Status:
TERMINATED
A Study of LY3415244 in Participants With Advanced Solid Tumors
Lead Sponsor:
Eli Lilly and Company
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The goal of this study is to evaluate the safety of LY3415244, a PD-L1/TIM-3 bispecific antibody, administered as monotherapy to participants with advanced solid tumors.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03752177
Start Date
November 22 2018
End Date
October 9 2019
Last Update
October 22 2021
Active Locations (6)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
3
Institut Jules Bordet
Brussels, Belgium, 1000
4
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000