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

Completed · Phase 1

Conditions studied: Solid Tumor

In brief

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.

Key facts

Study ID

NCT03099109

Run by

Eli Lilly and Company

People needed

209

Starts

2017-04-12

Expected to finish

2023-08-30

Last updated by the study team

2023-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 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.

You may not qualify if…

• 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.

Where it is running

• The University of Arizona Cancer Center — Tucson, Arizona, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Columbia University College of Phys & Surgeons — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Peggy and Charles Stephenson Oklahoma Cancer Center — Oklahoma City, Oklahoma, United States
• Sarah Cannon Research Institute SCRI — Nashville, Tennessee, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• The START Center for Cancer Care — San Antonio, Texas, United States
• National Cancer Center Hospital East — Kashiwa, Chiba, Japan
• National Cancer Center Hospital — Chuo-Ku, Tokyo, Japan
• Seoul National University Hospital — Seoul, South Korea
• Severance Hospital Yonsei University Health System — Seoul, South Korea
• Hospital Clinico Universitario Virgen de la Victoria — Málaga, Andalusia, Spain
• Fundación Jiménez Díaz-Oncology — Madrid, Spain
• Hospital Madrid Norte Sanchinarro — Madrid, Spain

Full record on ClinicalTrials.gov

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