NCT03530397

A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors

A Phase 1, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability Pharmacokinetics Immunogenicity, and Antitumor Activity of MEDI5752 in Subjects With Advanced Solid Tumors.

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 401 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate MEDI5752 and carboplatin and pemetrexed or paclitaxel or nab-paclitaxel in adult subjects with advanced solid tumors, when administered as a single agent or combined with chemotherapy.

Detailed description

This is a phase 1, first-time-in-human, multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety and tolerability, and efficacy, pharmacokinetics and Immunogenicity of MEDI5752 and carboplatin and pemetrexed or paclitaxel or nab-paclitaxel in adult subjects with advanced solid tumors, when administered as a single agent or combined with chemotherapy.

Conditions

• Selected Advanced Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	MEDI5752	Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation.
DRUG	Pemetrexed	Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation
DRUG	Carboplatin	Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation
BIOLOGICAL	Pembrolizumab	Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation
DRUG	Paclitaxel or Nab-Paclitaxel	Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation

Timeline

• Start date: 2018-04-24
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2018-05-21
• Last updated: 2024-06-24

Locations

40 sites across 9 countries: United States, Australia, France, Italy, Netherlands, Portugal, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study