J1C-MC-JZDA

JRCT ID: jRCT2080224186

Registered date:13/12/2018

Basic Information

• Recruitment status: completed
• Date of first enrollment: 21/11/2018
• Target sample size: 24
• Countries of recruitment: Japan,North America,Europe
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : LY3415244
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : IV Infusion on D1 (28 Day Cycle)

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

Outcome(s)

Primary Outcome

safety
DLT,safety

Secondary Outcome

exploratory
pharmacokinetics
other
PK, ORR, Biomarker analysis, other

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include 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 greater than or equal to 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 greater than or equal to 12 weeks, in the judgement of the investigator.

Exclude 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.

Related Information

• Primary Sponsor: Eli Lilly Japan K.K.
• Secondary Sponsor: National cancer center hospital, National cancer center hospital east
• Source(s) of Monetary Support: -
• Secondary ID(s): NCT03752177,JapicCTI-184248