Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eli Lilly and Company
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
