Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY4336619 · 1 trial · 6 indications
Investigator-assessed ORR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
| Arm | Type | Description |
|---|---|---|
| LY4336619 Dose Escalation | EXPERIMENTAL | Escalating doses of LY4336619 administered intravenously (IV) |
| LY4336619 Dose Optimization | EXPERIMENTAL | Comparing 2 or more doses (evaluated during dose escalation) of LY4336619 administered IV |
| LY4336619 and Sofetabart Mipitecan (Sofe-M) Combination | EXPERIMENTAL | Comparing LY4336619 in combination with Sofe-M administered IV |
| LY4336619 Dose Expansion | EXPERIMENTAL | LY4336619 administered IV |
| Name | Type | Description |
|---|---|---|
| LY4336619 | DRUG | Administered IV |
| Sofetabart Mipitecan (Sofe-M) | DRUG | Administered IV |
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 m...
LY4336619 is an investigational small molecule being developed by Eli Lilly and Company for endometrial neoplasms and other advanced solid tumors. It is in Phase 1 clinical development and has not been approved for any use. It is being studied in adults with advanced solid tumors, including endometrial, ovarian, germ cell, non-small-cell lung, and stomach cancers.
LY4336619 is being studied as a treatment for endometrial neoplasms and other advanced solid tumors in adults. It is investigational and has not been approved for endometrial cancer or any other indication. Its only registered trial enrolls participants with endometrial neoplasms alongside ovarian, germ cell, non-small-cell lung, and stomach cancers.
Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY, is developing LY4336619. Lilly is the sponsor of the Phase 1 study of the compound in advanced solid tumors. The drug is an investigational small molecule and is not yet available commercially.
LY4336619 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulator. The single registered trial is a Phase 1 study in adult participants with advanced solid tumors that has not yet begun recruiting.
LY4336619 is being studied in one trial, NCT07928258, titled A Study of LY4336619 in Adult Participants With Advanced Solid Tumors. The Phase 1 trial is not yet recruiting and plans to enroll 370 participants aged 18 and older across the United States, France, Japan, Spain, and the United Kingdom.
The NCT07928258 trial enrolls adults with endometrial neoplasms, ovarian neoplasms, germ cell and embryonal neoplasms, non-small-cell lung carcinoma, and stomach neoplasms. It is a controlled Phase 1 study with an estimated enrollment of 370 participants. Participants must be at least 18 years old, and the study accepts all sexes.