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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04306900 | TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers | PHASE1 | COMPLETED | 185 | — | — | Mar 30, 2020 | Mar 27, 2024 | Jul 29, 2025 | 32 | United States, South Korea |
A DLT was defined as the occurrence of any of the following toxicities within the DLT Evaluation Period if judged by the Investigator and Sponsor to be possibly, probably, or definitely related to TTX-030 or budigalimab.
Number of study subjects experiencing adverse events (AEs) and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.
| Arm | Type | Description |
|---|---|---|
| Combo 1 | EXPERIMENTAL | TTX-030 plus budigalimab plus mFOLFOX6 |
| Combo 2 | EXPERIMENTAL | TTX-030 plus budigalimab plus docetaxel |
| Combo 3 | EXPERIMENTAL | TTX-030 plus mFOLFOX6 |
| Combo 4 | EXPERIMENTAL | TTX-030 plus pembrolizumab |
| Combo 5 | EXPERIMENTAL | TTX-030 plus budigalimab (selected tumors evaluated in expansion) |
| Combo 6 | EXPERIMENTAL | TTX-030 plus budigalimab plus nab-paclitaxel + gemcitabine |
| Combo 7 | EXPERIMENTAL | TTX-030 plus nab-paclitaxel + gemcitabine |
| Combo 8 | EXPERIMENTAL | Budigalimab plus mFOLFOX6 |
| Name | Type | Description |
|---|---|---|
| TTX-030, budigalimab and mFOLFOX6 | COMBINATION_PRODUCT | Dose and schedule per protocol |
| TTX-030, budigalimab and docetaxel | COMBINATION_PRODUCT | Dose and schedule per protocol |
| TTX-030 and mFOLFOX6 | COMBINATION_PRODUCT | Dose and schedule per protocol |
| TTX-030 and budigalimab | COMBINATION_PRODUCT | Dose and schedule per protocol |
| TTX-030, budigalimab, nab-paclitaxel and gemcitabine | COMBINATION_PRODUCT | Dose and schedule per protocol |
| TTX-030 and pembrolizumab | COMBINATION_PRODUCT | Dose and schedule per protocol |
| TTX-030, nab-paclitaxel and gemcitabine | COMBINATION_PRODUCT | Dose and schedule per protocol |
| Budigalimab and mFOLFOX6 | COMBINATION_PRODUCT | Dose and schedule per protocol |
Abbreviated Inclusion Criteria: 1. Age 18 years or older, is willing and able to provide informed consent 2. Histologically confirmed diagnosis of unresectable or metastatic solid tumor malignancy in selected tumor types 3. Life expectancy \> 12 weeks 4. ECOG performance status of 0-1 Abbreviated ...