NCT04857138

A Study to Evaluate Safety, Pharmacokinetics and Anti-Tumor Activity of RO7300490, as Single Agent or in Combination With Atezolizumab in Participants With Advanced Solid Tumors

An Open-Label, Multicenter, Dose-Escalation and Expansion, Phase I Study to Evaluate Safety, Pharmacokinetics, And Anti-Tumor Activity of RO7300490, A Fibroblast Activation Protein-α (FAP) Targeted CD40 Agonist, as Single Agent or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate the safety, pharmacokinetics and anti-tumor activity of RO7300490 as a single agent or in combination with atezolizumab. The study will consist of 3 parts: \[Part 1\] Dose-Escalation of RO7300490 as a single agent; \[Part 2\] Dose-Escalation of RO7300490 in combination with atezolizumab and \[Part 3\] Dose-Expansion of RO7300490 in combination with atezolizumab in selected cancer types.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	RO7300490	Participants will receive RO7300490, as described in the Arm Descriptions.
DRUG	Atezolizumab	Participants will receive Atezolizumab, as described in the Arm Descriptions.

Timeline

• Start date: 2021-05-18
• Primary completion: 2024-01-18
• Completion: 2024-01-18
• First posted: 2021-04-23
• Last updated: 2024-02-05

Locations

11 sites across 5 countries: Denmark, France, South Korea, Spain, United Kingdom