A Study of LY3415244 in Participants With Advanced Solid Tumors



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:November 22, 2018
End Date:October 31, 2020
Contact:There may be multiple sites in this clinial 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 LY3415244, a Bispecific Antibody in Patients With Advanced Solid Tumors

The goal of this study is to evaluate the safety of LY3415244 administered as monotherapy to
participants with advanced solid tumors.


Inclusion Criteria:

- 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
met:

- Must not have experienced a toxicity that led to permanent discontinuation of
prior immunotherapy

- 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.

Exclusion Criteria:

- 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
intestinal resection.

- Evidence of interstitial lung disease or noninfectious pneumonitis.
We found this trial at
3
sites
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Matthew David Hellmann
Phone: 6468884863
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Frank Stephen Hodi
Phone: 6176325055
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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121 Boulevard de Waterloo
Brussel, 1000
Principal Investigator: Philippe Aftimos
Phone: 3225413189
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