Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors
NCT ID: NCT04234113
Last Updated: 2025-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
115 participants
INTERVENTIONAL
2019-06-13
2024-11-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Experimental: Part A (nanrilkefusp alfa monotherapy)
Drug: Nanrilkefusp alfa
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
Experimental: Part B (nanrilkefusp alfa combined with pembrolizumab)
Drug: Nanrilkefusp alfa Drug: Pembrolizumab
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
Pembrolizumab
A humanized IgG4 monoclonal antibody with high specificity of binding to the PD-1 receptor
Experimental: Part A1 (nanrilkefusp alfa divided dosing, monotherapy)
Drug: Nanrilkefusp alfa, twice a day as 2 divided doses (50%:50%)
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
Experimental: Part B1 (nanrilkefusp alfa divided dosing, combined with pembrolizumab)
Drug: Nanrilkefusp alfa, twice a day as 2 divided doses (50%:50%) Drug: Pembrolizumab
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
Pembrolizumab
A humanized IgG4 monoclonal antibody with high specificity of binding to the PD-1 receptor
Experimental: Part D (nanrilkefusp alfa monotherapy, expansion at the RP2D identified in Part A)
Drug: Nanrilkefusp alfa Indications: Relapsed/refractory advanced/metastatic renal cell carcinoma, relapsed/refractory advanced/metastatic skin squamous-cell carcinoma, relapsed/refractory advanced/metastatic melanoma
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
Part D1 (nanrilkefusp alfa divided dosing, monotherapy, expansion at the RP2D identified in Part A1)
Drug: Nanrilkefusp alfa, twice a day as 2 divided doses (50%:50%) Indications: Relapsed/refractory advanced/metastatic renal cell carcinoma, relapsed/refractory advanced/metastatic skin squamous-cell carcinoma, relapsed/refractory advanced/metastatic melanoma
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
Interventions
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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
Pembrolizumab
A humanized IgG4 monoclonal antibody with high specificity of binding to the PD-1 receptor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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SOTIO Biotech a.s.
INDUSTRY
SOTIO Biotech AG
INDUSTRY
Responsible Party
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Principal Investigators
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Stephane Champiat, Dr.
Role: PRINCIPAL_INVESTIGATOR
Institute Gustave Roussy, Villejuif, France
Locations
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Yale Cancer Center
New Haven, Connecticut, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Masarykův Onkologický Ústav Brno Klinika komplexní onkologické péče
Brno, , Czechia
Centre Léon Bérard
Lyon, , France
Hôpitaux Universitaires de Marseille Timone
Marseille, , France
Hopital Saint Louis
Paris, , France
Institut Gustave Roussy
Paris, , France
Institut de Cancerologie de L'Ouest
Saint-Herblain, , France
Institut Claudius Regaud
Toulouse, , France
Vall d'Hebron Institute of Oncology
Barcelona, , Spain
University Hospital Sanchinarro
Madrid, , Spain
Countries
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Other Identifiers
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AURELIO-03
Identifier Type: OTHER
Identifier Source: secondary_id
2018-004334-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SC103
Identifier Type: -
Identifier Source: org_study_id
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