Study of XB010 in Subjects With Solid Tumors (DELTA-101)

April 10, 2026 updated by: Exelixis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
396

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Exelixis Clinical Trials
  • Phone Number: 1-888-EXELIXIS (888-393-5494)
  • Email: druginfo@exelixis.com

Study Contact Backup

  • Name: Backup or International
  • Phone Number: 650-837-7400

Study Locations

  • United Kingdom
    • England
      • Leicester, England, United Kingdom, LE1 5WW
        • Recruiting
        • Exelixis Clinical Site #17
      • London, England, United Kingdom, W1G 6AD
        • Recruiting
        • Exelixis Clinical Site #13
      • London, England, United Kingdom, W1T 7HA
        • Recruiting
        • Exelixis Clinical Site #16
      • Manchester, England, United Kingdom, M20 4BX
        • Recruiting
        • Exelixis Clinical Site #14
  • United States
    • California
      • Irvine, California, United States, 92618
        • Recruiting
        • Exelixis Clinical Site #4
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Exelixis Clinical Site #19
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • Exelixis Clinical Site #10
    • Florida
      • Orlando, Florida, United States, 32827
        • Recruiting
        • Exelixis Clinical Site #18
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Exelixis Clinical Site #12
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • Exelixis Clinical Site #15
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Exelixis Clinical Site #5
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Exelixis Clinical Site #3
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • Exelixis Clinical Site #6
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Exelixis Clinical Site #9
    • Texas
      • Austin, Texas, United States, 78758
        • Recruiting
        • Exelixis Clinical Site #1
      • Dallas, Texas, United States, 74246
        • Recruiting
        • Exelixis Clinical Site #7
      • Houston, Texas, United States, 77030
        • Recruiting
        • Exelixis Clinical Site #8
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Exelixis Clinical Site #2
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Exelixis Clinical Site #11

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: XB010 Single-Agent Dose Escalation Cohorts
XB010 will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects
Drug: XB010
IV administration of XB010
Experimental: XB010 + Pembrolizumab Dose Escalation Cohorts
XB010+Pembrolizumab will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects
Drug: XB010
IV administration of XB010
Drug: Pembrolizumab
IV administration of Pembrolizumab
Experimental: XB010 Single-Agent Dose Expansion Cohorts
XB010 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)
Drug: XB010
IV administration of XB010

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dose-Escalation Stage: Maximum tolerated dose (MTD) and/or Recommended dose(s) for Expansion [RDE(s)] for XB010
Time Frame: 18 months
To determine the MTD and/or RDE(s) for further evaluation of IV administration of XB010 alone and in combination therapy.
18 months
Dose-Escalation Stage: Safety of XB010
Time Frame: 18 months
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)
18 months
Dose-Escalation Stage: Duration of exposure of XB010 [Tolerability]
Time Frame: 18 months
To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the duration of exposure of each component
18 months
Dose-Escalation Stage: Dose intensity of XB010 [Tolerability]
Time Frame: 18 months
To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the dose intensity of each component
18 months
Cohort-Expansion Stage: Preliminary antitumor activity of XB010
Time Frame: 24 months
Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dose-Escalation Stage: Maximum Plasma Concentration (Cmax) of XB010
Time Frame: 18 Months
To evaluate the maximum plasma concentration of XB010 alone and in combination.
18 Months
Dose-Escalation Stage: Time to Maximum Plasma Concentration (Tmax) of XB010
Time Frame: 18 Months
To evaluate the time to maximum plasma concentration of XB010 alone and in combination.
18 Months
Dose-Escalation Stage: Clearance of XB010
Time Frame: 18 Months
To evaluate the volume of plasma cleared of XB010 alone and in combination for a specified time period
18 Months
Dose-Escalation Stage: Area Under the Plasma Concentration Curve (AUC) of XB010
Time Frame: 18 Months
To measure the Area Under the Plasma Concentration Curve of XB010 alone and in combination
18 Months
Dose-Escalation Stage: Minimum Plasma Concentration (Cmin) of XB010
Time Frame: 18 Months
To evaluate the minimum plasma concentration of XB010 alone and in combination
18 Months
Dose-Escalation Stage: Immunogenicity of XB010
Time Frame: 18 Months
To assess the immunogenicity of XB010 alone and in combination as measured by anti-drug antibody (ADA) analysis
18 Months
Cohort-Expansion Stage: Duration of exposure of XB010 [Tolerability]
Time Frame: 24 Months
To evaluate the tolerability of XB010 through the evaluation of the duration of exposure
24 Months
Cohort-Expansion Stage: Dose intensity of XB010 [Tolerability]
Time Frame: 24 Months
To evaluate the tolerability of XB010 through the evaluation of the dose intensity
24 Months
Cohort-Expansion Stage: Maximum Plasma Concentration (Cmax) of XB010
Time Frame: 24 Months
To evaluate the maximum plasma concentration of XB010
24 Months
Cohort-Expansion Stage: Time to Maximum Plasma Concentration (Tmax) of XB010
Time Frame: 24 Months
To evaluate the time to maximum plasma concentration of XB010
24 Months
Cohort-Expansion Stage: Clearance of XB010
Time Frame: 24 Months
To evaluate the volume of plasma cleared of XB010 for a specified time period
24 Months
Cohort-Expansion Stage: Area Under the Plasma Concentration Curve (AUC) of XB010
Time Frame: 24 Months
To measure the Area Under the Plasma Concentration Curve of XB010
24 Months
Cohort-Expansion Stage: Minimum Plasma Concentration (Cmin) of XB010
Time Frame: 24 Months
To evaluate the minimum plasma concentration of XB010
24 Months
Cohort-Expansion Stage: Immunogenicity of XB010
Time Frame: 24 Months
To assess the immunogenicity of XB010 as measured by anti-drug antibody (ADA) analysis
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Exelixis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, Exelixis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 6, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 23, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 20, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XB010-101
  • 1012465 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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