Clinical Trials /

A Study of LY3415244 in Participants With Advanced Solid Tumors

NCT03752177

Description:

The goal of this study is to evaluate the safety of LY3415244, a PD-L1/TIM-3 bispecific antibody, administered as monotherapy to participants with advanced solid tumors.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Terminated

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of LY3415244 in Participants With Advanced Solid Tumors
  • Official Title: A Phase 1a/1b Study of LY3415244, a Bispecific Antibody in Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: 17099
  • SECONDARY ID: J1C-MC-JZDA
  • SECONDARY ID: 2018-001598-25
  • NCT ID: NCT03752177

Conditions

  • Solid Tumor

Interventions

DrugSynonymsArms
LY3415244LY3415244 Dose Escalation

Purpose

The goal of this study is to evaluate the safety of LY3415244, a PD-L1/TIM-3 bispecific antibody, administered as monotherapy to participants with advanced solid tumors.

Trial Arms

NameTypeDescriptionInterventions
LY3415244 Dose EscalationExperimentalLY3415244 administered intravenously (IV).
  • LY3415244
LY3415244 Dose ExpansionExperimentalLY3415244 administered IV.
  • LY3415244

Eligibility Criteria

        Inclusion Criteria:

          -  For Phase 1a/b, histologic or cytologic confirmation of advanced solid tumor.

          -  For Phase 1a/b, biopsy of tumor samples are required. Newly obtained core or
             excisional biopsy of a tumor lesion prior to study enrollment and undergo a biopsy
             procedure during the study.

          -  Phase 1a, prior anti-PD-1 or anti-PD-L1 therapy or other immunotherapy is allowed.

          -  Phase 1b, prior anti-PD-1 or anti-PD-L1 therapy is required where anti-PD-1 or
             anti-PD-L1 is standard of care in respective tumor types if the following criteria are
             met:

               -  Must not have experienced a toxicity that led to permanent discontinuation of
                  prior immunotherapy

               -  Must have completely recovered to baseline level prior to screening from any
                  adverse events (AEs) that occurred from receiving prior immunotherapy

               -  Must not have experienced a Grade ≥3 immune-related AE or immune related
                  neurologic or ocular AE, pneumonitis or cardiomyopathy of any grade while
                  receiving prior immunotherapy

               -  Must not have required immunosuppressive agent, other than corticosteroids for
                  the management of an adverse event and not currently require maintenance doses of
                  >10 milligrams (mg) prednisone (or equivalent) per day

          -  Must have at least 1 measurable lesion as defined by the Response Evaluation Criteria
             in Solid Tumors (RECIST 1.1).

          -  Have adequate organ function.

          -  Have an estimated life expectancy ≥12 weeks, in the judgement 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 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 known 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with LY3415244 Dose-Limiting Toxicities (DLTs)
Time Frame:Baseline through Cycle 1 (28 Day Cycle)
Safety Issue:
Description:Number of participants with LY3415244 DLTs

Secondary Outcome Measures

Measure:PK: Minimum Concentration (Cmin) of LY3415244
Time Frame:Predose Cycle 1 Day 1 (28 Day Cycle) through Follow up (Estimated up to 6 Months)
Safety Issue:
Description:PK: Cmin of LY3415244
Measure:Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
Time Frame:Baseline through Measured Progressive Disease (Estimated up to 24 Months)
Safety Issue:
Description:ORR: Percentage of participants who achieve CR or PR
Measure:Duration of Response (DoR)
Time Frame:Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 24 Months)
Safety Issue:
Description:DoR
Measure:Time to Response (TTR)
Time Frame:Baseline to Date of CR or PR (Estimated up to 24 Months)
Safety Issue:
Description:TTR
Measure:Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and Stable Disease
Time Frame:Baseline through Measured Progressive Disease (Estimated up to 24 Months)
Safety Issue:
Description:DCR: Percentage of participants with a best overall response of CR, PR, and stable disease
Measure:Progression Free Survival (PFS)
Time Frame:Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 24 Months)
Safety Issue:
Description:PFS

Details

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

Trial Keywords

  • TIM-3
  • PD-L1

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