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A Study of LY3321367 Alone or With LY3300054 in Participants With Advanced Relapsed/Refractory Solid Tumors

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ClinicalTrials.gov Identifier: NCT03099109
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to evaluate the safety of the study drug known as LY3321367, an anti-T-cell immunoglobulin and mucin-domain domain-containing molecule-3 (TIM-3) antibody administered alone or in combination with LY3300054, an anti-programmed death ligand 1 (PD-L1) antibody, in participants with advanced relapsed/refractory solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: LY3321367 Drug: LY3300054 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1a/1b Study of LY3321367, an Anti-TIM-3 Antibody, Administered Alone or in Combination With LY3300054, an Anti-PD-L1 Antibody, in Advanced Relapsed/Refractory Solid Tumors
Actual Study Start Date : April 12, 2017
Estimated Primary Completion Date : June 14, 2020
Estimated Study Completion Date : June 14, 2020

Arm Intervention/treatment
Experimental: LY3321367 Dose Escalation
LY3321367 given intravenously (IV).
Drug: LY3321367
Administered IV

Experimental: LY3321367 + LY3300054 Dose Escalation
LY3321367 and LY3300054 given IV.
Drug: LY3321367
Administered IV

Drug: LY3300054
Administered IV

Experimental: LY3321367 Dose Expansion
LY3321367 given IV.
Drug: LY3321367
Administered IV

Experimental: LY3321367 + LY3300054 Dose Expansion
LY3321367 and LY3300054 given IV.
Drug: LY3321367
Administered IV

Drug: LY3300054
Administered IV

Experimental: Japanese Arm D LY3321367
LY3321367 given IV.
Drug: LY3321367
Administered IV

Experimental: Japanese Arm E LY3300054
LY3300054 given IV.
Drug: LY3300054
Administered IV

Experimental: Japanese Arm F LY3321367 + LY3300054
LY3321367 and LY3300054 given IV.
Drug: LY3321367
Administered IV

Drug: LY3300054
Administered IV




Primary Outcome Measures :
  1. Number of Participants with DLTs [ Time Frame: Baseline through Cycle 1 (28 Day Cycle) ]
    Dose Limiting Toxicity (DLT) is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possibly related to study drug.


Secondary Outcome Measures :
  1. PK: Cmax of LY3321367 [ Time Frame: Cycle 1 Day 1 through Follow-Up (Estimated up to 6 Months) ]
    Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3321367

  2. PK: Cmax of LY3321367 in Combination with LY3300054 [ Time Frame: Cycle 1 Day 1 through Follow-Up (Estimated up to 6 Months) ]
    Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3321367 in Combination with LY3300054

  3. ORR: Percentage of Participants With a CR or PR [ Time Frame: Baseline to Measured Progressive Disease (Estimated up to 6 Months) ]
    Objective Response Rate (ORR) is the percentage of participants with confirmed best overall tumor response of Complete Response (CR) or Partial Response (PR).

  4. PFS [ Time Frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 12 Months) ]
    Progression Free Survival (PFS) is defined as the date of the first dose to the first date of objectively determined progressive disease or death from any cause, whichever is earlier.

  5. DoR [ Time Frame: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months) ]
    Duration of Response (DoR) is defined as the time from the date of the first CR or PR to the first date of progressive disease (PD) or death from any cause.

  6. TTR [ Time Frame: Baseline to Date of CR or PR (Estimated up to 6 Months) ]
    Time to Response (TTR) is defined as time from treatment start to first documentation of response.

  7. DCR: Percentage of Participants who Exhibit SD, CR or PR [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 6 Months) ]
    Disease Control Rate (DCR) is the percentage of participants with stable disease (SD), confirmed PR or confirmed CR (CR+PR+SD).



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 Ph1a monotherapy and combination cohorts, histologic or cytologic confirmation of advanced solid tumor.
  • For Phase 1a and 1b, prior PD-1 or PD-L1 therapy or other immunotherapy is allowed, if the following criteria are met:

    • Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
    • Must have completely recovered or recovered to baseline prior to screening from any prior AEs occurring while receiving prior immunotherapy.
    • Must not have experienced a Grade ≥3 immune-related AE or an immune-related neurologic or ocular AE, pneumonitis or cardiomyopathy of any grade while receiving prior immunotherapy.
    • Must not have required immunosuppressive agents, other than corticosteroids for the management of an adverse event and not currently requite maintenance doses of >10 milligrams (mg) prednisone (or equivalent) per day.
  • Must have at least 1 measurable lesion assessable using standard techniques by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
  • Must have provided tumor tissue sample, as follows:

    • For participants entering Ph1a: have submitted, if available, an archival tumor tissue sample.
    • For participants entering Ph1b: have submitted, a sample from a newly obtained core or excisional biopsy of a tumor lesion or a recent biopsy defined by 6 months of study enrollment (Ph1b).
  • Must have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Must have adequate organ function.
  • Have an estimated life expectancy of 12 weeks, in 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): NCT03099109


Contacts
Contact: There may be multiple sites in this clinical 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 Recruiting
Boston, Massachusetts, United States, 02215
Contact    617-632-4292      
Principal Investigator: Geoffrey I Shapiro         
United States, New York
Columbia University College of Phys & Surgeons Recruiting
New York, New York, United States, 10032
Contact    212-317-3141      
Principal Investigator: Mark Stein         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact    646-888-4545      
Principal Investigator: James J Harding         
United States, Texas
The START Center for Cancer Care Recruiting
San Antonio, Texas, United States, 78229
Contact    210-593-5270      
Principal Investigator: Amita Patnaik         
Japan
National Cancer Center Hospital East Not yet recruiting
Kashiwa, Chiba, Japan, 277 8577
Contact    81120360605      
Principal Investigator: Toshihiko Doi         
National Cancer Center Hospital Not yet recruiting
Chuo-Ku, Tokyo, Japan, 104-0045
Contact    81120360605      
Principal Investigator: Yutaka Fujiwara         
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact    82220722390      
Principal Investigator: YUNG-JUE BANG         
Severance Hospital Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Contact    82222288132      
Principal Investigator: Hyun Cheol Chung         
Spain
Hospital Clinico Universitario Virgen de la Victoria Recruiting
Malaga, Andalucia, Spain, 29010
Contact    34951032250      
Principal Investigator: José M. Trigo Pérez         
Fundación Jiménez Díaz-Oncology Recruiting
Madrid, Spain, 28040
Contact    34915504800      
Principal Investigator: Victor Moreno         
Hospital Madrid Norte Sanchinarro Recruiting
Madrid, Spain, 28050
Contact    34917567861      
Principal Investigator: Emiliano Calvo Aller         
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: NCT03099109     History of Changes
Other Study ID Numbers: 16526
I9A-MC-JLDA ( Other Identifier: Eli Lilly and Company )
2016-003195-42 ( EudraCT Number )
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 1, 2018

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