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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05642780 | SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors | PHASE2 | ACTIVE NOT_RECRUITING | 240 | — | — | Jan 17, 2023 | Dec 31, 2027 | Oct 14, 2025 | 48 | United States, Australia +4 |
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
ORR is defined as the proportion of subjects with confirmed CR or PR as the best overall response assessed per RECIST 1.1.
The percentage of subjects in the analysis population who have a negative change (decrease) in PSA level of ≥ 50% measured twice ≥ 3 weeks apart
| Arm | Type | Description |
|---|---|---|
| cohort A | EXPERIMENTAL | subjects will receive SKB264 in combination with pembrolizumab by intravenous administration |
| cohort B | EXPERIMENTAL | subjects will receive SKB264 in combination with pembrolizumab by intravenous administration |
| cohort C | EXPERIMENTAL | subjects will receive SKB264 in combination with pembrolizumab by intravenous administration |
| cohort D | EXPERIMENTAL | subjects will receive SKB264 in combination with pembrolizumab by intravenous administration |
| Cohort E | EXPERIMENTAL | subjects will receive SKB264 in combination with pembrolizumab by intravenous administration |
| Name | Type | Description |
|---|---|---|
| SKB264 | DRUG | be administrated as an intravenous (IV) infusion on Day 1,15, 29 of each 42-day cycle; |
| Pembrolizumab | DRUG | be administrated as an intravenous (IV) infusion on Day 1 of each 42-day cycle; |
Inclusion Criteria: 1. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 . 2. Subjects with expected survival ≥ 3 months. 3. Cohort A: Subjects with recurrent or metastatic cervical cancer 4. Cohort B: Subjects with locally advanced or metastatic urothelial ...
| 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 |