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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)

NCT03861793 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2024-03-05

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Mural Oncology, Inc

    lead INDUSTRY

Principal Investigators

  • Mural Oncology Medical Director · Mural Oncology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-26
Primary Completion
2023-03-01
Completion
2023-03-01
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Netherlands
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03861793 on ClinicalTrials.gov