NCT02665416

Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of Selicrelumab (RO7009789) With Vanucizumab or Bevacizumab in Participants With Metastatic Solid Tumors

An Open-Label, Multicenter, Dose Escalation Phase Ib Study With Expansion Cohorts to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Therapeutic Activity of RO7009789 (CD40 Agonistic Monoclonal Antibody) in Combination With Vanucizumab (Anti-Ang2 and Anti-VEGF Bi-Specific Monoclonal Antibody, Part I) or Bevacizumab (Anti-VEGF Monoclonal Antibody, Part II) in Patients With Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label, two-part study is designed to assess the safety, PK, PD, and therapeutic activity of Selicrelumab in combination with vanucizumab or bevacizumab in participants with metastatic solid tumors not amenable to standard treatment. Part I (dose escalation) is designed to establish the maximum tolerated dose (MTD) of Selicrelumab in this combination. Part II (expansion) is intended to characterize the safety and tolerability of Selicrelumab in combination with bevacizumab among indication-specific cohorts and to confirm the recommended dose.

Conditions

• Advanced/Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	Selicrelumab	Selicrelumab will be provided as concentrate for solution to be administered via SC injection
DRUG	Vanucizumab	Vanucizumab will be provided as solution to be administered via IV infusion.
DRUG	Bevacizumab	Bevacizumab will be administered via IV infusion.

Timeline

• Start date: 2016-01-25
• Primary completion: 2019-10-30
• Completion: 2019-10-30
• First posted: 2016-01-27
• Last updated: 2020-04-07

Locations

16 sites across 7 countries: United States, Belgium, Canada, Denmark, Italy, Netherlands, Spain

Regulatory

• FDA-regulated drug study