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

RecruitingPhase 1

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

Sponsor: Exelixis · Participants: 303 · Started: May 1, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06952010

Locations in the U.S.

CaliforniaExelixis Clinical Site #5, San Francisco
ConnecticutExelixis Clinical Site #4, New Haven
FloridaExelixis Clinical Site #8, Tampa
MassachusettsExelixis Clinical Site #10, Boston
Exelixis Clinical Site #11, Boston
MissouriExelixis Clinical Site #6, St Louis
New YorkExelixis Clinical Site #7, New York
North CarolinaExelixis Clinical Site #1, Hickory
TennesseeExelixis Clinical Site #3, Nashville
TexasExelixis Clinical Site #9, Houston
Exelixis Clinical Site #2, San Antonio

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.