NCT03845166

A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors

A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 325 (actual)
• Sponsor: Exelixis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label, dose-escalation and expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect on biomarkers of XL092 administered alone, in combination with atezolizumab, and in combination with avelumab to subjects with advanced solid tumors.

Conditions

• Neoplasm Malignant
• Renal Cell Carcinoma
• Hormone Receptor Positive Breast Carcinoma
• Metastatic Castration-resistant Prostate Cancer
• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	XL092	oral doses of XL092
DRUG	Atezolizumab	Supplied as 1200 mg/20 mL vials; administered as a 1200 mg IV infusion once every 3 weeks (q3w)
DRUG	Avelumab	Supplied as 200 mg/10 mL vials; administered as an 800 mg IV infusion once every 2 weeks (q2w)

Timeline

• Start date: 2019-03-20
• Primary completion: 2026-08-31
• Completion: 2027-05-31
• First posted: 2019-02-19
• Last updated: 2024-11-19

Locations

86 sites across 10 countries: United States, Australia, Belgium, Czechia, France, Germany, Italy, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study