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Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors

NCT04234113 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2026-03-27

Study results available
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Summary

A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of nanrilkefusp alfa as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors

Conditions

Interventions

DRUG

Nanrilkefusp alfa

A fusion protein which consists of the N-terminal sushi domain of human IL-15 receptor α covalently coupled via a linker of 20 amino acids to human IL-15

DRUG

Pembrolizumab

A humanized IgG4 monoclonal antibody with high specificity of binding to the PD-1 receptor

Sponsors & Collaborators

  • SOTIO Biotech a.s.

    collaborator INDUSTRY

  • SOTIO Biotech AG

    lead INDUSTRY

Principal Investigators

  • Stephane Champiat, Dr. · Institute Gustave Roussy, Villejuif, France

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-13
Primary Completion
2024-08-31
Completion
2024-11-27
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • France
  • Spain

Study Locations

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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 NCT04234113 on ClinicalTrials.gov