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Promising cancer combo trial halted early

NCT ID NCT05256381

Disease control Sponsor: SOTIO Biotech AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called SOT101 (nanrilkefusp alfa) combined with pembrolizumab in 166 people with advanced solid tumors like lung, colon, and ovarian cancer. The goal was to see if the combo could shrink tumors. The trial was stopped early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

166 people

The number who actually took part.

Started

Jun 2022

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants with the following histologically or cytologically confirmed solid tumor indications and line of treatment: 1. Non-small cell lung cancer (NSCLC). 2. Colorectal cancer. 3. Cutaneous squamous cell carcinoma (cSCC). 4. Advanced hepatocellular carcinoma (not applicable in France). 5. mCRPC. 6. 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: 1. Hematology: 1. Absolute neutrophil count ≥1500/μL. 2. Platelets ≥100 000/μL. 3. Hemoglobin ≥9.0 g/dL . 2. Renal function: Creatinine clearance as measured by glomerular filtration rate ≥30 mL/min using Cockcroft-Gault equation. 3. 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. 4. 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. Exclusion Criteria: * 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: 1. 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). 2. 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. * 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: 1. Cardiomyopathy, with left ventricular ejection fraction ≤ 50%. 2. Congestive heart failure of New York Heart Association grade ≥2. 3. History of clinically significant artery or coronary heart disease. 4. Prolongation of QTcF \>450 msec . 5. 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.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma colorectal cancer colorectal neoplasm hepatocellular carcinoma metastatic prostate carcinoma non-small cell lung carcinoma ovarian cancer skin squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Castration-resistant prostate cancer Colorectal cancer Cutaneous squamous cell carcinoma Hepatocellular carcinoma Non-small cell lung cancer Ovarian cancer

Contacts and locations

Locations

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37134, Italy

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

    Siena, 53100, Italy

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

    Brescia, 25123, Italy

  • Centre Antoine Lacassagne

    Nice, 06189, France

  • Centre Francois Baclesser

    Caen, 14076, France

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000, Belgium

  • Centre Hospitalier Universitaire de Nantes

    Nantes, 44093, France

  • Centre de Lutte Contre le Cancer

    Caen, 14076, France

  • Clinica Universidad de Navarra - Pamplona

    Madrid, 28027, Spain

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Clínica Universidad de Navarra - Madrid

    Madrid, 28027, Spain

  • Consilium Medulla Multiprofile Clinic

    Tbilisi, 0186, Georgia

  • Evex Hospitals - Caraps Medline

    Tbilisi, 0159, Georgia

  • Evex Hospitals - Caucasus Medical Center

    Tbilisi, 0186, Georgia

  • Evex Hospitals- Kutaisi Referral

    Kutaisi, 4600, Georgia

  • Fakultní nemocnice Olomouc

    Olomouc, 77900, Czechia

  • Fondazione Policlinico Universitario Agostino Gemelli

    Rome, 00168, Italy

  • Grand Hospital de Charleroi

    Charleroi, 6000, Belgium

  • Gustave Roussy

    Villejuif, 94805, France

  • High Technology Hospital MedCenter Ltd - Batumi

    Batumi, 6000, Georgia

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Germans Trias i Pujol

    Badalona, 08916, Spain

  • Hospital L'archet

    Nice, 06202, France

  • Hospital Teresa Herrera - Materno Infantil

    A Coruña, 15006, Spain

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050, Spain

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Madrid, 28222, Spain

  • Hospital del la Timone

    Marseille, 13005, France

  • Hôpital Ambroise-Paré

    Boulogne-Billancourt, 92100, France

  • Hôpital Foch

    Suresnes, 92150, France

  • Innovative Clinical Research Institute

    Whittier, California, 90603, United States

  • Institut Catala d'Oncologia

    Barcelona, 08908, Spain

  • Institut Jules Bordet

    Anderlecht, 1070, Belgium

  • Institut Universitaire du Cancer de Toulouse Oncopole

    Toulouse, 31059, France

  • Institute Claudius Regaud

    Toulouse, 31059, France

  • Instituto Nazionale Tumori IRCCS Fondazione G. Pascale

    Naples, 80131, Italy

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

    Meldola, 47014, Italy

  • Jerarsi Clinic

    Tbilisi, 0167, Georgia

  • LLC Todua Clinic

    Tbilisi, 0112, Georgia

  • MTZ Clinical Research powered by Pratia

    Warsaw, 02-172, Poland

  • Masarykuv Onkologicky Ustav

    Brno, 656 53, Czechia

  • Merchant Logo Institute Bergonié

    Bourdeaux, 33000, France

  • Nemocnice Hořovice

    Hořovice, 268 31, Czechia

  • New Vision University Hospital

    Tbilisi, 0159, Georgia

  • Ospedale Civile di Sondrio

    Sondrio, 23100, Italy

  • Ospedale Guglielmo da Saliceto

    Piacenza, 29121, Italy

  • Petz Aladár Egyetemi Oktató Kórház - Győr

    Győr, 9023, Hungary

  • Pratia Poznań

    Skorzewo, 60-185, Poland

  • Tbilisi Institute of Medicine

    Tbilisi, 0160, Georgia

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000, Belgium

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

    Pittsburgh, Pennsylvania, 15232, United States

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, Greater Poland Voivodeship, 60-780, Poland

  • Észak-Pesti Centrumkórház - Honvédkórház

    Budapest, 1134, Hungary

More trials for these conditions

Other studies related to the condition(s) this trial covers.