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Monoclonal Antibodies

XB010 + Pembrolizumab for Cancer

Phase 1
Recruiting
Research Sponsored by Exelixis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older on the day of consent
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Summary

This trial is testing a new drug called XB010 to see if it is safe and effective in treating advanced or metastatic solid tumors. They will be testing XB010 alone and in combination with pembrol

Who is the study for?
This trial is for individuals with advanced or metastatic solid tumors when other treatments aren't available, are intolerable, or have stopped working. Specific eligibility details are not provided but typically include factors like age, health status, and type of tumor.
What is being tested?
The study investigates XB010 alone and combined with pembrolizumab to assess safety, tolerability, how the body processes it (PK), immune response (immunogenicity), and initial effectiveness against tumors in subjects whose cancer has spread.
What are the potential side effects?
While specific side effects are not listed here, common ones for similar cancer therapies may include fatigue, nausea, skin reactions at injection sites, immune-related issues such as inflammation in organs or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My cancer is confirmed, cannot be removed by surgery, and has spread or come back.
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I have samples of my tumor available for testing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cohort-Expansion Stage: Preliminary antitumor activity of XB010
Dose-Escalation Stage: Dose intensity of XB010 [Tolerability]
Dose-Escalation Stage: Duration of exposure of XB010 [Tolerability]
+2 more
Secondary study objectives
Cohort-Expansion Stage: Area Under the Plasma Concentration Curve (AUC) of XB010
Cohort-Expansion Stage: Clearance of XB010
Cohort-Expansion Stage: Dose intensity of XB010 [Tolerability]
+11 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: XB010 Single-Agent Dose Expansion CohortsExperimental Treatment1 Intervention
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), pancreatic ductal adenocarcinoma (PDAC), endometrial cancer (EC) and triple-negative breast cancer (TNBC)
Group II: XB010 Single-Agent Dose Escalation CohortsExperimental Treatment1 Intervention
XB010 will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects
Group III: XB010 + Pembrolizumab Dose Escalation CohortsExperimental Treatment2 Interventions
XB010+Pembrolizumab will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2070

Find a Location

Who is running the clinical trial?

ExelixisLead Sponsor
119 Previous Clinical Trials
19,569 Total Patients Enrolled
~233 spots leftby Nov 2026
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