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TerminatedPhase 1NCT04234113
Official study title

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

Study 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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNanrilkefusp alfa and Pembrolizumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Mesothelioma · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 27, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?12 U.S. locations

Locations may change over time.

Who runs it?SOTIO Biotech AG

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
SOTIO Biotech AG
Interventions being studied
Drug: Nanrilkefusp alfa; Drug: Pembrolizumab
02
Explore related studies

How this study is categorized

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

Cancer type
Non-small cell lung cancer (NSCLC)→Mesothelioma→
Disease setting
Metastatic or stage IV→
Treatment approach
Immunotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Patients with selected histologically or cytologically confirmed advanced and/or metastatic solid tumors who are refractory to or intolerant of existing therapies known to provide clinical benefit for their condition.
  • ECOG performance score 0-1. Patients with ECOG performance score 2 to be discussed with the sponsor's medical monitor to be agreed for inclusion.
  • Estimated life expectancy of ≥3 months
  • Washout periods: 4 weeks for chemotherapy, 4 weeks or 5 half-lives (whichever shorter) for biologic agents including immuno-oncology therapy and 4 weeks from major surgeries, definitive radiotherapy and 2 weeks after palliative radiotherapy
  • At least one measurable lesion per iRECIST in a non-irradiated port. If in a previously irradiated port, must have demonstrated progression since best response to radiation therapy.
  • Have fully recovered from previous treatment to grade ≤1 toxicity (excluding alopecia) or have stable grade 2 neuropathy
  • Adequate organ system function
  • Negative serum pregnancy test, if woman of child-bearing potential (non-childbearing is defined as greater than one year postmenopausal or surgically sterilized).
  • Accessible tumor tissue available for fresh biopsy
Reasons someone may not be able to joinExclusion criteria
  • Untreated central nervous system metastases and/or leptomeningeal carcinomatosis
  • Known additional malignancy that is progressing and/or requires active treatment
  • Prior exposure to drugs that are agonists of IL-2- or IL-15-like but not limited to rhIL-15 (NCI), ALT-803 (ALTOR), NKTR-214 (Nektar)
  • History of and current interstitial lung disease or fibrosis and pneumonitis; patients with clinically significant or oxygen requiring chronic obstructive pulmonary disease or any chronic inflammatory disease (sarcoidosis etc.)
  • Has received a live vaccine within 30 days of planned start of study therapy
  • Absolute white blood cell count ≤2.0 ×10e9/L
  • Absolute neutrophil count ≤1.0 ×10e9/L
  • Platelet count ≤100×10e9/L
  • Pregnant or breastfeeding women
  • Any active autoimmune disease or a documented history of autoimmune disease, poorly controlled asthma, or history of syndrome that required systemic steroids (except the allowed doses) or immunosuppressive medications, except for patients with vitiligo or resolved childhood asthma/atopy
  • Specific co-morbidities
  • Parts B and B1:
  • Is hypersensitive to any of the ingredients of pembrolizumab drug product (KEYTRUDA®)
  • History of solid organ transplantation or hematopoietic stem cell transplantation

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

04
Study sites

U.S. locations

  • Yale Cancer CenterNew Haven, Connecticut
  • University of PittsburghPittsburgh, Pennsylvania
  • MD Anderson Cancer CenterHouston, Texas
  • Masarykův Onkologický Ústav Brno Klinika komplexní onkologické péčeBrno, Czechia
  • Centre Léon BérardLyon, France
  • Institut Gustave RoussyParis, France
  • Institut Claudius RegaudToulouse, France
  • Hôpitaux Universitaires de Marseille TimoneMarseille
  • Hopital Saint LouisParis
  • Institut de Cancerologie de L'OuestSaint-Herblain
  • Vall d'Hebron Institute of OncologyBarcelona, Spain
  • University Hospital SanchinarroMadrid

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 27, 2026. Always confirm current availability with the study team.

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