NCT03861793

A Dose Escalation and Cohort Expansion Study of Subcutaneously-Administered Cytokine ALKS 4230 (Nemvaleukin Alfa) as a Single Agent and in Combination With Anti-PD-1 Antibody (Pembrolizumab) in Subjects With Select Advanced or Metastatic Solid Tumors (ARTISTRY-2)

A Phase 1/2 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-2 (001)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Mural Oncology, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will characterize the safety and tolerability and identify the recommended Phase 2 dose (RP2D) of subcutaneous (SC) ALKS 4230 as monotherapy and in combination with pembrolizumab.

Detailed description

This study will evaluate ALKS 4230 administered SC as lead-in monotherapy and in combination with pembrolizumab in subjects with advanced solid tumors.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	ALKS 4230	SC injection administered in the back of the arm or the abdomen
BIOLOGICAL	Pembrolizumab	Administered as an intravenous (IV) infusion over 30 minutes

Timeline

• Start date: 2019-02-26
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2019-03-04
• Last updated: 2024-03-05

Locations

48 sites across 6 countries: United States, Canada, Netherlands, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study