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Also known as SIM0505 for injection
SIM0505 · 1 trial · 8 indications
| Arm | Type | Description |
|---|---|---|
| SIM0505 mono dose escalation | EXPERIMENTAL | Every 21 days is one cycle. Multiple dose levels of SIM0505 will be explored in dose escalation, and determine the maximum tolerated dose. |
| SIM0505 mono dose optimization - PROC | EXPERIMENTAL | Every 21 days is one cycle. 2-3 dose levels of SIM0505 will be explored in dose optimization, and determine the recommended dose (RD) of SIM0505 and evaluate the preliminary anti-tumor activity of SIM0505 in PROC. |
| SIM0505 mono dose optimization - RCC | EXPERIMENTAL | Every 21 days is one cycle. 2 dose levels of SIM0505 will be explored in dose optimization, and determine the recommended dose (RD) of SIM0505 and evaluate the preliminary anti-tumor activity of SIM0505 in RCC. |
| SIM0505 mono dose optimization - USC | EXPERIMENTAL | Every 21 days is one cycle. 2 dose levels of SIM0505 will be explored in dose optimization, and determine the recommended dose (RD) of SIM0505 and evaluate the preliminary anti-tumor activity of SIM0505 in USC. |
| SIM0505 mono dose optimization - NSCLC | EXPERIMENTAL | Every 21 days is one cycle. 2 dose levels of SIM0505 will be explored in dose optimization, and determine the recommended dose (RD) of SIM0505 and evaluate the preliminary anti-tumor activity of SIM0505 in NSCLC. |
| Name | Type | Description |
|---|---|---|
| SIM0505 for injection | DRUG | Every 21 days is one cycle. Multiple dose levels of SIM0505 will be explored in dose escalation, and determine the maximum tolerated dose. |
Inclusion Criteria: 1. Written informed consent is obtained prior to any procedures that are not considered standard of care. 2. ≥18 years of age. 3. In Part 1: 1. Participants with histologically or cytologically confirmed advanced solid tumors, who have failed or are ineligible for standard o...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
SIM0505 is an investigational small molecule developed by NextCure, Inc. (NXTC) for advanced solid tumors. It is being studied in a Phase 1 clinical trial in adults with several cancer types, including platinum resistant ovarian cancer, fallopian tube cancer, renal cell carcinoma, uterine serous carcinoma, NSCLC, and primary peritoneal cancer.
SIM0505 is being evaluated for the treatment of advanced solid tumors. The Phase 1 study enrolls adults with platinum resistant ovarian cancer, fallopian tube cancer, renal cell carcinoma including papillary renal cell carcinoma, uterine serous carcinoma, non-small cell lung cancer, and primary peritoneal cancer.
SIM0505 targets CDH6, a protein also known as cadherin-6. CDH6 is a cell surface adhesion protein that is expressed in certain tumor types, and SIM0505 is designed as a small molecule directed against this target. It is being studied in patients with advanced solid tumors.
SIM0505 is being developed by NextCure, Inc., which trades on the Nasdaq under the ticker NXTC. The company is running the Phase 1 clinical program for the drug in advanced solid tumors, with study sites in the United States and China.
SIM0505 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The ongoing Phase 1 trial is currently recruiting participants and is designed to enroll 738 patients with advanced solid tumors.
SIM0505 is being studied in one active clinical trial, NCT06792552, titled A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors. The trial is recruiting, is controlled, enrolls 738 participants aged 18 years and older, and includes sites in the United States and China.
Yes, SIM0505 for injection is another name for SIM0505. Both refer to the same investigational small molecule developed by NextCure, Inc. (NXTC) that targets CDH6 and is being evaluated in a Phase 1 trial in patients with advanced solid tumors.