NCT03946800

A Study of MEDI1191 in Sequential and Concurrent Combination With Durvalumab in Subjects With Advanced Solid Tumors

A Phase 1, Open-label, Dose-escalation and Expansion Study of MEDI1191 Administered Intratumorally as Monotherapy and in Combination With Durvalumab in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 101 Years
• Healthy volunteers: Not accepted

Summary

To evaluate MEDI1191 administered intratumorally in sequential and concurrent combination with intravenous durvalumab in patients with solid tumors.

Detailed description

This is a multicenter, open-label study to evaluate MEDI1191 delivered by intratumoral injection in sequential and concurrent combination with intravenous durvalumab to subjects with solid tumors. The study has a dose escalation design using mTPI-2 to evaluate a range of doses.

Conditions

• Solid Tumors
• Cancer

Interventions

Type	Name	Description
BIOLOGICAL	MEDI1191	Subjects will receive MEDI1191 (at least twice)
BIOLOGICAL	Durvalumab	Subject will receive durvalumab every 4 weeks

Timeline

• Start date: 2019-05-08
• Primary completion: 2023-08-24
• Completion: 2023-08-24
• First posted: 2019-05-13
• Last updated: 2024-10-02

Locations

11 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study