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A Study of XB628 and Zanzalintinib for Advanced Solid Tumors

This study is testing XB628 alone and in combination with zanzalintinib for people with advanced or metastatic (spread to other parts of the body) solid tumors that have returned. The study has two main parts: first, to find the safest and most effective dose of the treatments, and then to see how well XB628 and zanzalintinib work against the cancer. To join, you must be 18 or older, have a solid tumor that can't be cured by surgery or radiation, and be generally well enough to participate (ECOG performance status of 0-1). The study aims to enroll 303 participants. We are looking for how many people experience side effects and how many see their tumors shrink.

Study design
This is an interventional study with a planned enrollment of 303 participants. It has two stages: a dose-escalation stage to find the right dose, and a dose-expansion stage to evaluate treatment effectiveness.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants in the dose escalation cohort will be monitored for side effects for up to 27 months. Participants in the dose expansion cohort will be monitored for how well the treatment works for up to 27 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06952010

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Exelixis
~303 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:XB628Zanzalintinib

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Escalation Cohort: Number of Participants with Dose Limiting Toxicities (DLTs)
Measured over 21 days
+2 more outcomes measured

Conditions

Solid Tumor
Advanced Solid Tumor
Metastatic Solid Tumor
Immune Sensitive Tumor

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Solid Neoplasm

NCT06952010

Where you'd take part

This study runs at 11 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Exelixis Clinical Site #1

    Hickory, North Carolinano site contact published

    Recruiting

  • Exelixis Clinical Site #10

    Boston, Massachusettsno site contact published

    Recruiting

  • Exelixis Clinical Site #11

    Boston, Massachusettsno site contact published

    Recruiting

  • Exelixis Clinical Site #2

    San Antonio, Texasno site contact published

    Recruiting

  • Exelixis Clinical Site #3

    Nashville, Tennesseeno site contact published

    Recruiting

  • Exelixis Clinical Site #4

    New Haven, Connecticutno site contact published

    Recruiting

  • Exelixis Clinical Site #5

    San Francisco, Californiano site contact published

    Recruiting

  • Exelixis Clinical Site #6

    St Louis, Missourino site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Exelixis

Who to contact

Exelixis Clinical Trials
[email protected]
1-888-EXELIXIS (888-393-5494)
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Dose Escalation Cohort: Number of Participants with Dose Limiting Toxicities (DLTs)21 days
  • Dose Escalation Cohort: Number of Participants With Treatment Emergent Adverse Events (TEAEs)Up to 27 months
  • Dose Expansion Cohort: Objective Response Rate (ORR)Up to 27 months