NCT01693562

A Phase 1/2 Study to Evaluate MEDI4736

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1,022 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, first-time-in-human study with a standard 3+3 dose-escalation phase in participants with advanced solid tumors followed by an expansion phase in participants with advanced solid tumors. An exploration cohort has been added to determine the safety using every 4 weeks (Q4W) dosing.

Detailed description

A dose-escalation and dose-expansion study of MEDI4736 (a monoclonal antibody that targets programmed cell death ligand-1 (PD-L1)) will evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity (IM), and antitumor activity of MEDI4736 in adult participants with solid tumors. A dose exploration cohort will look at the safety profile of Q4W dosing of MEDI4736.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	MEDI4736	Participants will receive IV infusion of MEDI4736 for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Timeline

• Start date: 2012-09-05
• Primary completion: 2020-02-28
• Completion: 2020-02-28
• First posted: 2012-09-26
• Last updated: 2021-05-13
• Results posted: 2021-05-13

Locations

79 sites across 9 countries: United States, Belgium, Canada, France, Germany, Italy, South Korea, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study