The purpose of this study is to evaluate the safety of the study drug known as LY3321367, an
anti-T-cell immunoglobulin and mucin-domain domain-containing molecule-3 (TIM-3) antibody
administered alone or in combination with LY3300054, an anti-programmed death ligand 1
(PD-L1) antibody, in participants with advanced relapsed/refractory solid tumors.
- For Ph1a monotherapy and combination cohorts, histologic or cytologic confirmation of
advanced solid tumor.
- For Phase 1a and 1b, prior PD-1 or PD-L1 therapy or other immunotherapy is allowed, if
the following criteria are met:
- Must not have experienced a toxicity that led to permanent discontinuation of
- Must have completely recovered or recovered to baseline prior to screening from
any prior AEs occurring while receiving prior immunotherapy.
- Must not have experienced a Grade ≥3 immune-related AE or an immune-related
neurologic or ocular AE, pneumonitis or cardiomyopathy of any grade while
receiving prior immunotherapy.
- Must not have required immunosuppressive agents, other than corticosteroids for
the management of an adverse event and not currently requite maintenance doses of
>10 milligrams (mg) prednisone (or equivalent) per day.
- Must have at least 1 measurable lesion assessable using standard techniques by
Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
- Must have provided tumor tissue sample, as follows:
- For participants entering Ph1a: have submitted, if available, an archival tumor
- For participants entering Ph1b: have submitted, a sample from a newly obtained
core or excisional biopsy of a tumor lesion or a recent biopsy defined by 6
months of study enrollment (Ph1b).
- Must have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group
- Must have adequate organ function.
- Have an estimated life expectancy of 12 weeks, in judgement of the investigator.
- Have symptomatic or uncontrolled brain metastases, spinal cord compression, or
leptomeningeal disease requiring concurrent treatment, including but not limited to
surgery, radiation, and/or corticosteroids (participants receiving anticonvulsants are
- 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 active or chronic 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.