NCT05572684

A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants with Advanced Unresectable or Metastatic Solid Tumors

A Phase 1b/2, Open-Label, Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab for Participants with Advanced Unresectable And/or Metastatic Immune Checkpoint Inhibitor (ICI) Refractory Solid Tumors or ICI Naïve MSS/MSI-Low Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: NextCure, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, non-randomized, Phase 1b/2 study to determine the safety and tolerability of NC410 when combined with a standard dose of pembrolizumab. This study will also assess the clinical benefit of combination therapy in participants with advanced unresectable and/or metastatic ICI refractory solid tumors OR ICI naïve MSS/MSI-low solid tumors

Conditions

• Advanced or Metastatic Solid Tumors
• Microsatellite Instability Low
• Microsatellite Instability High
• Microsatellite Stable
• Ovarian Cancer
• Gastric Cancer
• Colo-rectal Cancer
• Esophageal Cancer
• Endometrial Cancer
• Head Neck Cancer
• Cervical Cancer
• Lung Cancer

Interventions

Type	Name	Description
DRUG	NC410	NC410 will be given intravenously (IV) every 2 weeks
DRUG	pembrolizumab	Pembrolizumab 400mg will be given IV every 6 weeks.

Timeline

• Start date: 2022-10-06
• Primary completion: 2025-07-01
• Completion: 2025-11-01
• First posted: 2022-10-10
• Last updated: 2024-12-16

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study