocarcinoma Head and Neck Squamous Cell Carcinoma Cervical Carcinoma High Grade Serous Ovarian Carcinoma Hepatocellular Carcinoma Undifferentiated Pleomorphic Sarcoma Leiomyosarcoma Drug: LY3435151 Drug: Pembrolizumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1a/1b Study of LY3435151 Administered to Patients With Advanced Solid Tumors
Actual Study Start Date : October 28, 2019
Actual Primary Completion Date : March 5, 2020
Actual Study Completion Date : March 5, 2020


Arm Intervention/treatment
Experimental: LY3435151 Dose Escalation
LY3435151 administered intravenously (IV).
Drug: LY3435151
Administered IV

Experimental: LY3435151 + Pembrolizumab Dose Escalation
LY3435151 and Pembrolizumab administered IV.
Drug: LY3435151
Administered IV

Drug: Pembrolizumab
Administered IV

Experimental: LY3435151 Dose Expansion
LY3435151 administered IV.
Drug: LY3435151
Administered IV

Experimental: LY3435151 + Pembrolizumab Dose Expansion
LY3435151 and Pembrolizumab administered IV.
Drug: LY3435151
Administered IV

Drug: Pembrolizumab
Administered IV




Primary Outcome Measures :
  1. Number of Participants with LY3435151 Dose-Limiting Toxicities (DLTs) [ Time Frame: Baseline through Cycle 2 (21 Day Cycles) ]
    Number of Participants with LY3435151 DLTs


Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3435151 [ Time Frame: Predose Cycle 1 Day 1 through Predose Cycle 5 Day 1 (21 Day Cycles) ]
    PK: Cmax of LY3435151

  2. PK: Cmax of LY3435151 in Combination with Pembrolizumab [ Time Frame: Predose Cycle 1 Day 1 through Predose Cycle 5 Day 1 (21 Day Cycles) ]
    PK: Cmax of LY3435151 in Combination with Pembrolizumab

  3. Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline through Disease Progression or Death (Estimated up to 12 Months) ]
    ORR: Percentage of Participants with CR or PR

  4. Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and Stable Disease [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 12 Months) ]
    DCR: Percentage of Participants with a Best Overall Response of CR, PR, and Stable Disease

  5. Duration of Response (DoR) [ Time Frame: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 12 Months) ]
    DoR

  6. Time to Response (TTR) [ Time Frame: Baseline to Date of CR or PR (Estimated up to 12 Months) ]
    TTR

  7. Progression Free Survival (PFS) [ Time Frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 12 Months) ]
    PFS



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant must have certain types of cancer, which your study doctor will discuss with you
  • Participant must have stopped other forms of treatment for cancer, which your study doctor will discuss with you
  • Participant must be able and willing to provide a sample of your tumor before beginning treatment and once while on treatment. For certain tumor types, the outcome of the biopsy may exclude you from the study treatment (for Phase 1b)
  • Participant must agree to use birth control
  • Participant must have progressed through or are intolerant to therapies with known clinical benefit, which your study doctor will discuss with you

Exclusion Criteria:

  • Participant must not have a history of tuberculosis, uncontrolled HIV or uncontrolled hepatitis B or C virus infection
  • Participant must not have an autoimmune disease, which your study doctor will discuss with you
  • Participant must not use corticosteroids, which your study doctor will discuss with you
  • Participant must not have heart disease, Crohn's disease or brain cancer
  • Participant must not be pregnant or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099277


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Japan
National Cancer Center Hospital
Chuo-Ku, Tokyo, Japan, 104-0045
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04099277    
Other Study ID Numbers: 17364
J1Q-MC-JZIA ( Other Identifier: Eli Lilly and Company )
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
immunotherapy
CD226 agonist
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Triple Negative Breast Neoplasms
Squamous Cell Carcinoma of Head and Neck
Leiomyosarcoma
Histiocytoma, Malignant Fibrous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Squamous Cell
Adenocarcinoma
Sarcoma
Neoplasms, Connective and Soft Tissue
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Breast Neoplasms
Breast Diseases
Skin Diseases
Head and Neck Neoplasms
Neoplasms, Muscle Tissue
Histiocytoma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents