A Study of LY4336619 in Adult Participants With Advanced Solid Tumors
Key facts
- Where
- Boston, Chicago, Columbus, Duarte, Houston, La Jolla, Lake Success, New York, Scottsdale, and West Valley City, United StatesSee the 11 sites
- Phase
- Phase 1
Where in United States
- Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer CenterBoston, United StatesNo longer taking part
- The University of Chicago Medical Center (UCMC)Chicago, United StatesNo longer taking part
- The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Rese -TColumbus, United StatesNo longer taking part
- City of HopeDuarte, United StatesNo longer taking part
- MD Anderson Cancer CenterHouston, United StatesNo longer taking part
- University of California, San Diego (UCSD) - Moores Cancer CenterLa Jolla, United StatesNo longer taking part
- South Texas Accelerated Research Therapeutics (START) - New York - Long IslandLake Success, United StatesNo longer taking part
- David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew York, United StatesNo longer taking part
- New York University (NYU) Clinical Cancer CenterNew York, United StatesNo longer taking part
- HonorHealthScottsdale, United StatesNo longer taking part
- START Mountain RegionWest Valley City, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07928258EU 2026-526553-33-00
- Record updated
- 10 November 2026
- Original description
The main purpose of this study is to evaluate how safe and effective LY4336619 is in adults with advanced cancer. Some participants will receive LY4336619 alone, and some will receive it with another cancer medicine. Participants will be in the study for up to 2 years, depending on how they tolerate and respond to treatment.Read full original descriptionShow less
A First-in Human, Phase 1 Trial to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LY4336619, an Alkaline Phosphatase Placental-Like 2 (ALPPL2) T- Cell Engager Bispecific Antibody, in Adult Participants With Advanced Solid Tumors
The main purpose of this study is to evaluate how safe and effective LY4336619 is in adults with advanced cancer. Some participants will receive LY4336619 alone, and some will receive it with another cancer medicine. Participants will be in the study for up to 2 years, depending on how they tolerate and respond to treatment.
Inclusion: Have histological diagnosis of locally advanced or metastatic solid tumor malignancy; Have a life expectancy of at least 12 weeks as judged by the investigator; Must be an appropriate candidate for study treatment. Study treatment is considered appropriate where approved measures are no longer effective or are not considered appropriate or safe in the opinion of the investigator, or the individual refuses the remaining most appropriate standard of care treatment; Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale or Karnofsky performance status of at least 80%.
Exclusion: Residual symptoms of neurotoxicity from prior chimeric antigen receptor-modified T cell (CAR-T) or bispecifics; Has any unresolved toxicities from prior therapy greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0 Grade 1 at the time of starting study treatment except for alopecia, endocrine adverse events (AEs) on replacement therapy, and Grade 2 neuropathy; Has a known or suspected history of active central nervous system (CNS) involvement; Has a history of carcinomatous meningitis; Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease; Has significant cardiovascular disease; Has an active uncontrolled systemic bacterial, viral, fungal, or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which, in the opinion of the investigator and the sponsor, makes it undesirable for the individual to participate in the trial. Screening for chronic conditions is not required.