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A Study of XB628 Alone and in Combination With Zanzalintinib in Participants With Recurrent Advanced or Metastatic Solid Tumors
Trial Status: active
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.
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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06952010.
