A Study of LY3321367 Alone or With LY3300054 in Participants With Advanced Relapsed/Refractory Solid Tumors


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.

Study Start Date

April, 12 2017

Estimated Completion Date

June 2020


  • Drug: LY3321367
  • Drug: LY3300054

Study ID

Eli Lilly and Company -- 16526



Trial ID


Study Type


Trial Phase

Phase 1

Enrollment Quota



Eli Lilly and Company

Inclusion Criteria

  • 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 prior immunotherapy.
  • 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 tissue sample.
  • 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 (ECOG) scale.
  • Must have adequate organ function.
  • Have an estimated life expectancy of 12 weeks, in judgement of the investigator.

Exclusion Criteria

  • 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 eligible).
  • 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 intestinal resection.
  • Evidence of interstitial lung disease or noninfectious pneumonitis.




18 Years and older

Accepts Healthy Volunteers


Study Locations and Contact Information (7)

Study Location Distance Name Phone Email
Dana Farber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
Columbia University College of Phys Surgeons - New York, New York 181.2 miles None None None
Columbia University College of Phys Surgeons - New York, New York 181.2 miles None None None
Columbia University College of Phys Surgeons - New York, New York 181.2 miles None None None
Columbia University College of Phys Surgeons - New York, New York 181.2 miles None None None
Memorial Sloan Kettering Cancer Center - New York, New York 187.1 miles None None None
The START Center for Cancer Care - San Antonio, Texas 1,768.2 miles None None None

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