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A Study of XB628 Alone and in Combination With Zanzalintinib in Participants With Recurrent Advanced or Metastatic Solid Tumors
A Phase 1 Dose Escalation and Expansion Study of XB628 as a Single Agent and in Combination With Zanzalintinib in Participants With Advanced or Metastatic Solid Tumors
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Key Inclusion Criteria: * 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. * Not amenable to curative treatment with surgery or radiation. * Received at least 1 line of prior systemic anticancer therapy in the recurrent or metastatic setting. * Acceptable alternative therapy was received, refused, intolerable, or no longer effective. * Capable of understanding and complying with the protocol requirements and provide signed informed consent according to the protocol and local requirements. Key Exclusion Criteria * 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). * A woman of childbearing potential has a positive serum pregnancy test within 7 days prior to study treatment. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
About the study
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.
What is being tested
- XB628 (biological)
- Zanzalintinib (drug)
Sponsor: Exelixis · Participants: 303 · Started: May 1, 2025
Contact the study team
- Exelixis Clinical Trials · Phone: 1-888-EXELIXIS (888-393-5494)
- Backup or International · Phone: 650-837-7400
Official record on ClinicalTrials.gov — NCT06952010
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.