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A Study of LY3434172, a PD-1 and PD-L1 Bispecific Antibody, in Advanced Cancer

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03936959
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: LY3434172 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Estimated Primary Completion Date : June 14, 2020
Estimated Study Completion Date : November 30, 2020

Arm Intervention/treatment
Experimental: LY3434172
LY3434172 administered IV
Drug: LY3434172
Administered IV




Primary Outcome Measures :
  1. Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline through Cycle 2 (Up to 42 Day Cycles) ]
    Number of participants with DLTs


Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Minimum Concentration (Cmin) of LY3434172 [ Time Frame: Predose Cycle 1 Day 1 through Cycle 4 Day 1 (Up to 42 Day Cycle) ]
    PK: Cmin of LY3434172

  2. Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 12 Months) ]
    ORR: Percentage of participants with a CR or PR

  3. Duration of Response (DOR) [ Time Frame: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months) ]
    DOR

  4. Time to Response (TTR) [ Time Frame: Baseline to Date of CR or PR (Estimated up to 12 Months) ]
    TTR

  5. Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), CR or PR [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 12 Months) ]
    DCR: Percentage of participants who exhibit SD, CR or PR



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:

  • Must have histological or cytological evidence of a diagnosis of cancer that is not amenable/resistant to approved standard-of-care therapy for the following solid tumors: Melanoma, non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), urothelial cancer, gastric cancer, colorectal cancer, biliary tract cancer, anal cancer, nasopharyngeal cancer, esophageal cancer, SCLC, ovarian cancer, mesothelioma, pan-tumor MSIhi solid tumors, hepatocellular carcinoma, merkel cell cancer, cutaneous squamous cell carcinoma, endometrial cancer, breast cancer, cervical cancer, thyroid cancer, salivary cancer, and prostate cancer who have received at least one line of standard systemic therapy for their respective tumor type in the metastatic setting with progressive locally advanced or metastatic disease. Prior anti-programmed death 1 (PD-1) and anti-programmed death ligand 1 (PD-L1) allowed if they received another therapy immediately prior to this study or there has been a lapse of approximately ≥90 days from prior therapy.
  • Must be willing to undergo pretreatment and on-treatment core needle or excisional tumor biopsies.
  • Have at least one measurable lesion assessable as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
  • Have adequate organ function.
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Have an estimated life expectancy of 12 weeks, in the judgment 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 moderate or severe cardiovascular disease.
  • Have active or suspected autoimmune disease (eg. autoimmune vasculitis, autoimmune myocarditis, among others).
  • 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.

    • Use of escalating or chronic supraphysiologic doses of corticosteroids or immunosuppressive agents (such as, exceeding 10 milligrams/day of prednisone or equivalent). Use of topical, ophthalmic, inhaled, and intranasal corticosteroids permitted.
  • Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection, Crohn's disease, ulcerative colitis, or chronic diarrhea.
  • Evidence of interstitial lung disease or noninfectious pneumonitis (active or treated by corticosteroid therapy).

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): NCT03936959


Contacts
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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
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact    205-934-5077      
Principal Investigator: Francisco Robert         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact    617-726-2515      
Principal Investigator: Xin Gao         
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact    713-563-1784      
Principal Investigator: Timothy Yap         
Australia, New South Wales
St Vincent's Hospital Recruiting
Sydney, New South Wales, Australia, 2010
Contact    61293555652      
Principal Investigator: Anthony Joshua         
Belgium
Universitair Ziekenhuis Gent Recruiting
Gent, Belgium, 9000
Contact    3293320000      
Principal Investigator: Sylvie Rottey         
France
Institut Claudius Regaud - IUCT Oncopole Recruiting
Toulouse cedex 9, France, 31059
Contact    +33 5 31 15 51 01      
Principal Investigator: Carlos Alberto GOMEZ-ROCA         
Korea, Republic of
Asan Medical Center Recruiting
Songpa-gu, Seoul, Korea, Republic of, 05505
Contact    8222243214      
Principal Investigator: Tae Won Kim         
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: NCT03936959     History of Changes
Other Study ID Numbers: 17101
J1E-MC-JZEA ( Other Identifier: Eli Lilly and Company )
2018-003871-37 ( EudraCT Number )
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 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:
PD-1
PD-L1
Additional relevant MeSH terms:
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Neoplasms
Antibodies
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs