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Non-Small Cell Lung CancerPhase 2NCT05256381

A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors

A Phase 2 study testing Nanrilkefusp Alfa and Pembrolizumab in people with Non-Small Cell Lung Cancer and Colorectal Cancer, run by SOTIO Biotech AG at 54 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The primary objective of the study is to estimate the antitumor efficacy of nanrilkefusp alfa in combination with pembrolizumab in selected tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nanrilkefusp Alfa and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
166 participants
Where
54 sitesin 9 countries
Study dates
21 Jun 2022to 29 Nov 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with the following histologically or cytologically confirmed solid tumor indications and line of treatment:
  • Non-small cell lung cancer (NSCLC).
  • Colorectal cancer.
  • Cutaneous squamous cell carcinoma (cSCC).
  • Advanced hepatocellular carcinoma (not applicable in France).
  • mCRPC.
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  • Ovarian cancer.
  • Have measurable disease per RECIST 1.1. mCRPC participants with no measurable disease and only widespread bone disease must have a CTC count of ≥5 cells per 7.5 mL of blood.
  • Availability of tumor tissue from a fresh biopsy at screening unless the biopsy cannot be obtained due to safety reasons or non-accessibility of the tumor site. If it is not possible to obtain a fresh biopsy, every effort should be taken to retrieve an archival biopsy. Archived, fixed tumor tissue may only be collected if taken preferentially after completion of the most recent systemic tumor therapy and within 12 months prior to the first dose of study treatment.
  • Eastern Cooperative Oncology Group (ECOG) score 0-1.
  • Have recovered from all AEs (except alopecia) due to previous therapies to grade ≤1 (excluding alopecia) or have stable grade 2 neuropathy.
  • Have adequate organ function as defined below:
  • Hematology:
  • Absolute neutrophil count ≥1500/μL.
  • Platelets ≥100 000/μL.
  • Hemoglobin ≥9.0 g/dL .
  • Renal function: Creatinine clearance as measured by glomerular filtration rate ≥30 mL/min using Cockcroft-Gault equation.
  • Hepatic function: Alanine transaminase (ALT)/aspartate transaminase (AST) ≤2.5× upper limit of normal (ULN) and total bilirubin ≤1.5×ULN or direct bilirubin ≤ ULN in participants without liver metastasis. In participants with liver metastasis, ALT/AST ≤5×ULN is allowed but total bilirubin must be ≤2×ULN.
  • Prothrombin time and activated partial thromboplastin time ≤1.5×ULN.
  • Participants must not have active hepatitis B or hepatitis C infection.
  • Adequate contraception must be applied in all women of childbearing potential (WOCBP) and in male participants.

Who cannot join

  • Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and was discontinued from that treatment due to a grade ≥3 AE.
  • Prior exposure to agonists of interleukin (IL)-2 or IL-15.
  • Prior systemic anti-cancer therapies, including investigational agents:
  • Less than 4 weeks for systemic chemotherapy and immuno-oncology therapies; and for tyrosine kinase inhibitors 4 weeks or 5 half-lives (whichever is shorter).
  • Less than 4 weeks from major surgeries and not recovered adequately.
  • Has received prior radiotherapy within 2 weeks of the start of study interventions or have had a history of radiation pneumonitis.
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  • NSCLC indication only: Received radiation therapy to the lung >30 Gy within 6 months.
  • Has received a live or live-attenuated vaccine within 30 days.
  • Clinically significant cardiac abnormalities including prior history of any of the following:
  • Cardiomyopathy, with left ventricular ejection fraction ≤ 50%.
  • Congestive heart failure of New York Heart Association grade ≥2.
  • History of clinically significant artery or coronary heart disease.
  • Prolongation of QTcF >450 msec .
  • Clinically significant cardiac arrythmia that cannot be controlled with adequate medication.
  • Uncontrolled hypertension defined as systolic blood pressure >160 mmHg, diastolic blood pressure >110 mmHg.
  • Prior allogeneic hematopoietic stem cell transplantation within the last 5 years.
  • Prior allogeneic tissue/solid organ transplant.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy.
  • History of or serology positive for human immunodeficiency virus (HIV).
  • Has a known additional malignancy that is progressing or has required active treatment within the past 5 years, except for basal cell carcinoma of the skin or carcinoma in situ that have undergone potentially curative therapy are not excluded.
  • Has known active central nervous system metastases and/or carcinomatous meningitis, unless stable.
  • Had severe hypersensitivity (grade ≥3) to pembrolizumab and/or any of its excipients.
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years.
  • History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease.
  • Has an active infection requiring systemic therapy.
  • Has any condition that might confound the results of the study or interfere with the participant's participation for the full duration of the study.

Trial locations and contacts

54 sites in 9 countries.

54 sites in 9 countries

France12 sites

  • Hôpital Ambroise-Paré

    Boulogne-Billancourt, 92100

  • Merchant Logo Institute Bergonié

    Bourdeaux, 33000

  • Centre de Lutte Contre le Cancer

    Caen, 14076

  • Centre Francois Baclesser

    Caen, 14076

  • Hospital del la Timone

    Marseille, 13005

  • Centre Hospitalier Universitaire de Nantes

    Nantes, 44093

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hospital L'archet

    Nice, 06202

  • Hôpital Foch

    Suresnes, 92150

  • Institut Universitaire du Cancer de Toulouse Oncopole

    Toulouse, 31059

  • Institute Claudius Regaud

    Toulouse, 31059

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

Spain10 sites

  • Hospital Teresa Herrera - Materno Infantil

    A Coruña, 15006

  • Hospital Germans Trias i Pujol

    Badalona, 08916

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 08035

  • Institut Catala d'Oncologia

    Barcelona, 08908

  • Clinica Universidad de Navarra - Pamplona

    Madrid, 28027

  • Clínica Universidad de Navarra - Madrid

    Madrid, 28027

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Madrid, 28222

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

Georgia9 sites

  • High Technology Hospital MedCenter Ltd - Batumi

    Batumi, 6000

  • Evex Hospitals- Kutaisi Referral

    Kutaisi, 4600

  • LLC Todua Clinic

    Tbilisi, 0112

  • Evex Hospitals - Caraps Medline

    Tbilisi, 0159

  • New Vision University Hospital

    Tbilisi, 0159

  • Tbilisi Institute of Medicine

    Tbilisi, 0160

  • Jerarsi Clinic

    Tbilisi, 0167

  • Consilium Medulla Multiprofile Clinic

    Tbilisi, 0186

  • Evex Hospitals - Caucasus Medical Center

    Tbilisi, 0186

Other trials in Georgia

Italy8 sites

  • Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia

    Brescia, 25123

  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST

    Meldola, 47014

  • Instituto Nazionale Tumori IRCCS Fondazione G. Pascale

    Naples, 80131

  • Ospedale Guglielmo da Saliceto

    Piacenza, 29121

  • Fondazione Policlinico Universitario Agostino Gemelli

    Rome, 00168

  • Azienda Ospedaliera Universitaria Senese - L'ospedale Santa Maria alle Scotte

    Siena, 53100

  • Ospedale Civile di Sondrio

    Sondrio, 23100

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37134

Other trials in Italy

Belgium5 sites

  • Institut Jules Bordet

    Anderlecht, 1070

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Grand Hospital de Charleroi

    Charleroi, 6000

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000

Other trials in Belgium

Czechia3 sites

  • Masarykuv Onkologicky Ustav

    Brno, 656 53

  • Nemocnice Hořovice

    Hořovice, 268 31

  • Fakultní nemocnice Olomouc

    Olomouc, 77900

Other trials in Czechia

Poland3 sites

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, Greater Poland Voivodeship, 60-780

  • Pratia Poznań

    Skorzewo, 60-185

  • MTZ Clinical Research powered by Pratia

    Warsaw, 02-172

Other trials in Poland

United States2 sites

  • University of Pittsburg Medical Center (UPMC) Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Innovative Clinical Research Institute

    Whittier, California, 90603

Other trials in United States

Hungary2 sites

  • Észak-Pesti Centrumkórház - Honvédkórház

    Budapest, 1134

  • Petz Aladár Egyetemi Oktató Kórház - Győr

    Győr, 9023

Other trials in Hungary

About this study

Official title: A Phase 2, Open-label, Single-arm, Multicenter Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced/Refractory Solid Tumors

The primary objective of the study is to estimate the antitumor efficacy of nanrilkefusp alfa in combination with pembrolizumab in selected tumors.

Being tested
Nanrilkefusp Alfa, Pembrolizumab
Keywords
SOT101, SO-C101, Pembrolizumab, Non-Small Cell Lung Cancer, Colorectal Cancer, Cutaneous Squamous Cell Carcinoma, Advanced Hepatocellular Carcinoma, Metastatic Castration-resistant Prostate Cancer, Ovarian Cancer, KEYNOTE-D13, AURELIO-04, Nanrilkefusp Alfa
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Carcinoma, Hepatocellular, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nanrilkefusp AlfaDrug

    Also called SOT101

    Subcutaneous (SC) injection.

  • PembrolizumabDrug

    Also called KEYTRUDA®

    Intravenous (IV) infusion via peripheral or central venous line.

Study groups in NCT05256381
Study groupRoleWhat they receive
Nanrilkefusp Alfa and PembrolizumabExperimentalParticipants will be treated with 12 μg/kg of nanrilkefusp alfa on Day 1, Day 2, Day 8, and Day 9 of each 3-week cycle in combination with 200 mg pembrolizumab on Day 1 of each 3-week cycle.
Receives: Drug: Nanrilkefusp Alfa; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Patients With Objective Response Rate According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)

    Measured: Day 1 up to approximately 2 years and 2 months

Secondary outcomes (29)

  1. Number of Patients With a Treatment-emergent Adverse Event

    Measured: Day 1 up to approximately 2 years and 2 months

  2. Number of Patients With an Adverse Event of Special Interest

    Measured: Day 1 up to approximately 2 years and 2 months

  3. Percentage of Patients With Objective Response Rate According to RECIST for Immune-based Therapeutics (iRECIST)

    Measured: Day 1 up to approximately 2 years and 2 months

  4. Number of Patients With Best Overall Response According to RECIST 1.1: Complete Response

    Measured: Day 1 up to approximately 2 years and 2 months

  5. Number of Patients With Best Overall Response According to RECIST 1.1: Partial Response

    Measured: Day 1 up to approximately 2 years and 2 months

  6. Number of Patients With Best Overall Response According to RECIST 1.1: Stable Disease

    Measured: Day 1 up to approximately 2 years and 2 months

  7. Number of Patients With Best Overall Response According to RECIST 1.1: Progressive Disease

    Measured: Day 1 up to approximately 2 years and 2 months

  8. Number of Patients With Best Overall Response According to iRECIST: Complete Response

    Measured: Day 1 up to approximately 2 years and 2 months

  9. Number of Patients With Best Overall Response According to iRECIST: Partial Response

    Measured: Day 1 up to approximately 2 years and 2 months

  10. Number of Patients With Best Overall Response According to iRECIST: Stable Disease

    Measured: Day 1 up to approximately 2 years and 2 months

  11. Number of Patients With Best Overall Response According to iRECIST: Unconfirmed Progressive Disease

    Measured: Day 1 up to approximately 2 years and 2 months

  12. Number of Patients With Best Overall Response According to iRECIST: Confirmed Progressive Disease

    Measured: Day 1 up to approximately 2 years and 2 months

  13. Duration of Response According to RECIST 1.1

    Measured: Day 1 up to approximately 2 years and 2 months

  14. Duration of Response According to iRECIST

    Measured: Day 1 up to approximately 2 years and 2 months

  15. Percentage of Patients With Clinical Benefit Rate According to RECIST 1.1

    Measured: Day 1 up to approximately 2 years and 2 months

  16. Percentage of Patients With Clinical Benefit Rate According to iRECIST

    Measured: Day 1 up to approximately 2 years and 2 months

  17. Progression-free Survival According to RECIST 1.1

    Measured: Day 1 up to approximately 2 years and 2 months

  18. Progression-free Survival According to iRECIST

    Measured: Day 1 up to approximately 2 years and 2 months

  19. Time to Response According to RECIST 1.1

    Measured: Day 1 up to approximately 2 years and 2 months

  20. Time to Response According to iRECIST

    Measured: Day 1 up to approximately 2 years and 2 months

  21. Duration of Response According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1

    Measured: Day 1 up to approximately 2 years and 2 months

  22. Percentage of Patients With Clinical Benefit Rate According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1

    Measured: Day 1 up to approximately 2 years and 2 months

  23. Progression-free Survival According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1

    Measured: Day 1 up to approximately 2 years and 2 months

  24. Percentage of Patients With Circulating Tumor Cell Count Conversion as Assessed According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1

    Measured: Day 1 up to approximately 2 years

  25. Percentage of Patients With Confirmed Prostate-specific Antigen Decline of ≥50% as Assessed According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1

    Measured: Day 1 up to approximately 2 years

  26. Time to Confirmed Prostate-specific Antigen Progression as Assessed According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1

    Measured: Day 1 up to approximately 2 years

  27. Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 30 (+/-5) Minutes After Nanrilkefusp Alfa Administration

    Measured: Cycle 1 Day 1, 30 (+/-5) minutes after nanrilkefusp alfa administration

  28. Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 2 Hours (+/-15 Minutes) After Nanrilkefusp Alfa Administration

    Measured: Cycle 1 Day 1, 2 hours (+/-15 minutes) after nanrilkefusp alfa administration

  29. Number of Patients With Anti-drug Antibodies, Cycle 4 Day 1

    Measured: Cycle 4 Day 1, approximately 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2022
  2. Study start21 Jun 2022
  3. Primary completion31 Aug 2024
  4. Study completion29 Nov 2024

Why it stopped: Due to lack of expected efficacy shown at the time of the interim analysis

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05256381
Sponsor's protocol ID
SC104
Other IDs
KEYNOTE-D13, AURELIO-04, 2021-005774-25, MK-3475-D13
Status last verified
Nov 2025
First submitted
8 Feb 2022
Last updated
17 Nov 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nanrilkefusp Alfa and Pembrolizumab in people with Non-Small Cell Lung Cancer and Colorectal Cancer, run by SOTIO Biotech AG at 54 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in France, Spain, Georgia, Italy, Belgium and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With Objective Response Rate According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) (time frame: Day 1 up to approximately 2 years and 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05256381.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.

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