Clinical Trials /

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

NCT03936959

Description:

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.

Related Conditions:
  • Anal Carcinoma
  • Biliary Tract Carcinoma
  • Breast Carcinoma
  • Cervical Carcinoma
  • Colorectal Carcinoma
  • Endometrial Carcinoma
  • Esophageal Carcinoma
  • Gastric Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Hepatocellular Carcinoma
  • Malignant Solid Tumor
  • Melanoma
  • Merkel Cell Carcinoma
  • Mesothelioma
  • Nasopharyngeal Carcinoma
  • Non-Small Cell Lung Carcinoma
  • Ovarian Carcinoma
  • Prostate Carcinoma
  • Salivary Gland Carcinoma
  • Skin Squamous Cell Carcinoma
  • Small Cell Lung Carcinoma
  • Thyroid Gland Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of LY3434172, a PD-1 and PD-L1 Bispecific Antibody, in Advanced Cancer
  • Official Title: A Phase 1 Study of LY3434172, a Bispecific Antibody Monotherapy in Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: 17101
  • SECONDARY ID: J1E-MC-JZEA
  • SECONDARY ID: 2018-003871-37
  • NCT ID: NCT03936959

Conditions

  • Advanced Cancer

Interventions

DrugSynonymsArms
LY3434172LY3434172

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
LY3434172ExperimentalLY3434172 administered IV
  • LY3434172

Eligibility 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).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with Dose Limiting Toxicities (DLTs)
Time Frame:Baseline through Cycle 2 (Up to 42 Day Cycles)
Safety Issue:
Description:Number of participants with DLTs

Secondary Outcome Measures

Measure:Pharmacokinetics (PK): Minimum Concentration (Cmin) of LY3434172
Time Frame:Predose Cycle 1 Day 1 through Cycle 4 Day 1 (Up to 42 Day Cycle)
Safety Issue:
Description:PK: Cmin of LY3434172
Measure: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)
Safety Issue:
Description:ORR: Percentage of participants with a CR or PR
Measure: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)
Safety Issue:
Description:DOR
Measure:Time to Response (TTR)
Time Frame:Baseline to Date of CR or PR (Estimated up to 12 Months)
Safety Issue:
Description:TTR
Measure: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)
Safety Issue:
Description:DCR: Percentage of participants who exhibit SD, CR or PR

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Eli Lilly and Company

Trial Keywords

  • PD-1
  • PD-L1

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