A Study of XB628 Alone and in Combination With Zanzalintinib in Participants With Recurrent Advanced or Metastatic Solid Tumors

Summary

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

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.

Conditions5

Interventions2

Locations11 sites

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