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NCT06952010PHASE1Recruiting

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

Exelixis

Start Date

5/1/2025

Completion Date

11/30/2027

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

BIOLOGICAL

XB628

DRUG

Zanzalintinib

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Conditions

Solid TumorAdvanced Solid TumorMetastatic Solid TumorImmune Sensitive Tumor

Locations

Exelixis Clinical Site #5

San Francisco, California 94158

United States

Exelixis Clinical Site #4

New Haven, Connecticut 06520

United States

Exelixis Clinical Site #8

Tampa, Florida 33612

United States

Exelixis Clinical Site #10

Boston, Massachusetts 02114

United States

Exelixis Clinical Site #11

Boston, Massachusetts 02114

United States

Exelixis Clinical Site #6

St Louis, Missouri 63108

United States

Exelixis Clinical Site #7

New York, New York 10029

United States

Exelixis Clinical Site #1

Hickory, North Carolina 28602

United States

Exelixis Clinical Site #3

Nashville, Tennessee 37203

United States

Exelixis Clinical Site #9

Houston, Texas 77030

United States

Exelixis Clinical Site #2

San Antonio, Texas 78229

United States