Study of XB010 for Advanced Solid Tumors
This study is testing a new drug called XB010, both alone and with pembrolizumab, for people with advanced solid tumors like esophageal, head and neck, non-small cell lung, or hormone-receptor-positive breast cancer. You might be able to join if your cancer is inoperable, locally advanced, metastatic, or has come back, and if other treatments haven't worked or you can't tolerate them. The main goals are to find a safe and effective dose of XB010 and to see how well it's tolerated over 18 months. You need to be at least 18 years old and have good overall health and organ function to participate. The study is currently recruiting about 396 participants.
- Study design
- This is an interventional study with two stages: Dose-Escalation and Cohort-Expansion. It aims to determine safe dosages and then explore the drug's activity in specific tumor types.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints for safety and tolerability are measured at 18 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of XB010 in Subjects With Solid Tumors
At a glance
Conditions
Where it's being run
20 sites across 13 statesStudy leadership
- Study Director · STUDY_DIRECTOR · Exelixis
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Dose-Escalation Stage: Maximum tolerated dose (MTD) and/or Recommended dose(s) for Expansion [RDE(s)] for XB01018 months
To determine the MTD and/or RDE(s) for further evaluation of IV administration of XB010 alone and in combination therapy.
- Dose-Escalation Stage: Safety of XB01018 months
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)
- Dose-Escalation Stage: Duration of exposure of XB010 [Tolerability]18 months
To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the duration of exposure of each component
- Dose-Escalation Stage: Dose intensity of XB010 [Tolerability]18 months
To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the dose intensity of each component
- Cohort-Expansion Stage: Preliminary antitumor activity of XB01024 months
Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1