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Study of XB010 in Subjects With Solid Tumors

NCT ID: NCT06545331

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

396 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-06

Study Completion Date

2027-10-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Locally Advanced or Metastatic Solid Tumors Esophageal Squamous Cell Cancer Head and Neck Squamous Cell Cancer NSCLC (Non-small Cell Lung Cancer) Hormone-receptor-positive Breast Cancer Triple Negative Breast Cancer (TNBC)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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XB010 Single-Agent Dose Escalation Cohorts

XB010 will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects

Group Type EXPERIMENTAL

XB010

Intervention Type DRUG

IV administration of XB010

XB010 + Pembrolizumab Dose Escalation Cohorts

XB010+Pembrolizumab will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects

Group Type EXPERIMENTAL

XB010

Intervention Type DRUG

IV administration of XB010

Pembrolizumab

Intervention Type DRUG

IV administration of Pembrolizumab

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)

Group Type EXPERIMENTAL

XB010

Intervention Type DRUG

IV administration of XB010

Interventions

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XB010

IV administration of XB010

Intervention Type DRUG

Pembrolizumab

IV administration of Pembrolizumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Exelixis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Exelixis

Locations

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Exelixis Clinical Site #4

Irvine, California, United States

Site Status RECRUITING

Exelixis Clinical Site #10

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Exelixis Clinical Site #12

Atlanta, Georgia, United States

Site Status RECRUITING

Exelixis Clinical Site #15

Chicago, Illinois, United States

Site Status RECRUITING

Exelixis Clinical Site #5

St Louis, Missouri, United States

Site Status RECRUITING

Exelixis Clinical Site #3

Huntersville, North Carolina, United States

Site Status RECRUITING

Exelixis Clinical Site #6

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Exelixis Clinical Site #9

Nashville, Tennessee, United States

Site Status RECRUITING

Exelixis Clinical Site #1

Austin, Texas, United States

Site Status RECRUITING

Exelixis Clinical Site #7

Dallas, Texas, United States

Site Status RECRUITING

Exelixis Clinical Site #8

Houston, Texas, United States

Site Status RECRUITING

Exelixis Clinical Site #11

Fairfax, Virginia, United States

Site Status RECRUITING

Exelixis Clinical Site #2

Fairfax, Virginia, United States

Site Status RECRUITING

Exelixis Clinical Site #13

London, England, United Kingdom

Site Status RECRUITING

Exelixis Clinical Site #14

Manchester, England, United Kingdom

Site Status RECRUITING

Countries

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United States United Kingdom

Central Contacts

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Exelixis Clinical Trials

Role: CONTACT

[email protected]
1-888-EXELIXIS (888-393-5494)

Backup or International

Role: CONTACT

650-837-7400

Other Identifiers

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XB010-101

Identifier Type: -

Identifier Source: org_study_id

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