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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06545331 | Study of XB010 in Subjects With Solid Tumors | PHASE1 | RECRUITING | 396 | — | — | Aug 6, 2024 | Oct 20, 2027 | Apr 15, 2026 | 19 | United States, United Kingdom |
To determine the MTD and/or RDE(s) for further evaluation of IV administration of XB010 alone and in combination therapy.
To evaluate the safety of XB010 alone and in combination therapy through the evaluation of incidence and severity of nonserious adverse events (AEs) and serious adverse events (SAEs)
To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the duration of exposure of each component
To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the dose intensity of each component
Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1
| Arm | Type | Description |
|---|---|---|
| XB010 Single-Agent Dose Escalation Cohorts | EXPERIMENTAL | XB010 will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects |
| XB010 + Pembrolizumab Dose Escalation Cohorts | EXPERIMENTAL | XB010+Pembrolizumab will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects |
| XB010 Single-Agent Dose Expansion Cohorts | EXPERIMENTAL | XB010 will be administered at the recommended dose for expansion (RDE) every 3 weeks in the following tumor-specific cohorts: non-small cell lung cancer (NSCLC), hormone-receptor-positive breast cancer (HR+BC), head and neck squamous cell cancer (HNSCC), esophageal squamous cell cancer (ESCC), endometrial cancer (EC) and triple-negative breast cancer (TNBC) |
| Name | Type | Description |
|---|---|---|
| XB010 | DRUG | IV administration of XB010 |
| Pembrolizumab | DRUG | IV administration of Pembrolizumab |
* Age 18 years or older on the day of consent. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. * Adequate organ and marrow function. * Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent. * ...