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NCT Number: NCT06952010

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Exelixis Clinical Site #5, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

XB628

Biological

Intravenous infusion(s)

Zanzalintinib

Drug

Oral tablet(s)

Other names: XL092

Primary outcomes

  1. Dose Escalation Cohort: Number of Participants with Dose Limiting Toxicities (DLTs)

    Time frame: 21 days

  2. Dose Escalation Cohort: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 27 months

  3. Dose Expansion Cohort: Objective Response Rate (ORR)

    Time frame: Up to 27 months

Secondary outcomes

  1. Area Under the Concentration-time Curve (AUC) of XB628

    Time frame: 25 months

  2. Maximum Plasma Concentration (Cmax) of XB628

    Time frame: 25 months

  3. Time to Maximum Concentration (Tmax) of XB628

    Time frame: 25 months

  4. Elimination Half-life (T1/2) of XB628

    Time frame: 25 months

  5. Apparent Clearance (CL/F) of XB628

    Time frame: 25 months

  6. Trough Concentration (Ctrough) of XB628

    Time frame: 25 months

  7. Number of Participants with Antidrug Antibody (ADA) Response to XB628

    Time frame: 25 months

  8. RDE for XB628

    Time frame: 25 months

  9. Dose Expansion Cohort: Duration of Response (DOR)

    Time frame: 27 months

  10. Dose Expansion Cohort: Progression-Free Survival (PFS) of XB628

    Time frame: 27 months

Study contacts

Contact information is provided by the study sponsor or research team.

Backup or International

CONTACT

650-837-7400

Exelixis Clinical Trials

CONTACT

[email protected]

1-888-EXELIXIS (888-393-5494)

Sponsors and collaborators

Lead sponsor

Exelixis

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 30, 2025
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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