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Not yet recruitingNCT07928258ClinicalTrials.gov record

A Study of LY4336619 in Adult Participants With Advanced Solid Tumors

Endometrial Neoplasms · Ovarian Neoplasms · Neoplasms, Germ Cell and Embryonal · Carcinoma, Non-Small-Cell Lung · Stomach Neoplasms · Neoplasms

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Phase 1
Age range
18 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
370 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Not randomized
Masking
No masking
LY4336619 Dose Escalation

Escalating doses of LY4336619 administered intravenously (IV)

Drug: LY4336619

LY4336619 Dose Optimization

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

Drug: LY4336619

LY4336619 and Sofetabart Mipitecan (Sofe-M) Combination

Comparing LY4336619 in combination with Sofe-M administered IV

Drug: LY4336619 · Drug: Sofetabart Mipitecan (Sofe-M)

LY4336619 Dose Expansion

LY4336619 administered IV

Drug: LY4336619

LY4336619 DRUG

Administered IV

Sofetabart Mipitecan (Sofe-M) DRUG

Administered IV

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Number of Participants with Dose-Limiting Toxicities (DLTs)

Time frame: From Cycle 1 Day 1 through Cycle 2 Day 1 (approximately 21 days)

Not reported in this registry record.

Objective Response Rate (ORR) of LY4336619 in the Dose Expansion Arms

Time frame: Up to approximately 2 years

Investigator-assessed ORR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Secondary measures

Pharmacokinetics (PK) of LY4336619: Maximum Concentration (Cmax)

Time frame: Up to approximately 2 years

Not reported in this registry record.

PK of LY4336619: Area under the Concentration-time Curve (AUC)

Time frame: Up to approximately 2 years

Not reported in this registry record.

PK of Sofe-M in the Combination Cohorts: Cmax

Time frame: Up to approximately 2 years

Not reported in this registry record.

PK of Sofe-M in the Combination Cohorts: AUC

Time frame: Up to approximately 2 years

Not reported in this registry record.

ORR of LY4336619

Time frame: Up to approximately 2 years

Investigator assessed per RECIST v1.1.

Duration of Response (DOR) of LY4336619

Time frame: Up to approximately 2 years

Per RECIST v1.1.

Time to Response (TTR) of LY4336619

Time frame: Up to approximately 2 years

Per RECIST v1.1.

Progression-Free Survival (PFS) of LY4336619

Time frame: Up to approximately 2 years

Per RECIST v1.1.

Disease Control Rate (DCR) of LY4336619

Time frame: Up to approximately 2 years

Per RECIST v1.1.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (23)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

23 locations

HonorHealthScottsdale, Arizona, United StatesStatus unknown
City of HopeDuarte, California, United StatesStatus unknown
University of California, San Diego (UCSD) - Moores Cancer CenterLa Jolla, California, United StatesStatus unknown
The University of Chicago Medical Center (UCMC)Chicago, Illinois, United StatesStatus unknown
Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer CenterBoston, Massachusetts, United StatesStatus unknown
South Texas Accelerated Research Therapeutics (START) - New York - Long IslandLake Success, New York, United StatesStatus unknown
New York University (NYU) Clinical Cancer CenterNew York, New York, United StatesStatus unknown
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew York, New York, United StatesStatus unknown
The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Rese -TColumbus, Ohio, United StatesStatus unknown
MD Anderson Cancer CenterHouston, Texas, United StatesStatus unknown
START Mountain RegionWest Valley City, Utah, United StatesStatus unknown
Centre Leon BerardLyon, FranceStatus unknown
Institut de Cancerologie de l'Ouest - site St-HerblainSaint-Herblain, FranceStatus unknown
Oncopole Claudius RegaudToulouse, FranceStatus unknown
Institut Gustave RoussyVillejuif, FranceStatus unknown
Shizuoka Cancer CenterShizuoka, JapanStatus unknown
National Cancer Center HospitalTokyo, JapanStatus unknown
Cancer Institute Hospital of JFCRTokyo, JapanStatus unknown
Hospital Universitario Vall d'HebronBarcelona, SpainStatus unknown
Clinica Universidad de Navarra - MadridMadrid, SpainStatus unknown
Hospital Universitario 12 de OctubreMadrid, SpainStatus unknown
The Christie NHS Foundation TrustManchester, United KingdomStatus unknown
Royal Marsden Hospital - SurreySutton, United KingdomStatus unknown

Study team and timeline

Lead sponsor
Eli Lilly and Company
Study start
2026-12 Estimated
Primary completion
2032-03 Estimated
Study completion
2032-03 Estimated
First posted
Nov 10, 2026 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) orCONTACTLillyTrials@Lilly.com1-317-615-4559
Physicians interested in becoming principal investigators please contactCONTACTclinical_inquiry_hub@lilly.com
Official study 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

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026