NCT04925284

Study of XB002 in Subjects With Solid Tumors (JEWEL-101)

A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XB002 as Single-Agent and Combination Therapy in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 269 (actual)
• Sponsor: Exelixis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label, multicenter, dose-escalation and expansion study evaluating the safety, tolerability, PK, pharmacodynamics, and clinical antitumor activity of XB002 administered IV q3w alone and in combination with nivolumab or bevacizumab to subjects with advanced solid tumors.

Conditions

• Non Small Cell Lung Cancer
• Cervical Cancer
• SCCHN
• Pancreatic Cancer
• Esophageal SCC
• Metastatic Castration-resistant Prostate Cancer
• Triple Negative Breast Cancer
• Hormone Receptor-positive Breast Cancer
• Epithelial Ovarian Cancer
• Endometrial Cancer
• Tissue Factor-Expressing Solid Tumors

Interventions

Type	Name	Description
DRUG	XB002	IV administration of XB002
DRUG	Nivolumab	IV administration of Nivolumab
DRUG	Bevacizumab	IV administration of bevacizumab

Timeline

• Start date: 2021-06-07
• Primary completion: 2025-03-10
• Completion: 2025-03-10
• First posted: 2021-06-14
• Last updated: 2025-04-04

Locations

95 sites across 9 countries: United States, Australia, Belgium, France, Italy, Netherlands, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study