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.
| Field | Value | Source |
|---|---|---|
| Title | A Study of LY4336619 in Adult Participants With Advanced Solid Tumors | ClinicalTrials.gov |
| NCT number | NCT07928258 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 370 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Eli Lilly and Company | ClinicalTrials.gov |
| Conditions | Endometrial Neoplasms, Ovarian Neoplasms, Neoplasms, Germ Cell and Embryonal, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms, Neoplasms | ClinicalTrials.gov |
| Interventions | LY4336619, Sofetabart Mipitecan (Sofe-M) | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Number of Participants with Dose-Limiting Toxicities (DLTs) | From Cycle 1 Day 1 through Cycle 2 Day 1 (approximately 21 days) | ClinicalTrials.gov | |
| Primary | Objective Response Rate (ORR) of LY4336619 in the Dose Expansion Arms | Up to approximately 2 years | Investigator-assessed ORR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | ClinicalTrials.gov |
| Secondary | Pharmacokinetics (PK) of LY4336619: Maximum Concentration (Cmax) | Up to approximately 2 years | ClinicalTrials.gov | |
| Secondary | PK of LY4336619: Area under the Concentration-time Curve (AUC) | Up to approximately 2 years | ClinicalTrials.gov | |
| Secondary | PK of Sofe-M in the Combination Cohorts: Cmax | Up to approximately 2 years | ClinicalTrials.gov | |
| Secondary | PK of Sofe-M in the Combination Cohorts: AUC | Up to approximately 2 years | ClinicalTrials.gov | |
| Secondary | ORR of LY4336619 | Up to approximately 2 years | Investigator assessed per RECIST v1.1. | ClinicalTrials.gov |
| Secondary | Duration of Response (DOR) of LY4336619 | Up to approximately 2 years | Per RECIST v1.1. | ClinicalTrials.gov |
| Secondary | Time to Response (TTR) of LY4336619 | Up to approximately 2 years | Per RECIST v1.1. | ClinicalTrials.gov |
| Secondary | Progression-Free Survival (PFS) of LY4336619 | Up to approximately 2 years | Per RECIST v1.1. | ClinicalTrials.gov |
| Secondary | Disease Control Rate (DCR) of LY4336619 | Up to approximately 2 years | Per RECIST v1.1. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
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)