NCT06545331

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 396 (estimated)
• Sponsor: Exelixis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• 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)

Interventions

Type	Name	Description
DRUG	XB010	IV administration of XB010
DRUG	Pembrolizumab	IV administration of Pembrolizumab

Timeline

• Start date: 2024-08-06
• Primary completion: 2026-11-23
• Completion: 2027-10-20
• First posted: 2024-08-09
• Last updated: 2026-04-15

Locations

19 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study