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A Study of LY3415244 in Participants With Advanced 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: NCT03752177
Recruitment Status : Terminated (The study was terminated during dose escalation after a determination was made that the risk:benefit ratio no longer favored continued evaluation.)
First Posted : November 23, 2018
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The goal of this study is to evaluate the safety of LY3415244, a PD-L1/TIM-3 bispecific antibody, administered as monotherapy to participants with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: LY3415244 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1a/1b Study of LY3415244, a Bispecific Antibody in Patients With Advanced Solid Tumors
Actual Study Start Date : November 22, 2018
Actual Primary Completion Date : October 9, 2019
Actual Study Completion Date : October 9, 2019

Arm Intervention/treatment
Experimental: LY3415244 Dose Escalation
LY3415244 administered intravenously (IV).
Drug: LY3415244
Administered IV

Experimental: LY3415244 Dose Expansion
LY3415244 administered IV.
Drug: LY3415244
Administered IV




Primary Outcome Measures :
  1. Number of Participants with LY3415244 Dose-Limiting Toxicities (DLTs) [ Time Frame: Baseline through Cycle 1 (28 Day Cycle) ]
    Number of participants with LY3415244 DLTs


Secondary Outcome Measures :
  1. PK: Minimum Concentration (Cmin) of LY3415244 [ Time Frame: Predose Cycle 1 Day 1 (28 Day Cycle) through Follow up (Estimated up to 6 Months) ]
    PK: Cmin of LY3415244

  2. Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 24 Months) ]
    ORR: Percentage of participants who achieve CR or PR

  3. 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 24 Months) ]
    DoR

  4. Time to Response (TTR) [ Time Frame: Baseline to Date of CR or PR (Estimated up to 24 Months) ]
    TTR

  5. 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 24 Months) ]
    DCR: Percentage of participants with a best overall response of CR, PR, and stable disease

  6. Progression Free Survival (PFS) [ Time Frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 24 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:

  • For Phase 1a/b, histologic or cytologic confirmation of advanced solid tumor.
  • For Phase 1a/b, biopsy of tumor samples are required. Newly obtained core or excisional biopsy of a tumor lesion prior to study enrollment and undergo a biopsy procedure during the study.
  • Phase 1a, prior anti-PD-1 or anti-PD-L1 therapy or other immunotherapy is allowed.
  • Phase 1b, prior anti-PD-1 or anti-PD-L1 therapy is required where anti-PD-1 or anti-PD-L1 is standard of care in respective tumor types if the following criteria are met:

    • Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy
    • Must have completely recovered to baseline level prior to screening from any adverse events (AEs) that occurred from receiving prior immunotherapy
    • Must not have experienced a Grade ≥3 immune-related AE or immune related neurologic or ocular AE, pneumonitis or cardiomyopathy of any grade while receiving prior immunotherapy
    • Must not have required immunosuppressive agent, other than corticosteroids for the management of an adverse event and not currently require maintenance doses of >10 milligrams (mg) prednisone (or equivalent) per day
  • Must have at least 1 measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
  • Have adequate organ function.
  • Have an estimated life expectancy ≥12 weeks, in the judgement of the investigator.

Exclusion Criteria:

  • Have symptomatic central nervous system (CNS) malignancy or metastasis not requiring concurrent treatment, including but not limited to surgery, radiation, corticosteroids and/or anticonvulsants to treat CNS metastases, and their disease is asymptomatic and radiographically stable for at least 30 days.
  • Have received a live vaccine within 30 days before the first dose of study treatment.
  • If female, is pregnant, breastfeeding, or planning to become pregnant.
  • Have a history or current evidence of any condition, therapy, or laboratory abnormality that might interfere with the participant's participation.
  • Have moderate or severe cardiovascular disease.
  • Have a serious concomitant systemic disorder that would compromise the participant's ability to adhere to the protocol, including known infection with human immunodeficiency virus (HIV), active hepatitis B virus (HBV), active hepatitis C virus (HCV), active autoimmune disorders, or prior documented severe autoimmune or inflammatory disorders requiring immunosuppressive treatment.
  • Use of escalating or chronic supraphysiologic doses of corticosteroids or immunosuppressive agents (such as, cyclosporine). [Use of topical, ophthalmic, inhaled, and intranasal corticosteroids permitted].
  • Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection.
  • Evidence of interstitial lung disease or noninfectious pneumonitis.

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): NCT03752177


Locations
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United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Belgium
Institut Jules Bordet
Brussel, Belgium, 1000
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277 8577
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: NCT03752177    
Other Study ID Numbers: 17099
J1C-MC-JZDA ( Other Identifier: Eli Lilly and Company )
2018-001598-25 ( EudraCT Number )
First Posted: November 23, 2018    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
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:
TIM-3
PD-L1
Additional relevant MeSH terms:
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Neoplasms