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NCT06545331RecruitingPhase 1

Study of XB010 in Subjects With Solid Tumors

A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors

Source: ClinicalTrials.gov · Last updated 30 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
396 (estimated)
First submitted
29 Jul 2024
Start date
6 Aug 2024
Primary completion date
23 Nov 2026
Lead sponsor
Exelixis
NCT number
NCT06545331

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 396
  • From 6 Aug 2024 to the primary completion date, 23 Nov 2026
  • 20 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospitals of Leicester NHS Trust
Coordinator of this site? Confirm its status
LeicesterUnited KingdomRecruiting
Sarah Cannon Research Institute London
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LondonUnited KingdomRecruiting
University College London Hospitals NHS Foundation Trust
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LondonUnited KingdomRecruiting
The Christie NHS Foundation Trust
Coordinator of this site? Confirm its status
ManchesterUnited KingdomRecruiting
Winship Cancer Institute
Coordinator of this site? Confirm its status
AtlantaUnited StatesRecruiting
NEXT Austin
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AustinUnited StatesRecruiting
University of Chicago Medical Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
Baylor University Medical Center
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DallasUnited StatesRecruiting
Inova Schar Cancer
Coordinator of this site? Confirm its status
FairfaxUnited StatesRecruiting
NEXT Virginia
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FairfaxUnited StatesRecruiting
University of Texas - MD Anderson Cancer Center
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HoustonUnited StatesRecruiting
Carolina Biooncology Institute
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HuntersvilleUnited StatesCompleted
City of Hope Orange County Lennar Foundation Cancer Center
Coordinator of this site? Confirm its status
IrvineUnited StatesRecruiting
UCLA Department of Medicine - Hematology/Oncology
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Los AngelesUnited StatesRecruiting
SCRI Oncology Partners
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NashvilleUnited StatesRecruiting
Stephenson Cancer Center
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Oklahoma CityUnited StatesRecruiting
Sarah Cannon Research Institute at Florida Cancer Specialists
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OrlandoUnited StatesRecruiting
Siteman Cancer Center
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St LouisUnited StatesRecruiting
Montefiore Medical Center- Montefiore Medical Park
Coordinator of this site? Confirm its status
The BronxUnited StatesRecruiting
Georgetown University Medical Center
Coordinator of this site? Confirm its status
Washington D.C.United StatesCompleted

This page is information, not medical advice. Discuss any trial with your doctor.