A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer

NCT05619172 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: SC105AURELIO-052022-001527-32
• Study Type: interventional
• Target: 16
• Locations: 3 countries
• Sites: 8

Brief Summary

The primary objective of the study is to estimate the antitumor efficacy of nanrilkefusp alfa (SOT101) in combination with cetuximab in RAS wild-type colorectal cancer.

Conditions

Colorectal Cancer

Keywords

SOT101; SO-C101; Cetuximab; Colorectal cancer; AURELIO-05; Nanrilkefusp alfa

Outcome Measures

Primary Outcomes (1)

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

  Objective response rate according to RECIST 1.1 was defined as the proportion of participants with complete response according to RECIST 1.1 or partial response according to RECIST 1.1 for target lesions and assessed by CT/MRI. Participants with missing data were considered non-responders.

  Day 1 up to approximately 1 year 2 months

Secondary Outcomes (30)

• Objective Response Rate According to RECIST for Immune-based Therapeutics (iRECIST)

  Day 1 up to approximately 1 year 5 months

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

  Day 1 up to approximately 1 year 5 months

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

  Day 1 up to approximately 1 year 5 months

• Best Overall Response According to RECIST 1.1: Number of Participants With Stable Disease

  Day 1 up to approximately 1 year 5 months

• Best Overall Response According to RECIST 1.1: Number of Participants With Progressive Disease

  Day 1 up to approximately 1 year 5 months

Study Arms (2)

Nanrilkefusp alfa 9 µg/kg and cetuximab

EXPERIMENTAL

Participants were treated with 9 µg/kg of nanrilkefusp alfa in combination with cetuximab. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.

Drug: Nanrilkefusp alfa; Drug: Cetuximab

Nanrilkefusp alfa 12 µg/kg and cetuximab

EXPERIMENTAL

Participants were treated with 12 µg/kg of nanrilkefusp alfa in combination with cetuximab. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.

Drug: Nanrilkefusp alfa; Drug: Cetuximab

Interventions

Nanrilkefusp alfa DRUG

Subcutaneous (SC) injection

Nanrilkefusp alfa 12 µg/kg and cetuximab; Nanrilkefusp alfa 9 µg/kg and cetuximab

Cetuximab DRUG

Intravenous (IV) infusion via peripheral or central venous line

Nanrilkefusp alfa 12 µg/kg and cetuximab; Nanrilkefusp alfa 9 µg/kg and cetuximab

Eligibility Criteria

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

You may qualify if:

• \*Type of patients\*
• ≥18 years of age on the day of signing informed consent
• Ability to understand and sign written informed consent to participate in the study
• Provides written informed consent for the study
• Life expectancy \>6 months
• \*Disease characteristics\*
• Histologically or cytologically confirmed advanced and/or metastatic colorectal cancer
• RAS wild type as confirmed by:
• locally performed US Food and Drug Administration (FDA)-approved test or an experienced local laboratory using validated test methods for the detection, based on tumor biopsy or
• locally performed ctDNA assessment including at least mutations in exon 2 (G12D, G12V, G12C, G12S, G12A, G12R, G13D) and determined by a laboratory using validated test methods
• samples must be taken within 3 months prior to first study administration
• Patients who are relapsed/refractory or intolerant to prior treatment with irinotecan- and oxaliplatin-containing chemotherapy
• Have at least one measurable lesion according to RECIST 1.1
• Eastern Cooperative Oncology Group (ECOG) performance score 0-2
• Must have recovered from all AEs due to previous therapies to grade ≤1 toxicity (excluding alopecia)

You may not qualify if:

• \*Prior/concomitant therapy\*
• Prior exposure to drugs that are agonists of IL-2 or IL-15
• Therapy with cetuximab within 3 months prior to ICF signature or patients who had progressive disease as best response to prior cetuximab-containing regimen
• Prior systemic anti-cancer therapies, including investigational agents before study entry (ICF signature):
• Less than 3 weeks or 5 half lives (whichever shorter) for anti-cancer treatments 3.2. Less than 4 weeks from major surgeries and not recovered adequately from the procedure and/or any complications from the surgery
• Has received more than 4 prior lines of systemic anticancer treatment
• Has received prior radiotherapy within 2 weeks of the start of study treatments. A 1-week radiation-free period is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system disease. Patients must have recovered from all radiation-related toxicities and not require corticosteroids.
• Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study treatments
• \*Prior/concurrent clinical study experience\*
• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 3 weeks or 5 half lives (whichever longer) before study entry (ICF signature). Patients who have entered the follow-up phase of an investigational study may participate as long as it has been 3 weeks or 5 half lives (whichever longer) after the last dose of the previous investigational agent.
• \*Medical conditions\*
• Patients with known BRAF mutations
• Clinically significant cardiac abnormalities including prior history of any of the following:
• Cardiomyopathy, with left ventricular ejection fraction lower than the lower limit of the institutional normal range at screening 9.2. Congestive heart failure of New York Heart Association grade ≥2 9.3. History of clinically significant (i.e., active) atherosclerotic cardiovascular disease, specifically myocardial infarction, unstable angina, cerebrovascular accident within 6 months prior to the first dose of study treatments, and any history of coronary heart disease and clinically significant peripheral and/or carotid artery disease 9.4. Prolongation of QTcF \>450 msec; history or family history of congenital long QT syndrome 9.5. Uncontrolled cardiac arrhythmia requiring medication
• Uncontrolled hypertension defined as systolic blood pressure \>160 mmHg, diastolic blood pressure \>110 mmHg. Patients with uncontrolled hypertension should be medically managed on a stable regimen to control hypertension prior to study entry (ICF signature).

Sponsors & Collaborators

• SOTIO Biotech AG: lead

Study Sites (8)

Grand Hopital de Charleroi - Hopital Notre Dame

Charleroi, 6000, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Institut Bergonié

Bordeaux, 33076, France

Location

Hopital Foch

Suresnes, 92150, France

Location

Vall d'Hebron Institut d'Oncologia (VHIO)

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

HM Universitario Sanchinarro

Madrid, 28050, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study SC105 (AURELIO-05) was a phase 2, open-label, single-arm, multicenter study of nanrilkefusp alfa in combination with cetuximab with an initial safety run-in with 3+3 safety cohorts. Two safety cohorts were implemented. The main cohort was not opened.

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 16, 2022
• Study Start: December 22, 2022
• Primary Completion: March 6, 2024
• Study Completion: June 5, 2024
• Last Updated: July 24, 2025
• Results First Posted: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); BE (2); ES (4)