A Phase 1 interventional study of LY4336619 and Sofetabart Mipitecan (Sofe-M) in Endometrial Neoplasms, Ovarian Neoplasms and Neoplasms, Germ Cell and Embryonal, sponsored by Eli Lilly and Company. Not yet recruiting at 23 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Treatment
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.
1,425 studies on the registry are indexed under Endometrial Neoplasms; 473 are open to participants now.
This study's planned enrollment of 370 is above the median of 71 across 1,026 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Escalating doses of LY4336619 administered intravenously (IV)
Drug: LY4336619
Comparing 2 or more doses (evaluated during dose escalation) of LY4336619 administered IV
Drug: LY4336619
Comparing LY4336619 in combination with Sofe-M administered IV
Drug: LY4336619 · Drug: Sofetabart Mipitecan (Sofe-M)
LY4336619 administered IV
Drug: LY4336619
Administered IV
Administered IV
Number of Participants with Dose-Limiting Toxicities (DLTs)
Time frame: From Cycle 1 Day 1 through Cycle 2 Day 1 (approximately 21 days)
Objective Response Rate (ORR) of LY4336619 in the Dose Expansion Arms
Investigator-assessed ORR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: Up to approximately 2 years
Pharmacokinetics (PK) of LY4336619: Maximum Concentration (Cmax)
Time frame: Up to approximately 2 years
PK of LY4336619: Area under the Concentration-time Curve (AUC)
Time frame: Up to approximately 2 years
PK of Sofe-M in the Combination Cohorts: Cmax
Time frame: Up to approximately 2 years
PK of Sofe-M in the Combination Cohorts: AUC
Time frame: Up to approximately 2 years
ORR of LY4336619
Investigator assessed per RECIST v1.1.
Time frame: Up to approximately 2 years
Duration of Response (DOR) of LY4336619
Per RECIST v1.1.
Time frame: Up to approximately 2 years
Time to Response (TTR) of LY4336619
Per RECIST v1.1.
Time frame: Up to approximately 2 years
Progression-Free Survival (PFS) of LY4336619
Per RECIST v1.1.
Time frame: Up to approximately 2 years
Disease Control Rate (DCR) of LY4336619
Per RECIST v1.1.
Time frame: Up to approximately 2 years
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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