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A Study of LY4336619 in Adult Participants With Advanced Solid Tumors

NCT07928258, Phase 1, Not yet recruiting, Eli Lilly and Company

Trial 10

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

FieldValueSource
TitleA Study of LY4336619 in Adult Participants With Advanced Solid TumorsClinicalTrials.gov
NCT numberNCT07928258ClinicalTrials.gov
StatusNot yet recruitingClinicalTrials.gov
PhasesPhase 1ClinicalTrials.gov
Enrollment370 participants, estimatedClinicalTrials.gov
Lead sponsorEli Lilly and CompanyClinicalTrials.gov
ConditionsEndometrial Neoplasms, Ovarian Neoplasms, Neoplasms, Germ Cell and Embryonal, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms, NeoplasmsClinicalTrials.gov
InterventionsLY4336619, Sofetabart Mipitecan (Sofe-M)ClinicalTrials.gov
First posted2026-11-10ClinicalTrials.gov
Last updated2026-11-10ClinicalTrials.gov

Registered outcomes 11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescriptionSource
PrimaryNumber of Participants with Dose-Limiting Toxicities (DLTs)From Cycle 1 Day 1 through Cycle 2 Day 1 (approximately 21 days)ClinicalTrials.gov
PrimaryObjective Response Rate (ORR) of LY4336619 in the Dose Expansion ArmsUp to approximately 2 yearsInvestigator-assessed ORR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.ClinicalTrials.gov
SecondaryPharmacokinetics (PK) of LY4336619: Maximum Concentration (Cmax)Up to approximately 2 yearsClinicalTrials.gov
SecondaryPK of LY4336619: Area under the Concentration-time Curve (AUC)Up to approximately 2 yearsClinicalTrials.gov
SecondaryPK of Sofe-M in the Combination Cohorts: CmaxUp to approximately 2 yearsClinicalTrials.gov
SecondaryPK of Sofe-M in the Combination Cohorts: AUCUp to approximately 2 yearsClinicalTrials.gov
SecondaryORR of LY4336619Up to approximately 2 yearsInvestigator assessed per RECIST v1.1.ClinicalTrials.gov
SecondaryDuration of Response (DOR) of LY4336619Up to approximately 2 yearsPer RECIST v1.1.ClinicalTrials.gov
SecondaryTime to Response (TTR) of LY4336619Up to approximately 2 yearsPer RECIST v1.1.ClinicalTrials.gov
SecondaryProgression-Free Survival (PFS) of LY4336619Up to approximately 2 yearsPer RECIST v1.1.ClinicalTrials.gov
SecondaryDisease Control Rate (DCR) of LY4336619Up to approximately 2 yearsPer RECIST v1.1.ClinicalTrials.gov

Outcomes 0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured asSource

Results by group 0

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnitsSource

Participant flow 0

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits countedSource

Adverse events 0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEventsSource

Adverse event totals 0

The totals the trial posted for each group.

TotalGroupAffectedAt riskSource

Papers 0

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource

Grants 0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal yearsSource

Trial comparisons 0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource

Tests 0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed asSource

Source 5

FieldValueSource
Releasetrials-2026-11-12-0.4.0ClinicalTrials.gov
Release manifest SHA-2560f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4ClinicalTrials.gov
Registry capture2026-11-12ClinicalTrials.gov
Results copy, AACT2026-03-23ClinicalTrials.gov
NIH clinical studies file2026-11-13ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)