Drugs / SIM0505
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06792552 | Feb 2025 → Feb 2028 expected | cancer | NextCure, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-06-01 | NextCure, Inc. | Results NextCure Presents Positive SIM0505 Phase 1 Dose Escalation Data in Patients with Gynecologic Cancers at ASCO 2026 nextcure.com ↗
today announced the presentation of positive Phase 1 dose escalation data for SIM0505 at the American Society for Clinical Oncology (ASCO 2026) in Chicago, IL (poster #246). |
| 2026-05-29 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Results Simcere Zaiming Presents 9 Studies at the 2026 ASCO Annual Meeting simcere.com ↗
The poster presented at this year’s ASCO meeting provides preliminary evidence of the therapeutic potential of SIM0505 in patients with advanced solid tumors. |
| 2026-04-08 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory FDA Granted Fast Track Designation for SIM0505 (CDH6 ADC) for the Treatment of Ovarian Cancer simcere.com ↗
April 8 2026, Simcere Zaiming announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for SIM0505, for the treatment of platinum-resistant ovarian cancer. |
| 2026-04-07 | NextCure, Inc. | Regulatory NextCure Receives Fast Track Designation for SIM0505 (CDH6 ADC) in Ovarian Cancer nextcure.com ↗
NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, today announced that the U.S. Food And Drug Administration (FDA) has granted Fast Track Designation for SIM0505 for the treatment of platinum-resistant ovarian cancer. |
| 2025-01-06 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory SIM0505, an ADC candidates Simcere Zaiming developed using proprietary technology platform, is entering trials both in China and the USA simcere.com ↗
SIM0505, a CDH6 Antibody-Drug Conjugate independently developed by the company has received a Clinical Trial Approval in advanced solid tumors issued by the China National Medical Products Administration (NMPA) of China. |
All press releases naming this drug 10 releases
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SIM0505 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06792552 ↗ |