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Clinical Trials in the USA / NCT06952010
Recruiting Phase 1

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

NCT06952010 · tracked via the Priya Life Science USA tracker
Sponsor
Exelixis
Phase
Phase 1
Started
2025-05-01
Last updated
2026-06-24

Condition(s) studied

Solid TumorAdvanced Solid TumorMetastatic Solid TumorImmune Sensitive Tumor

Investigational drug(s) / intervention(s)

XB628Zanzalintinib

XB628: Intravenous infusion(s)

Zanzalintinib: Oral tablet(s)

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
Exelixis Clinical Site #5 San Francisco California Recruiting
Exelixis Clinical Site #4 New Haven Connecticut Recruiting
Exelixis Clinical Site #8 Tampa Florida Recruiting
Exelixis Clinical Site #10 Boston Massachusetts Recruiting
Exelixis Clinical Site #11 Boston Massachusetts Recruiting
Exelixis Clinical Site #6 St Louis Missouri Recruiting
Exelixis Clinical Site #7 New York New York Recruiting
Exelixis Clinical Site #1 Hickory North Carolina Recruiting
Exelixis Clinical Site #3 Nashville Tennessee Recruiting
Exelixis Clinical Site #9 Houston Texas Recruiting
Exelixis Clinical Site #2 San Antonio Texas Recruiting

More Exelixis trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06952010 on ClinicalTrials.gov ↗ ← All trials in the USA