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A Study of LY3415244 in Participants With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT03752177
Recruitment Status : Recruiting
First Posted : November 22, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The goal of this study is to evaluate the safety of LY3415244 administered as monotherapy to participants with advanced solid tumors.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 117 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
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020

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

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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 or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids (participants receiving anticonvulsants are eligible).
  • 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 active or chronic 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


Contacts
Contact: There may be multiple sites in this clinial trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com

Locations
United States, Massachusetts
Dana Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact    617-632-5055      
Principal Investigator: Hodi Stephen         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact    6468884863      
Principal Investigator: Matthew David Hellmann         
Belgium
Institut Jules Bordet Not yet recruiting
Brussel, Belgium, 1000
Contact    3225413189      
Principal Investigator: Philippe Aftimos         
Universitair Ziekenhuis Gent Not yet recruiting
Gent, Belgium, 9000
Contact    3293322692      
Principal Investigator: Sylvie Rottey         
Japan
National Cancer Center Hospital East Recruiting
Kashiwa, Chiba, Japan, 277 8577
Contact    81120360605      
Principal Investigator: Toshihiko Doi         
National Cancer Center Hospital Recruiting
Chuo-Ku, Tokyo, Japan, 104-0045
Contact    81120360605      
Principal Investigator: Toshio Shimizu         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03752177     History of Changes
Other Study ID Numbers: 17099
J1C-MC-JZDA ( Other Identifier: Eli Lilly and Company )
2018-001598-25 ( EudraCT Number )
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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