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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04432857 | AN0025 and Pembrolizumab Combination in Advanced Solid Tumors | PHASE1 | ACTIVE NOT_RECRUITING | 63 | — | — | Aug 20, 2020 | Jan 30, 2025 | Jun 27, 2024 | 6 | United States, France |
Number of participants with Dose Limiting Toxicities (DLTs)
| Arm | Type | Description |
|---|---|---|
| Ph1a: Urothelial carcinoma of the bladder and NSCLC | EXPERIMENTAL | Patients will receive AN0025 orally once daily (QD); Pembrolizumab, 200mg as an intravenous infusion over 30 minutes every 3 weeks. |
| Phase 1b: Urothelial carcinoma of the bladder | EXPERIMENTAL | Patients will receive AN0025 orally once daily (QD); Pembrolizumab, 200mg as an intravenous infusion over 30 minutes every 3 weeks. |
| Phase 1b: Non-Small Cell Lung Cancer (NSCLC) | EXPERIMENTAL | Patients will receive AN0025 orally once daily (QD); Pembrolizumab, 200mg as an intravenous infusion over 30 minutes every 3 weeks. |
| Phase 1b: Triple-negative breast cancer (TNBC) | EXPERIMENTAL | Patients will receive AN0025 orally once daily (QD); Pembrolizumab, 200mg as an intravenous infusion over 30 minutes every 3 weeks. |
| Phase 1b: Cervical | EXPERIMENTAL | Patients will receive AN0025 orally once daily (QD); Pembrolizumab, 200mg as an intravenous infusion over 30 minutes every 3 weeks. |
| Phase 1b: Microsatellite Stable (MSS) Colorectal Cancer (CRC) | EXPERIMENTAL | Patients will receive AN0025 orally once daily (QD); Pembrolizumab, 200mg as an intravenous infusion over 30 minutes every 3 weeks. |
| Name | Type | Description |
|---|---|---|
| AN0025 | DRUG | oral administration |
| Pembrolizumab | DRUG | Infusion |
Inclusion Criteria: 1. Age ≥18 years at the time of informed consent. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 3. Life expectancy ≥3 months. 4. Diagnosed with histologically confirmed locally advanced and nonresectable, or metastatic disease. Patients diagnosed...