NCT04261075

IPH5201 as Monotherapy or in Combination With Durvalumab +/- Oleclumab in Subjects With Advanced Solid Tumors.

A Phase 1, First-in-Human, Multicenter, Open-label, Dose-escalation Study of IPH5201 as Monotherapy or in Combination With Durvalumab ± Oleclumab in Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 101 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and tolerability and to determine the dose of IPH5201 that can be used as monotherapy or in combination with durvalumab +/- oleclumab in subjects with advanced solid tumors.

Detailed description

Study D6770C00001 is a Phase 1, first-in-human, multicenter, open-label, dose-escalation study to evaluate the safety, tolerability, antitumor activity, pharmacokinetics, and immunogenicity of IPH5201 in adult subjects with advanced solid tumors, when administered as monotherapy or in combination with durvalumab ± oleclumab.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	IPH5201	Ascending dose levels of IPH5201 every 3 weeks (Q3W) for a maximum of 2 years
BIOLOGICAL	durvalumab	Durvalumab Q3W for a maximum of 2 years
BIOLOGICAL	oleclumab	Oleclumab Q3W for a maximum of 2 years

Timeline

• Start date: 2020-03-03
• Primary completion: 2022-06-16
• Completion: 2022-06-16
• First posted: 2020-02-07
• Last updated: 2022-08-15

Locations

8 sites across 4 countries: United States, France, Spain, Switzerland

Regulatory

• FDA-regulated drug study