Study of XB010 in Subjects With Solid Tumors

NCT06545331 · tracked via the Priya Life Science USA tracker

Sponsor

Exelixis

Phase

Phase 1

Started

2024-08-06

Last updated

2026-10-30

Condition(s) studied

Locally Advanced or Metastatic Solid TumorsEsophageal Squamous Cell CancerHead and Neck Squamous Cell CancerNSCLC (Non-small Cell Lung Cancer)Hormone-receptor-positive Breast CancerTriple Negative Breast Cancer (TNBC)

Investigational drug(s) / intervention(s)

XB010Pembrolizumab →

XB010: IV administration of XB010

Pembrolizumab: IV administration of Pembrolizumab

Study 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 intolerable or no longer effective.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

* 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.

Primary outcome measure(s)

Dose-Escalation Stage: Maximum tolerated dose (MTD) and/or Recommended dose(s) for Expansion [RDE(s)] for XB010 — 18 months
To determine the MTD and/or RDE(s) for further evaluation of IV administration of XB010 alone and in combination therapy.
Dose-Escalation Stage: Safety of XB010 — 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)
Dose-Escalation Stage: Duration of exposure of XB010 [Tolerability] — 18 months
To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the duration of exposure of each component
Dose-Escalation Stage: Dose intensity of XB010 [Tolerability] — 18 months
To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the dose intensity of each component
Cohort-Expansion Stage: Preliminary antitumor activity of XB010 — 24 months
Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1

Trial sites (20)

Facility	City	Region	Status
City of Hope Orange County Lennar Foundation Cancer Center	Irvine	California	Recruiting
UCLA Department of Medicine - Hematology/Oncology	Los Angeles	California	Recruiting
Georgetown University Medical Center	Washington D.C.	District of Columbia	Completed
Sarah Cannon Research Institute at Florida Cancer Specialists	Orlando	Florida	Recruiting
Winship Cancer Institute	Atlanta	Georgia	Recruiting
University of Chicago Medical Center	Chicago	Illinois	Recruiting
Siteman Cancer Center	St Louis	Missouri	Recruiting
Montefiore Medical Center - Montefiore Medical Park	The Bronx	New York	Recruiting
Carolina BioOncology Institute	Huntersville	North Carolina	Completed
Stephenson Cancer Center	Oklahoma City	Oklahoma	Recruiting
SCRI Oncology Partners	Nashville	Tennessee	Recruiting
NEXT Austin	Austin	Texas	Recruiting
Baylor University Medical Center	Dallas	Texas	Recruiting
University of Texas MD Anderson Cancer Center	Houston	Texas	Recruiting
Inova Schar Cancer	Fairfax	Virginia	Recruiting
NEXT Virginia	Fairfax	Virginia	Recruiting
University Hospitals of Leicester NHS Trust	Leicester	United Kingdom	Recruiting
Sarah Cannon Research Institute London	London	United Kingdom	Recruiting
University College London Hospitals NHS Foundation Trust	London	United Kingdom	Recruiting
The Christie NHS Foundation Trust	Manchester	United Kingdom	Recruiting

On this site

📄 Keytruda (pembrolizumab) drug profile →

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Other trials for the same condition

A Phase 1, First-in-Human (FIH), Open-Label, Dose-Escalation and Dose Expansion Study of the Peptide Drug Conjugate (PDC), TS-104, as a Monotherapy in Subjects With Select Advanced Solid Tumors Recruiting

Phase 1 Study of a Self-amplifying RNA Vaccine (ITI-5000) in Stage 2-3 Triple Negative Breast Cancer Recruiting

PQ203 in Advanced Malignant Tumors Including Triple Negative Breast Cancer Recruiting

Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors Active, not recruiting

A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06545331 on ClinicalTrials.gov ↗ ← All trials in the USA