A Study of XB628 Alone and in Combination With Zanzalintinib in Participants With Recurrent Advanced or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorExelixis
About this trial
This study consists of a Dose-Escalation stage and a Dose Expansion stage. The primary purpose of the dose escalation stage is to determine the maximum tolerated dose (MTD) and/or recommended dosage(s) for expansion (RDE\[s\]); and the dose expansion stage is to evaluate the preliminary antitumor activity of XB628 as a single agent and in combination with zanzalintinib.
Eligibility criteria
Qualifiers
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Minimum life expectancy of ≥ 12 weeks.
Have a recurrent advanced or metastatic solid tumor that is histologically or cytologically confirmed.
Adequate organ and marrow function.
Disqualifiers
Primary brain tumors or known active brain metastases.
Major surgery (eg, gastrointestinal surgery, removal or biopsy of brain metastasis) within 4 weeks before the first dose of study treatment.
Received radiation therapy within 1 week before the first dose of study treatment or clinically relevant ongoing complications from prior radiation therapy.
Received prior therapy targeting NK cells (eg, monalizumab).
Trial design
Treatments tested in this trial
- XB628
- Zanzalintinib
Treatment groups
303 Participants
are divided into 2 treatment groupsLocations
11California
Exelixis Clinical Site #594158, San Francisco United States
Connecticut
Exelixis Clinical Site #406520, New Haven United States
Florida
Exelixis Clinical Site #833612, Tampa United States
Massachusetts
Exelixis Clinical Site #1002114, Boston United States
Sponsors and collaborators
Exelixis
Lead sponsor
Source ClinicalTrials.gov