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Not yet taking people in United KingdomPhase 1

LY4336619 for adults with advanced solid tumors, alone or with another medicine

Tests LY4336619, alone or combined, in adults with advanced solid cancers.

Key facts

Who runs it
Eli Lilly and Company
Where
Manchester and Sutton, United KingdomSee the 2 sitesAlso in 4 other countries, 21 sites
Registry title
A Study of LY4336619 in Adult Participants With Advanced Solid Tumors
Status
Not yet recruiting
Phase
Phase 1
People taking part
370 people, planned
Starts
Dec 2026
Expected to end
Mar 2032
Type of study
Interventional, 4 groups
Treatments tested
  • LY4336619
  • Sofetabart Mipitecan (Sofe-M)
Record updated
10 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with locally advanced or metastatic solid tumors, for whom approved treatments no longer work or are not appropriate.

Age
18 years and older.
Sex
All sexes can join.
Disease stage
Locally advanced or metastatic solid tumor, confirmed by tissue examination.
Earlier treatment
Approved treatments no longer work or are not appropriate or safe, or the person refuses the remaining standard care. Leftover side effects from earlier treatment must be Grade 1 or milder, except hair loss, hormone problems treated with replacement, and Grade 2 nerve damage.

Main reasons for not taking part

  • Known or suspected active involvement of the central nervous system, or carcinomatous meningitis
  • Current or past central nervous system disease such as stroke, epilepsy, or neurodegenerative disease
  • Lasting nerve-toxicity symptoms from earlier CAR-T cell therapy or bispecific antibody treatment
  • Significant heart or blood vessel disease
  • Active uncontrolled infection or another significant active illness

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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%

Who cannot take part

  • 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

Where in United Kingdom

Also in 4 other countries, 21 sites

  • The Christie NHS Foundation TrustManchester, United KingdomNo longer taking part
  • Royal Marsden Hospital - SurreySutton, United KingdomNo longer taking part

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • LY4336619 Dose EscalationTreatment being tested

    Escalating doses of LY4336619 administered intravenously (IV)

    Treatment: LY4336619

  • LY4336619 Dose OptimizationTreatment being tested

    Comparing 2 or more doses (evaluated during dose escalation) of LY4336619 administered IV

    Treatment: LY4336619

  • LY4336619 and Sofetabart Mipitecan (Sofe-M) CombinationTreatment being tested

    Comparing LY4336619 in combination with Sofe-M administered IV

    Treatment: LY4336619 and Sofetabart Mipitecan (Sofe-M)

  • LY4336619 Dose ExpansionTreatment being tested

    LY4336619 administered IV

    Treatment: LY4336619

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Plain-language title
LY4336619 for adults with advanced solid tumors, alone or with another medicineGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 11 November 2026.
Record updated
10 November 2026