A Study of LY3415244 in Participants With Advanced Solid Tumors
Condition: Solid Tumor
MeSH terms: Neoplasms
Intervention: LY3415244
Intervention description: Administered IV
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: TIM-3; PD-L1

Summary:

      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.
    

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.