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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05651022 | Study of DECOY20 With or Without Tislelizumab in Patients With Advanced Solid Tumors | PHASE1 | ACTIVE NOT_RECRUITING | 120 | — | — | Feb 28, 2023 | Sep 30, 2027 | Jan 13, 2026 | 12 | United States |
A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medication. The relatedness and severity of treatment emergent adverse events will utilize the National Cancer Institute Common Toxicity Criteria for adverse events (NCI-CTCAE) for assessment.
The count and percentage of subjects with AEs and Treatment Emergent Adverse Events (TEAEs) will be assessed for all subjects.
The MTD is defined as the highest dose level at which no more than 1 out of 6 subjects experiences Dose Limiting Toxicity during the first 28 days after dosing of Decoy20.
The highest dose level that is declared to be safe and tolerable by the investigators and the sponsor.
| Arm | Type | Description |
|---|---|---|
| Part 1 | EXPERIMENTAL | A single dose of Decoy20 at a dose of 3 x 10\^7 KB or 7 x 10\^7 KB |
| Parts 2a and 2b | EXPERIMENTAL | Decoy20 administered weekly at a dose of 3 x 10\^7 KB or 7 x 10\^7 KB |
| Part 2c | EXPERIMENTAL | Decoy20 administered weekly at either 3 x 10\^7 KB or 7 x 10\^7 KB. Both will be administered with tislelizumab at 200mg Q3W. |
| Name | Type | Description |
|---|---|---|
| Decoy20 | DRUG | Decoy20 is a novel, systemically administered multiple Toll-like receptor (TLR) agonist-based cancer immunotherapy. |
| Tislelizumab | DRUG | Tislelizumab is a PD-1 inhibitor. |
Inclusion Criteria: 1. Males or females, age 18 years or older. 2. Histologically confirmed diagnosis of locally advanced or metastatic solid tumor. For Part 2, subjects must have one of the following locally advanced or metastatic tumor types: hepatocellular carcinoma (HCC), colorectal cancer (CRC...