NCT02221960

A Phase 1 Study to Evaluate MEDI6383 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors

A Phase 1 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI6383 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

To evaluate MEDI6383 when given alone or together with MEDI4736 in adult subjects with recurrent or metastatic solid tumors.

Detailed description

This is a Phase 1, multicenter, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and antitumor activity of MEDI6383 alone and in combination with MEDI4736 in adult subjects with recurrent or metastatic solid tumors.

Conditions

• Recurrent or Metastatic Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	MEDI6383	Subjects will receive MEDI6383 until disease progression or adverse event.
BIOLOGICAL	MEDI6383 and MEDI4736	Subjects will recieve MEDI6383 and MEDI4736 until disease progression or adverse event.

Timeline

• Start date: 2014-09-15
• Primary completion: 2017-07-03
• Completion: 2017-07-03
• First posted: 2014-08-21
• Last updated: 2019-03-13

Locations

8 sites across 2 countries: United States, Australia