Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Cancer | Drug: LY3434172 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Study of LY3434172, a Bispecific Antibody Monotherapy in Advanced Solid Tumors |
Actual Study Start Date : | May 24, 2019 |
Actual Primary Completion Date : | March 30, 2020 |
Estimated Study Completion Date : | December 31, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: LY3434172
LY3434172 administered IV
|
Drug: LY3434172
Administered IV
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Have serious concomitant systemic disorder that would compromise the participant's ability to adhere to the protocol, including known infection with human immunodeficiency virus (HIV) unless they are well controlled on highly active antiretroviral therapy (HAART) therapy with no evidence of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections within the last 2 years, and CD4 T-cells count > 350 cells/µl , active hepatitis B virus (HBV), active hepatitis C virus (HCV), active autoimmune disorders, or prior documented severe autoimmune or inflammatory disorders requiring immunosuppressive treatment.
United States, Texas | |
University of Texas MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
Australia, New South Wales | |
St Vincent's Hospital | |
Sydney, New South Wales, Australia, 2010 | |
Belgium | |
Universitair Ziekenhuis Gent | |
Gent, Belgium, 9000 | |
France | |
Institut Claudius Regaud - IUCT Oncopole | |
Toulouse cedex 9, France, 31059 | |
Korea, Republic of | |
Asan Medical Center | |
Songpa-gu, Seoul, Korea, Republic of, 05505 |
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 |
Tracking Information | |||||
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First Submitted Date ICMJE | April 26, 2019 | ||||
First Posted Date ICMJE | May 3, 2019 | ||||
Last Update Posted Date | January 6, 2021 | ||||
Actual Study Start Date ICMJE | May 24, 2019 | ||||
Actual Primary Completion Date | March 30, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline through Cycle 2 (Up to 42 Day Cycles) ] Number of participants with DLTs
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study of LY3434172, a PD-1 and PD-L1 Bispecific Antibody, in Advanced Cancer | ||||
Official Title ICMJE | A Phase 1 Study of LY3434172, a Bispecific Antibody Monotherapy in Advanced Solid Tumors | ||||
Brief Summary | The main purpose of this study is to evaluate the safety and tolerability of the study drug LY3434172, a PD-1/PD-L1 bispecific antibody, in participants with advanced solid tumors. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Advanced Cancer | ||||
Intervention ICMJE | Drug: LY3434172
Administered IV
|
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Study Arms ICMJE | Experimental: LY3434172
LY3434172 administered IV
Intervention: Drug: LY3434172
|
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
40 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2021 | ||||
Actual Primary Completion Date | March 30, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Australia, Belgium, France, Korea, Republic of, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03936959 | ||||
Other Study ID Numbers ICMJE | 17101 J1E-MC-JZEA ( Other Identifier: Eli Lilly and Company ) 2018-003871-37 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Eli Lilly and Company | ||||
Study Sponsor ICMJE | Eli Lilly and Company | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Eli Lilly and Company | ||||
Verification Date | January 1, 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |