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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

396

Phase

  • 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

  • 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

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
Intervention / Treatment
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

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

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

Exelixis

Investigators

  • 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)

August 6, 2024

Primary Completion (Estimated)

November 23, 2026

Study Completion (Estimated)

October 20, 2027

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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