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Locally Advanced or Metastatic Solid TumorsPhase 1NCT06545331

Study of XB010 in Subjects With Solid Tumors

A Phase 1 study testing XB010 and Pembrolizumab in people with Locally Advanced or Metastatic Solid Tumors and Esophageal Squamous Cell Cancer, run by Exelixis at 20 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
XB010 and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
396 participants
Where
20 sitesin 2 countries
Study dates
6 Aug 2024to 20 Oct 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  • 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.

Trial locations and contacts

20 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Exelixis Clinical Trials contact

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

druginfo@exelixis.com

Backup or International contact

650-837-7400

20 sites in 2 countries

United States16 sites, 15 recruiting

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

    Recruiting

  • NEXT Austin

    Austin, Texas, 78758

    Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Recruiting

  • Baylor University Medical Center

    Dallas, Texas, 75246

    Recruiting

  • Inova Schar Cancer

    Fairfax, Virginia, 22031

    Recruiting

  • NEXT Virginia

    Fairfax, Virginia, 22031

    Recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • Carolina BioOncology Institute

    Huntersville, North Carolina, 28078

    Recruiting

  • City of Hope Orange County Lennar Foundation Cancer Center

    Irvine, California, 91010

    Recruiting

  • UCLA Department of Medicine - Hematology/Oncology

    Los Angeles, California, 90095

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Recruiting

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

    Recruiting

  • Sarah Cannon Research Institute at Florida Cancer Specialists

    Orlando, Florida, 32827

    Recruiting

  • Siteman Cancer Center

    St Louis, Missouri, 63110

    Recruiting

  • Montefiore Medical Center - Montefiore Medical Park

    The Bronx, New York, 10461

    Recruiting

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

    Completed

Other trials in United States

United Kingdom4 sites, 4 recruiting

  • University Hospitals of Leicester NHS Trust

    Leicester, LE1 5WW

    Recruiting

  • Sarah Cannon Research Institute London

    London, W1G 6AD

    Recruiting

  • University College London Hospitals NHS Foundation Trust

    London, W1T 7HA

    Recruiting

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

    Recruiting

Other trials in United Kingdom

About this study

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

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.

Read the detailed description

This study consists of Dose-Escalation and Cohort-Expansion Stages. The Dose-Escalation Stage is designed to determine the maximum tolerated dose (MTD) and/or recommended dosage(s) for expansion (RDE[s]) of XB010 as a single agent, and to evaluate XB010 monotherapy RDE(s) in combination with pembrolizumab. The Cohort-Expansion Stage is designed to explore the clinical activity and further characterize the safety and tolerability of XB010 as monotherapy in multiple tumor-specific cohorts.

Being tested
XB010, Pembrolizumab
Medical subject headings
Esophageal Squamous Cell Carcinoma, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XB010Drug

    IV administration of XB010

  • PembrolizumabDrug

    IV administration of Pembrolizumab

Study groups in NCT06545331
Study groupRoleWhat they receive
XB010 Single-Agent Dose Escalation CohortsExperimentalXB010 will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects
Receives: Drug: XB010
XB010 + Pembrolizumab Dose Escalation CohortsExperimentalXB010+Pembrolizumab will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects
Receives: Drug: XB010; Drug: Pembrolizumab
XB010 Single-Agent Dose Expansion CohortsExperimentalXB010 will be administered at the recommended dose for expansion (RDE) every 3 weeks in the following tumor-specific cohorts: non-small cell lung cancer (NSCLC), hormone-receptor-positive breast cancer (HR+BC), head and neck squamous cell cancer (HNSCC), esophageal squamous cell cancer (ESCC), endometrial cancer (EC) and triple-negative breast cancer (TNBC)
Receives: Drug: XB010

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-Escalation Stage: Maximum tolerated dose (MTD) and/or Recommended dose(s) for Expansion [RDE(s)] for XB010

    To determine the MTD and/or RDE(s) for further evaluation of IV administration of XB010 alone and in combination therapy.

    Measured: 18 months

  2. Dose-Escalation Stage: Safety of XB010

    To evaluate the safety of XB010 alone and in combination therapy through the evaluation of incidence and severity of nonserious adverse events (AEs) and serious adverse events (SAEs)

    Measured: 18 months

  3. Dose-Escalation Stage: Duration of exposure of XB010 [Tolerability]

    To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the duration of exposure of each component

    Measured: 18 months

  4. Dose-Escalation Stage: Dose intensity of XB010 [Tolerability]

    To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the dose intensity of each component

    Measured: 18 months

  5. Cohort-Expansion Stage: Preliminary antitumor activity of XB010

    Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1

    Measured: 24 months

Secondary outcomes (14)

  1. Dose-Escalation Stage: Maximum Plasma Concentration (Cmax) of XB010

    To evaluate the maximum plasma concentration of XB010 alone and in combination.

    Measured: 18 Months

  2. Dose-Escalation Stage: Time to Maximum Plasma Concentration (Tmax) of XB010

    To evaluate the time to maximum plasma concentration of XB010 alone and in combination.

    Measured: 18 Months

  3. Dose-Escalation Stage: Clearance of XB010

    To evaluate the volume of plasma cleared of XB010 alone and in combination for a specified time period

    Measured: 18 Months

  4. Dose-Escalation Stage: Area Under the Plasma Concentration Curve (AUC) of XB010

    To measure the Area Under the Plasma Concentration Curve of XB010 alone and in combination

    Measured: 18 Months

  5. Dose-Escalation Stage: Minimum Plasma Concentration (Cmin) of XB010

    To evaluate the minimum plasma concentration of XB010 alone and in combination

    Measured: 18 Months

  6. Dose-Escalation Stage: Immunogenicity of XB010

    To assess the immunogenicity of XB010 alone and in combination as measured by anti-drug antibody (ADA) analysis

    Measured: 18 Months

  7. Cohort-Expansion Stage: Duration of exposure of XB010 [Tolerability]

    To evaluate the tolerability of XB010 through the evaluation of the duration of exposure

    Measured: 24 Months

  8. Cohort-Expansion Stage: Dose intensity of XB010 [Tolerability]

    To evaluate the tolerability of XB010 through the evaluation of the dose intensity

    Measured: 24 Months

  9. Cohort-Expansion Stage: Maximum Plasma Concentration (Cmax) of XB010

    To evaluate the maximum plasma concentration of XB010

    Measured: 24 Months

  10. Cohort-Expansion Stage: Time to Maximum Plasma Concentration (Tmax) of XB010

    To evaluate the time to maximum plasma concentration of XB010

    Measured: 24 Months

  11. Cohort-Expansion Stage: Clearance of XB010

    To evaluate the volume of plasma cleared of XB010 for a specified time period

    Measured: 24 Months

  12. Cohort-Expansion Stage: Area Under the Plasma Concentration Curve (AUC) of XB010

    To measure the Area Under the Plasma Concentration Curve of XB010

    Measured: 24 Months

  13. Cohort-Expansion Stage: Minimum Plasma Concentration (Cmin) of XB010

    To evaluate the minimum plasma concentration of XB010

    Measured: 24 Months

  14. Cohort-Expansion Stage: Immunogenicity of XB010

    To assess the immunogenicity of XB010 as measured by anti-drug antibody (ADA) analysis

    Measured: 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2024
  2. Study start6 Aug 2024
  3. Primary completion23 Nov 2026 (estimated)
  4. Study completion20 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
396 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06545331
Sponsor's protocol ID
XB010-101
Other IDs
1012465
Status last verified
Oct 2026
First submitted
29 Jul 2024
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing XB010 and Pembrolizumab in people with Locally Advanced or Metastatic Solid Tumors and Esophageal Squamous Cell Cancer, run by Exelixis at 20 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Exelixis Clinical Trials (1-888-EXELIXIS (888-393-5494), druginfo@exelixis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Escalation Stage: Maximum tolerated dose (MTD) and/or Recommended dose(s) for Expansion [RDE(s)] for XB010 (time frame: 18 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06545331.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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