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



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:April 12, 2017
End Date:June 14, 2020
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Email:ClinicalTrials.gov@lilly.com
Phone:1-317-615-4559

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A Phase 1a/1b Study of LY3321367, an Anti-TIM-3 Antibody, Administered Alone or in Combination With LY3300054, an Anti-PD-L1 Antibody, in 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.


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.
We found this trial at
9
sites
Tucson, Arizona 85724
Principal Investigator: Daruka Mahadevan
Phone: 520-626-4332
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Geoffrey I Shapiro
Phone: 617-632-4292
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Siqing Fu
Phone: 713-745-6754
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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Kashiwa, Chiba 27785
Principal Investigator: Toshihiko Doi
Phone: 81120360605
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Kashiwa,
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Nashville, Tennessee 37203
Principal Investigator: SMO Sarah Cannon Research Inst.
Phone: 615-329-7274
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: James J Harding
Phone: 646-888-4545
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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New York, New York 10032
Principal Investigator: Mark Stein
Phone: 212-317-3141
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Oklahoma City, Oklahoma 73104
Principal Investigator: Susanna Ulahannan
Phone: 405-271-8777
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Oklahoma City, OK
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San Antonio, Texas 78229
Principal Investigator: Amita Patnaik
Phone: 210-593-5270
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San Antonio, TX
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