Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
XB010 · 1 trial · 6 indications
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. * ...
XB010 is an investigational small molecule being developed for the treatment of locally advanced or metastatic solid tumors, including esophageal squamous cell cancer, head and neck squamous cell cancer, non-small cell lung cancer, hormone-receptor-positive breast cancer, and triple negative breast cancer.
XB010 targets the 5T4 protein, a tumor-associated antigen expressed on the surface of many solid tumor cells. By binding to 5T4, XB010 is designed to interfere with tumor cell function, though the exact mechanism of action is still under investigation in clinical trials.
XB010 is being developed by Exelixis, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol EXEL. The company is conducting clinical trials to evaluate the safety and efficacy of XB010 in patients with advanced solid tumors.
XB010 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and effectiveness in humans. The ongoing Phase 1 trial is actively recruiting participants.
XB010 is being studied in a Phase 1 clinical trial with the identifier NCT06545331, titled 'Study of XB010 in Subjects With Solid Tumors.' The trial is recruiting up to 396 participants in the United States and United Kingdom, and is open to adults aged 18 years and older.