Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06792552 | A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors | PHASE1 | RECRUITING | 414 | — | — | Feb 26, 2025 | Aug 1, 2028 | Jan 29, 2026 | 17 | United States, China |
| 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 - Ovarian | 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 ovarian cancer. |
| SIM0505 mono dose optimization - Renal | 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 renal cancer. |
| 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 uterine cancer. |
| 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 lung cancer. |
| 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 of...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |