A Study of LY3321367 Alone or With LY3300054 in Participants With Advanced Relapsed/Refractory Solid Tumors
NCT ID: NCT03099109
Last Updated: 2023-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
209 participants
INTERVENTIONAL
2017-04-12
2023-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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LY3321367 Dose Escalation
LY3321367 given intravenously (IV).
LY3321367
Administered IV
LY3321367 + LY3300054 Dose Escalation
LY3321367 and LY3300054 given IV.
LY3321367
Administered IV
LY3300054
Administered IV
LY3321367 Dose Expansion
LY3321367 given IV.
LY3321367
Administered IV
LY3321367 + LY3300054 Dose Expansion
LY3321367 and LY3300054 given IV.
LY3321367
Administered IV
LY3300054
Administered IV
Japanese Arm D LY3321367
LY3321367 given IV.
LY3321367
Administered IV
Japanese Arm E LY3300054
LY3300054 given IV.
LY3300054
Administered IV
Japanese Arm F LY3321367 + LY3300054
LY3321367 and LY3300054 given IV.
LY3321367
Administered IV
LY3300054
Administered IV
Interventions
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LY3321367
Administered IV
LY3300054
Administered IV
Eligibility Criteria
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Inclusion Criteria
* 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 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 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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The University of Arizona Cancer Center
Tucson, Arizona, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Columbia University College of Phys & Surgeons
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Peggy and Charles Stephenson Oklahoma Cancer Center
Oklahoma City, Oklahoma, United States
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
The START Center for Cancer Care
San Antonio, Texas, United States
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
National Cancer Center Hospital
Chuo-Ku, Tokyo, Japan
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Hospital Clinico Universitario Virgen de la Victoria
Málaga, Andalusia, Spain
Fundación Jiménez Díaz-Oncology
Madrid, , Spain
Hospital Madrid Norte Sanchinarro
Madrid, , Spain
Countries
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References
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Harding JJ, Moreno V, Bang YJ, Hong MH, Patnaik A, Trigo J, Szpurka AM, Yamamoto N, Doi T, Fu S, Calderon B, Velez de Mendizabal N, Calvo E, Yu D, Gandhi L, Liu ZT, Galvao VR, Leow CC, de Miguel MJ. Blocking TIM-3 in Treatment-refractory Advanced Solid Tumors: A Phase Ia/b Study of LY3321367 with or without an Anti-PD-L1 Antibody. Clin Cancer Res. 2021 Apr 15;27(8):2168-2178. doi: 10.1158/1078-0432.CCR-20-4405. Epub 2021 Jan 29.
Related Links
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A Study of LY3321367 Alone or With LY3300054 in Participants With Advanced Relapsed/Refractory Solid Tumors
Other Identifiers
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I9A-MC-JLDA
Identifier Type: OTHER
Identifier Source: secondary_id
2016-003195-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16526
Identifier Type: -
Identifier Source: org_study_id
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