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
Sponsor: Exelixis
This observational or N/A phase trial investigates Esophageal Squamous Cell Cancer and Head and Neck Squamous Cell Cancer and is currently actively recruiting participants. Exelixis leads this study, which shows 12 recorded versions since 2024 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)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.
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.
Status Flow
Change History
12 versions recorded-
Apr 16, 2026 — Present [daily]
Recruiting
Phase: PHASE1 → None
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Mar 2026 — Apr 2026 [monthly]
Recruiting PHASE1
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Feb 2026 — Mar 2026 [monthly]
Recruiting PHASE1
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Dec 2025 — Feb 2026 [monthly]
Recruiting PHASE1
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Nov 2025 — Dec 2025 [monthly]
Recruiting PHASE1
▶ Show 7 earlier versions
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Oct 2025 — Nov 2025 [monthly]
Recruiting PHASE1
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Sep 2025 — Oct 2025 [monthly]
Recruiting PHASE1
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Apr 2025 — Sep 2025 [monthly]
Recruiting PHASE1
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Feb 2025 — Apr 2025 [monthly]
Recruiting PHASE1
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Jan 2025 — Feb 2025 [monthly]
Recruiting PHASE1
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Dec 2024 — Jan 2025 [monthly]
Recruiting PHASE1
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Sep 2024 — Dec 2024 [monthly]
Recruiting PHASE1
First recorded
Aug 2024
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility 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.
Contact Information
- Exelixis
For direct contact, visit the study record on ClinicalTrials.gov .