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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 | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
SIM0505 is an investigational small molecule being developed for the treatment of advanced solid tumors, including platinum-resistant ovarian cancer, fallopian tube cancer, renal cell carcinoma, papillary renal cell carcinoma, uterine serous carcinoma, non-small cell lung cancer, and primary peritoneal cancer. It is currently in Phase 1 clinical development.
SIM0505 targets CDH6, a protein involved in cell adhesion. By targeting CDH6, the drug is designed to interfere with tumor cell survival and growth in certain solid tumors. This mechanism is being evaluated in an ongoing Phase 1 clinical trial.
SIM0505 is being developed by NextCure, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol NXTC. The company is conducting a Phase 1 clinical trial of SIM0505 in participants with advanced solid tumors.
SIM0505 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has received Fast Track designation from the FDA, which is intended to expedite the development and review of therapies for serious conditions.
SIM0505 is being studied in a Phase 1 clinical trial with the identifier NCT06792552, titled "A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors." The trial is currently recruiting participants in the United States and China, with an estimated enrollment of 738 patients.
Yes, SIM0505 is also known as SIM0505 for injection. Both names refer to the same investigational drug being developed by NextCure, Inc. for the treatment of advanced solid tumors. The drug is administered via injection and is currently in Phase 1 clinical trials.