Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
study ends around

Description

Summary

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.

Official Title

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

Keywords

Endometrial Neoplasms, Ovarian Neoplasms, Neoplasms, Germ Cell and Embryonal, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms, Neoplasms, Germ Cell and Embryonal Neoplasms, Non-Small-Cell Lung Carcinoma, Sofetabart Mipitecan (Sofe-M)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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%.

You CAN'T join if...

  • 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.
  • Residual symptoms of neurotoxicity from prior chimeric antigen receptor-modified T cell (CAR-T) or bispecifics.
  • 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.
  • 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.

Locations

  • University of California, San Diego (UCSD) - Moores Cancer Center
    La Jolla California 92037 United States
  • City of Hope
    Duarte California 91010 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
ID
NCT07928258
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 370 study participants
Last Updated