Drugs / Sofetabart Mipitecan
Sofetabart Mipitecan
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06400472 | May 2024 → Jun 2029 expected | colorectal neoplasm, endometrium neoplasm, non-small cell lung carcinoma, ovarian neoplasm +3 | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07213804 | Oct 2025 → Nov 2028 expected | fallopian tube neoplasm, metastatic neoplasm, ovarian neoplasm, peritoneal neoplasm | Eli Lilly and Company | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-01-20 | Eli Lilly and Company | Regulatory Lilly's sofetabart mipitecan receives U.S. FDA's Breakthrough Therapy designation for the treatment of certain patients with platinum-resistant ovarian cancer lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to sofetabart mipitecan (LY4170156) for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received prior bevacizumab and mirvetuximab soravtansine, if eligible. |
| 2025-06-02 | Eli Lilly and Company | Results Lilly presents first clinical data for its investigational, next-generation FRα targeting ADC in platinum-resistant ovarian cancer at the 2025 ASCO Annual Meeting lilly.com ↗
A preliminary overall objective response rate (ORR) of 55% was observed at the potential recommended Phase 2 dose of 4 mg/kg. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-01-20 | Eli Lilly and Company | Lilly's sofetabart mipitecan receives U.S. FDA's Breakthrough Therapy designation for the treatment of certain patients with platinum-resistant ovarian cancer lilly.com ↗ |
| 2025-06-02 | Eli Lilly and Company | Lilly presents first clinical data for its investigational, next-generation FRα targeting ADC in platinum-resistant ovarian cancer at the 2025 ASCO Annual Meeting lilly.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sofetabart Mipitecan | “Sofetabart Mipitecan (LY4170156), an Antibody-Drug Conjugate Targeting Folate Receptor α-Expressing Tumor Cells” NCT06400472 ↗ |
| Known as | LY4170156 | “Sofetabart Mipitecan (LY4170156)” NCT07213804 ↗ |
| Known as | Sofe-M | “Sofetabart Mipitecan (Sofe-M)” NCT07213804 ↗ |
| Route | Intravenous | “Escalating doses of Sofe-M administered intravenously (IV)” NCT06400472 ↗ |