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.
- 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
- Must not have experienced a toxicity that led to permanent discontinuation of
- 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.
- 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
- Evidence of interstitial lung disease or noninfectious pneumonitis.