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

NCT ID: NCT05256381

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-21
• Study Completion Date: 2024-11-29

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nanrilkefusp Alfa and Pembrolizumab

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.

Group Type: EXPERIMENTAL

Nanrilkefusp Alfa

Intervention Type: DRUG

Subcutaneous (SC) injection.

Pembrolizumab

Intervention Type: DRUG

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

Interventions

Nanrilkefusp Alfa

Subcutaneous (SC) injection.

Intervention Type: DRUG

Pembrolizumab

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

Intervention Type: DRUG

Other Intervention Names

SOT101; KEYTRUDA®

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

SOTIO Biotech AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Innovative Clinical Research Institute

Whittier, California, United States

University of Pittsburg Medical Center (UPMC) Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Institut Jules Bordet

Anderlecht, , Belgium

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Grand Hospital de Charleroi

Charleroi, , Belgium

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, , Belgium

Centre Hospitalier Universitaire de Liège

Liège, , Belgium

Masarykuv Onkologicky Ustav

Brno, , Czechia

Nemocnice Hořovice

Hořovice, , Czechia

Fakultní nemocnice Olomouc

Olomouc, , Czechia

Hôpital Ambroise-Paré

Boulogne-Billancourt, , France

Merchant Logo Institute Bergonié

Bourdeaux, , France

Centre de Lutte Contre le Cancer

Caen, , France

Centre Francois Baclesser

Caen, , France

Hospital del la Timone

Marseille, , France

Centre Hospitalier Universitaire de Nantes

Nantes, , France

Centre Antoine Lacassagne

Nice, , France

Hospital L'archet

Nice, , France

Hôpital Foch

Suresnes, , France

Institut Universitaire du Cancer de Toulouse Oncopole

Toulouse, , France

Institute Claudius Regaud

Toulouse, , France

Gustave Roussy

Villejuif, , France

High Technology Hospital MedCenter Ltd - Batumi

Batumi, , Georgia

Evex Hospitals- Kutaisi Referral

Kutaisi, , Georgia

LLC Todua Clinic

Tbilisi, , Georgia

Evex Hospitals - Caraps Medline

Tbilisi, , Georgia

New Vision University Hospital

Tbilisi, , Georgia

Tbilisi Institute of Medicine

Tbilisi, , Georgia

Jerarsi Clinic

Tbilisi, , Georgia

Consilium Medulla Multiprofile Clinic

Tbilisi, , Georgia

Evex Hospitals - Caucasus Medical Center

Tbilisi, , Georgia

Észak-Pesti Centrumkórház - Honvédkórház

Budapest, , Hungary

Petz Aladár Egyetemi Oktató Kórház - Győr

Győr, , Hungary

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

Brescia, , Italy

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

Meldola, , Italy

Instituto Nazionale Tumori IRCCS Fondazione G. Pascale

Napoli, , Italy

Ospedale Guglielmo da Saliceto

Piacenza, , Italy

Fondazione Policlinico Universitario Agostino Gemelli

Rome, , Italy

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

Siena, , Italy

Ospedale Civile di Sondrio

Sondrio, , Italy

Azienda Ospedaliera Universitaria Integrata Verona

Verona, , Italy

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Greater Poland Voivodeship, Poland

Pratia Poznań

Skorzewo, , Poland

MTZ Clinical Research powered by Pratia

Warsaw, , Poland

Hospital Teresa Herrera - Materno Infantil

A Coruña, , Spain

Hospital Germans Trias i Pujol

Badalona, , Spain

Hospital Universitari Vall d'Hebrón

Barcelona, , Spain

Institut Catala d'Oncologia

Barcelona, , Spain

Clinica Universidad de Navarra - Pamplona

Madrid, , Spain

Clínica Universidad de Navarra - Madrid

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario HM Sanchinarro

Madrid, , Spain

Hospital Universitario Puerta de Hierro - Majadahonda

Madrid, , Spain

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Countries

United States; Belgium; Czechia; France; Georgia; Hungary; Italy; Poland; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

KEYNOTE-D13

Identifier Type: OTHER

Identifier Source: secondary_id

AURELIO-04

Identifier Type: OTHER

Identifier Source: secondary_id

2021-005774-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-3475-D13

Identifier Type: OTHER

Identifier Source: secondary_id

SC104

Identifier Type: -

Identifier Source: org_study_id