Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors
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
Checked against the public recordLast updated Mar 27, 2026 · Source: ClinicalTrials.gov
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion 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 Exclusion 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.
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.