CompletedPhase 1 / Phase 2NCT03861793

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)

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.

Checked against the public recordLast updated Mar 5, 2024 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1 / Phase 2
U.S. locations48
SponsorMural Oncology, Inc
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Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Mural Oncology, Inc
Interventions being studied
Biological: ALKS 4230; Biological: Pembrolizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

Inclusion Criteria: * For Phase I the subject has histological or cytological evidence of a solid tumor. For Phase II the subject must have 1 of the specified adult solid tumor types: gastric, ovarian, lung, head and neck. * Subject must have at least one target lesion based on RECIST * Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 * Subjects must have adequate liver function * Subjects must have adequate kidney function * Subjects must be recovered from the effects of any prior chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy or surgery * Subjects who have received radiation therapy must wait at least 4 weeks after their last radiation treatment before enrollment into the study * Females of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and on Day 1 before the first dose is administered * Subject will agree to follow contraceptive requirements defined in the protocol * Additional criteria may apply Exclusion Criteria: * Subject is currently pregnant, planning to become pregnant, or breastfeeding * Subjects with an active infection or with a fever ≥ 38.5°C within 3 days of the first scheduled day of dosing for Cycle 1 * Subjects with active or symptomatic central nervous system metastases are excluded. Subjects with central nervous system metastases are eligible for the study if the metastases have been treated by surgery and/or radiation therapy, the subject is off corticosteroids for at least 2 weeks, and the subject is neurologically stable * Subjects with known hypersensitivity to any components of ALKS 4230 or to pembrolizumab or any of its excipients * Subjects who require pharmacologic doses of systemic corticosteroids are excluded; replacement doses, topical, ophthalmologic, and inhalational steroids are permitted * Subjects who developed autoimmune disorders while on prior immunotherapy, including pneumonitis, nephritis, and/or neuropathy * Subjects with any other concurrent uncontrolled illness, including mental illness or substance abuse, which may interfere with the ability of the subjects to cooperate and participate in the study * The subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B or C, or active tuberculosis, or has a known history of tuberculosis * Additional criteria may apply

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

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Study sites

U.S. locations

  • Mural Oncology Investigational SiteLos Angeles, California
  • Mural Oncology Investigational SiteLos Angeles, California
  • Mural Oncology Investigational SiteWashington D.C., District of Columbia
  • Mural Oncology Investigational SiteAtlanta, Georgia
  • Mural Oncology Investigational SiteChicago, Illinois
  • Mural Oncology Investigational SiteBethesda, Maryland
  • Mural Oncology Investigational SiteDetroit, Michigan
  • Mural Oncology Investigational SiteSaint Paul, Minnesota
  • Mural Oncology Investigational SiteMorristown, New Jersey
  • Mural Oncology Investigational SiteBuffalo, New York
  • Mural Oncology Investigational SiteHuntersville, North Carolina
  • Mural Oncology Investigational SiteCincinnati, Ohio

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 5, 2024. Always confirm current availability with the study team.

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