Study of XB010 in Subjects With Solid Tumors
A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors
2 other identifiers
interventional
396
2 countries
19
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2024
Typical duration for phase_1
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2024
CompletedStudy Start
First participant enrolled
August 6, 2024
CompletedFirst Posted
Study publicly available on registry
August 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 20, 2027
April 15, 2026
April 1, 2026
2.3 years
July 29, 2024
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
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.
18 months
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)
18 months
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
18 months
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
18 months
Cohort-Expansion Stage: Preliminary antitumor activity of XB010
Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1
24 months
Secondary Outcomes (14)
Dose-Escalation Stage: Maximum Plasma Concentration (Cmax) of XB010
18 Months
Dose-Escalation Stage: Time to Maximum Plasma Concentration (Tmax) of XB010
18 Months
Dose-Escalation Stage: Clearance of XB010
18 Months
Dose-Escalation Stage: Area Under the Plasma Concentration Curve (AUC) of XB010
18 Months
Dose-Escalation Stage: Minimum Plasma Concentration (Cmin) of XB010
18 Months
- +9 more secondary outcomes
Study Arms (3)
XB010 Single-Agent Dose Escalation Cohorts
EXPERIMENTALXB010 will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects
XB010 + Pembrolizumab Dose Escalation Cohorts
EXPERIMENTALXB010+Pembrolizumab will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects
XB010 Single-Agent Dose Expansion Cohorts
EXPERIMENTALXB010 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)
Interventions
IV administration of XB010
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Exelixislead
Study Sites (19)
Exelixis Clinical Site #4
Irvine, California, 92618, United States
Exelixis Clinical Site #19
Los Angeles, California, 90095, United States
Exelixis Clinical Site #10
Washington D.C., District of Columbia, 20007, United States
Exelixis Clinical Site #18
Orlando, Florida, 32827, United States
Exelixis Clinical Site #12
Atlanta, Georgia, 30322, United States
Exelixis Clinical Site #15
Chicago, Illinois, 60637, United States
Exelixis Clinical Site #5
St Louis, Missouri, 63110, United States
Exelixis Clinical Site #3
Huntersville, North Carolina, 28078, United States
Exelixis Clinical Site #6
Oklahoma City, Oklahoma, 73104, United States
Exelixis Clinical Site #9
Nashville, Tennessee, 37203, United States
Exelixis Clinical Site #1
Austin, Texas, 78758, United States
Exelixis Clinical Site #7
Dallas, Texas, 74246, United States
Exelixis Clinical Site #8
Houston, Texas, 77030, United States
Exelixis Clinical Site #11
Fairfax, Virginia, 22031, United States
Exelixis Clinical Site #2
Fairfax, Virginia, 22031, United States
Exelixis Clinical Site #17
Leicester, England, LE1 5WW, United Kingdom
Exelixis Clinical Site #13
London, England, W1G 6AD, United Kingdom
Exelixis Clinical Site #16
London, England, W1T 7HA, United Kingdom
Exelixis Clinical Site #14
Manchester, England, M20 4BX, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Exelixis
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2024
First Posted
August 9, 2024
Study Start
August 6, 2024
Primary Completion (Estimated)
November 23, 2026
Study Completion (Estimated)
October 20, 2027
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share