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

NCT05256381 | Terminated Phase 2 Results DMC FDA Drug

• 5 other identifiers: SC104KEYNOTE-D13AURELIO-042021-005774-25MK-3475-D13
• Study Type: interventional
• Target: 166
• Locations: 9 countries
• Sites: 54

Brief Summary

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

Conditions

Non-Small Cell Lung Cancer; Colorectal Cancer; Cutaneous Squamous Cell Carcinoma; Hepatocellular Carcinoma; Castration-resistant Prostate Cancer; Ovarian Cancer

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

Outcome Measures

Primary Outcomes (1)

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

  Day 1 up to approximately 2 years and 2 months

Secondary Outcomes (29)

• Number of Patients With a Treatment-emergent Adverse Event

  Day 1 up to approximately 2 years and 2 months

• Number of Patients With an Adverse Event of Special Interest

  Day 1 up to approximately 2 years and 2 months

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

  Day 1 up to approximately 2 years and 2 months

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

  Day 1 up to approximately 2 years and 2 months

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

  Day 1 up to approximately 2 years and 2 months

Study Arms (1)

Nanrilkefusp Alfa and Pembrolizumab

EXPERIMENTAL

Participants 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.

Drug: Nanrilkefusp Alfa; Drug: Pembrolizumab

Interventions

Nanrilkefusp Alfa DRUG

Subcutaneous (SC) injection.

Also known as: SOT101

Nanrilkefusp Alfa and Pembrolizumab

Pembrolizumab DRUG

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

Also known as: KEYTRUDA®

Nanrilkefusp Alfa and Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• SOTIO Biotech AG: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (54)

Innovative Clinical Research Institute

Whittier, California, 90603, United States

Location

University of Pittsburg Medical Center (UPMC) Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Institut Jules Bordet

Anderlecht, 1070, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Grand Hospital de Charleroi

Charleroi, 6000, Belgium

Location

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium

Location

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

Location

Masarykuv Onkologicky Ustav

Brno, 656 53, Czechia

Location

Nemocnice Hořovice

Hořovice, 268 31, Czechia

Location

Fakultní nemocnice Olomouc

Olomouc, 77900, Czechia

Location

Hôpital Ambroise-Paré

Boulogne-Billancourt, 92100, France

Location

Merchant Logo Institute Bergonié

Bourdeaux, 33000, France

Location

Centre de Lutte Contre le Cancer

Caen, 14076, France

Location

Centre Francois Baclesser

Caen, 14076, France

Location

Hospital del la Timone

Marseille, 13005, France

Location

Centre Hospitalier Universitaire de Nantes

Nantes, 44093, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hospital L'archet

Nice, 06202, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

Institut Universitaire du Cancer de Toulouse Oncopole

Toulouse, 31059, France

Location

Institute Claudius Regaud

Toulouse, 31059, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

High Technology Hospital MedCenter Ltd - Batumi

Batumi, 6000, Georgia

Location

Evex Hospitals- Kutaisi Referral

Kutaisi, 4600, Georgia

Location

LLC Todua Clinic

Tbilisi, 0112, Georgia

Location

Evex Hospitals - Caraps Medline

Tbilisi, 0159, Georgia

Location

New Vision University Hospital

Tbilisi, 0159, Georgia

Location

Tbilisi Institute of Medicine

Tbilisi, 0160, Georgia

Location

Jerarsi Clinic

Tbilisi, 0167, Georgia

Location

Consilium Medulla Multiprofile Clinic

Tbilisi, 0186, Georgia

Location

Evex Hospitals - Caucasus Medical Center

Tbilisi, 0186, Georgia

Location

Észak-Pesti Centrumkórház - Honvédkórház

Budapest, 1134, Hungary

Location

Petz Aladár Egyetemi Oktató Kórház - Győr

Győr, 9023, Hungary

Location

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

Brescia, 25123, Italy

Location

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

Meldola, 47014, Italy

Location

Instituto Nazionale Tumori IRCCS Fondazione G. Pascale

Napoli, 80131, Italy

Location

Ospedale Guglielmo da Saliceto

Piacenza, 29121, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli

Rome, 00168, Italy

Location

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

Siena, 53100, Italy

Location

Ospedale Civile di Sondrio

Sondrio, 23100, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona

Verona, 37134, Italy

Location

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Greater Poland Voivodeship, 60-780, Poland

Location

Pratia Poznań

Skorzewo, 60-185, Poland

Location

MTZ Clinical Research powered by Pratia

Warsaw, 02-172, Poland

Location

Hospital Teresa Herrera - Materno Infantil

A Coruña, 15006, Spain

Location

Hospital Germans Trias i Pujol

Badalona, 08916, Spain

Location

Hospital Universitari Vall d'Hebrón

Barcelona, 08035, Spain

Location

Institut Catala d'Oncologia

Barcelona, 08908, Spain

Location

Clinica Universidad de Navarra - Pamplona

Madrid, 28027, Spain

Location

Clínica Universidad de Navarra - Madrid

Madrid, 28027, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

Location

Hospital Universitario Puerta de Hierro - Majadahonda

Madrid, 28222, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Carcinoma, Hepatocellular; Ovarian Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Liver Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Results Point of Contact

• Title: Richard Kapsa
• Organization: SOTIO Biotech a.s.

kapsa@sotio.com

(+420) 2241 74448

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 25, 2022
• Study Start: June 21, 2022
• Primary Completion: August 31, 2024
• Study Completion: November 29, 2024
• Last Updated: November 17, 2025
• Results First Posted: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12); HU (2); CZ (3); IT (8); US (2); BE (5); GE (9); PL (3); ES (10)