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Study of XB010 in Subjects With Solid Tumors

RECRUITINGPhase 1Sponsored by Exelixis
Actively Recruiting
PhasePhase 1
SponsorExelixis
Started2024-08-06
Est. completion2026-11-23
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations13 sites

Summary

This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are intolerable or no longer effective.

Eligibility

Age: 18 Years+Healthy volunteers accepted
* Age 18 years or older on the day of consent.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
* Adequate organ and marrow function.
* Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent.

  * The Cohort Expansion stage will enroll subjects with multiple tumor types (non-small cell lung cancer, hormone-receptor-positive breast cancer, head and neck cancer, esophageal squamous cell, triple-negative breast cancer).
* Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.

Conditions9

Breast CancerCancerEsophageal Squamous Cell CancerHead and Neck Squamous Cell CancerHormone Receptor Positive Breast CancerLocally Advanced or Metastatic Solid TumorsLung CancerNSCLC (Non-small Cell Lung Cancer)Triple Negative Breast Cancer (TNBC)

Locations13 sites

Exelixis Clinical Site #4
Irvine, California, 92618
Exelixis Clinical Site #10
Washington D.C., District of Columbia, 20007
Exelixis Clinical Site #12
Atlanta, Georgia, 30322
Exelixis Clinical Site #15
Chicago, Illinois, 60637
Exelixis Clinical Site #5
St Louis, Missouri, 63110

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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