Colorectal CancerPhase 2NCT05619172
A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer
A Phase 2 study testing Nanrilkefusp alfa and Cetuximab in people with Colorectal Cancer, run by SOTIO Biotech AG at 8 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Nanrilkefusp alfa and Cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 22 Dec 2022to 5 Jun 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
- 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
Show all 29Show fewer
- 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)
- Organ function: Have adequate organ function as defined below. Specimens must be collected within 7 days prior to the start of study treatment.
- Hematology:
- 11.1. Absolute neutrophil count ≥1,500/µL 11.2. Platelets ≥100,000/µL 11.3. Hemoglobin ≥9.0 g/dL (criteria must be met without packed red blood cell transfusion within the prior 2 weeks; patients can be on stable dose of erythropoietin [≥3 months])
- Renal function: Creatinine clearance rate ≥50 mL/min as calculated using Cockcroft-Gault equation
- Hepatic function: ALT/AST ≤2.5× upper limit of normal (ULN) and total bilirubin ≤2×ULN in patients without liver metastasis (benign hereditary hyperbilirubinemias, e.g., Gilbert's syndrome, are permitted if total bilirubin <3 mg/dL). In patients 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
- Hepatitis
- A locally performed hepatitis B (HBV) test is required during screening. Patients who are HBV surface antigen positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks and have undetectable HBV viral load before study entry (ICF signature). Patients should remain on anti-viral therapy throughout study treatment and follow local guidelines for HBV anti-viral therapy post completion of study treatments.
- A locally performed hepatitis C (HCV) test is required during screening. Patients with history of HCV infection are eligible if HCV viral load is undetectable at screening. Patients must have completed anti-viral therapy at least 4 weeks before study entry (ICF signature).
- Special requirements for contraception
- A female patient is eligible to participate if she is not pregnant, not breastfeeding, and one of the following conditions applies:
- 17.1. Not a woman of childbearing potential (WOCBP). A WOCBP is defined as fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single follicle stimulating hormone measurement is insufficient.
- 17.2. A WOCBP who agrees to use a highly effective contraceptive method during the treatment period and for at least 60 days after the last dose of cetuximab or at least 30 days after last dose of nanrilkefusp alfa, whichever is later. A WOCBP can only be included after a negative serum pregnancy test at screening within 7 days before day 1 of cycle 1.
- Male patients must agree to use a condom during the treatment period and for at least 60 days after the last dose of cetuximab or at least 30 days after last dose of nanrilkefusp alfa, whichever is later.
Who cannot join
- 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):
- 3.1. 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
Show all 24Show fewer
- 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:
- 9.1. 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).
- Has a clinical diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatments. Systemic steroid pretreatment prior to cetuximab infusion according to local guidelines is permitted.
- History of or serology positive for HIV. A locally performed HIV test is required during screening.
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Patients with basal cell carcinoma of the skin or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are eligible.
- Has known active central nervous system metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks confirmed during screening.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- Has an active infection requiring systemic therapy
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator
- Has a known psychiatric or substance abuse disorder that would interfere with the patient's ability to cooperate with the requirements of the study
- History of hypersensitivity to any component of cetuximab or to compounds of similar biological or chemical composition of nanrilkefusp alfa and/or the excipients contained in the study drug formulations
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Spain4 sites
Vall d'Hebron Institut d'Oncologia (VHIO)
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitario Ramón y Cajal
Madrid, 28034
HM Universitario Sanchinarro
Madrid, 28050
Belgium2 sites
Grand Hopital de Charleroi - Hopital Notre Dame
Charleroi, 6000
Universitair Ziekenhuis Gent
Ghent, 9000
About this study
Official title: A Phase 2, Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of SOT101 in Combination With Cetuximab in Patients With RAS Wild-type Colorectal Cancer
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
- Being tested
- Nanrilkefusp alfa, Cetuximab
- Keywords
- SOT101, SO-C101, Cetuximab, Colorectal cancer, AURELIO-05, Nanrilkefusp alfa
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanrilkefusp alfaDrug
Subcutaneous (SC) injection
CetuximabDrug
Intravenous (IV) infusion via peripheral or central venous line
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Nanrilkefusp alfa; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 up to approximately 1 year 2 months
Secondary outcomes (30)
Objective Response Rate According to RECIST for Immune-based Therapeutics (iRECIST)
Objective response rate according to iRECIST was defined as the proportion of participants with complete response according to iRECIST or partial response according to iRECIST for target lesions and assessed by CT/MRI. Participants with missing data were considered non-responders.
Measured: Day 1 up to approximately 1 year 5 months
Best Overall Response According to RECIST 1.1: Number of Participants With Complete Response
The best overall response according to RECIST 1.1 was defined as the best response from the start of study treatment until the first documented disease progression, death, or start of new anti-cancer therapy for target lesions and assessed by CT/MRI.
Measured: Day 1 up to approximately 1 year 5 months
Best Overall Response According to RECIST 1.1: Number of Participants With Partial Response
The best overall response according to RECIST 1.1 was defined as the best response from the start of study treatment until the first documented disease progression, death, or start of new anti-cancer therapy for target lesions and assessed by CT/MRI.
Measured: Day 1 up to approximately 1 year 5 months
Best Overall Response According to RECIST 1.1: Number of Participants With Stable Disease
The best overall response according to RECIST 1.1 was defined as the best response from the start of study treatment until the first documented disease progression, death, or start of new anti-cancer therapy for target lesions and assessed by CT/MRI. Stable disease according to RECIST 1.1 had to last at least 6 weeks from the start of study treatment. If not, at least 1 follow-up scan was required to declare stable disease.
Measured: Day 1 up to approximately 1 year 5 months
Best Overall Response According to RECIST 1.1: Number of Participants With Progressive Disease
The best overall response according to RECIST 1.1 was defined as the best response from the start of study treatment until the first documented disease progression, death, or start of new anti-cancer therapy for target lesions and assessed by CT/MRI.
Measured: Day 1 up to approximately 1 year 5 months
Best Overall Response According to iRECIST: Number of Participants With Complete Response
The best overall response according to iRECIST was defined as the best response from the start of study treatment until the first documented disease progression, death, or start of new anti-cancer therapy for target lesions and assessed by CT/MRI.
Measured: Day 1 up to approximately 1 year 5 months
Best Overall Response According to iRECIST: Number of Participants With Partial Response
The best overall response according to iRECIST was defined as the best response from the start of study treatment until the first documented disease progression, death, or start of new anti-cancer therapy for target lesions and assessed by CT/MRI.
Measured: Day 1 up to approximately 1 year 5 months
Best Overall Response According to iRECIST: Number of Participants With Stable Disease
The best overall response according to iRECIST was defined as the best response from the start of study treatment until the first documented disease progression, death, or start of new anti-cancer therapy for target lesions and assessed by CT/MRI. Stable disease according to iRECIST had to last at least 6 weeks from the start of study treatment. If not, at least 1 follow-up scan was required to declare stable disease.
Measured: Day 1 up to approximately 1 year 5 months
Best Overall Response According to iRECIST: Number of Participants With Unconfirmed Progressive Disease
The best overall response according to iRECIST was defined as the best response from the start of study treatment until the first documented disease progression, death, or start of new anti-cancer therapy for target lesions and assessed by CT/MRI.
Measured: Day 1 up to approximately 1 year 5 months
Best Overall Response According to iRECIST: Number of Participants With Confirmed Progressive Disease
The best overall response according to iRECIST was defined as the best response from the start of study treatment until the first documented disease progression, death, or start of new anti-cancer therapy for target lesions and assessed by CT/MRI.
Measured: Day 1 up to approximately 1 year 5 months
Duration of Response According to RECIST 1.1
Duration of response according to RECIST 1.1 was defined as time to disease progression for participants with partial response or complete response according to RECIST 1.1.
Measured: Day 1 up to approximately 1 year 5 months
Duration of Response According to iRECIST
Duration of response according to iRECIST was defined as time to disease progression for participants with partial response or complete response according to iRECIST.
Measured: Day 1 up to approximately 1 year 5 months
Clinical Benefit Rate According to RECIST 1.1
Clinical benefit rate according to RECIST 1.1 was defined as the number of partial responses, complete responses, and stable disease according to RECIST 1.1. Stable disease had to last at least 6 weeks from the start of study treatment. If not, at least 1 follow-up scan was required to declare stable disease. Participants with missing data were considered non-responders.
Measured: Day 1 up to approximately 1 year 5 months
Clinical Benefit Rate According to iRECIST
Clinical benefit rate according to iRECIST was defined as the number of partial responses, complete responses, and stable disease according to iRECIST. Stable disease had to last at least 6 weeks from the start of study treatment. If not, at least 1 follow-up scan was required to declare stable disease. Participants with missing data were considered non-responders.
Measured: Day 1 up to approximately 1 year 5 months
Progression-free Survival According to RECIST 1.1
Progression-free survival according to RECIST 1.1 was defined as the time from the first day of study treatment to the first date of radiological disease progression according to RECIST 1.1 or death.
Measured: Day 1 up to approximately 1 year 5 months
Progression-free Survival According to iRECIST
Progression-free survival according to iRECIST was defined as the time from the first day of study treatment to the first date of radiological disease progression according to iRECIST or death.
Measured: Day 1 up to approximately 1 year 5 months
Time to Response According to RECIST 1.1
Time to response according to RECIST 1.1 was defined as the time from the first day of study treatment to the first date of partial response or complete response according to RECIST 1.1. Participants with missing data were censored at the last assessment date, date of death, or date of eligibility (for incomplete or missing baseline tumor assessments), whichever occurred last.
Measured: Day 1 up to approximately 1 year 5 months
Time to Response According to iRECIST
Time to response according to iRECIST was defined as the time from the first day of study treatment to the first date of partial response or complete response according to iRECIST. Participants with missing data were censored at the last assessment date, date of death, or date of eligibility (for incomplete or missing baseline tumor assessments), whichever occurred last.
Measured: Day 1 up to approximately 1 year 5 months
Time to Progression According to RECIST 1.1
Time to progression according to RECIST 1.1 was defined as the time from the first day of study treatment to the first date of radiological disease progression according to RECIST 1.1.
Measured: Day 1 up to approximately 1 year 5 months
Time to Progression According to iRECIST
Time to progression according to iRECIST was defined as the time from the first day of study treatment to the first date of radiological disease progression according to iRECIST.
Measured: Day 1 up to approximately 1 year 5 months
Number of Participants With Treatment-emergent Adverse Events
A treatment-emergent adverse event is defined as an adverse event that started or worsened at or after the start of study treatment.
Measured: Day 1 up to approximately 1 year 5 months
Number of Participants With Clinical Laboratory Test Abnormalities (Coagulation, Hematology, Clinical Chemistry and Urinalysis)
The following laboratory parameters will be assessed:
Coagulation: prothrombin time, activated partial thromboplastin time, international normalized ratio, D-dimer, and fibrinogen
Hematology: hemoglobin, glycated hemoglobin at screening, hematocrit, red blood cell count, reticulocytes, white blood cell count (with full differentiation), absolute lymphocyte count, and platelet count
Clinical chemistry: Na, K, Cl, phosphate, Mg, Ca, albumin, total protein, ALT, AST, bilirubin (direct, total), alkaline phosphatase, lactate dehydrogenase, creatinine clearance calculated by the Cockcroft-Gault formula, creatinine, glucose (preferably fasting), urea or blood urea nitrogen, cholesterol, triglyceride, C-reactive protein, uric acid, amylase, and lipase
Urinalysis: pH, glucose, protein, bilirubin, urobilinogen. Microscopic examination (mandated only if clinically indicated): red blood cell count, white blood cell count, epithelial cells, bacteria
Measured: Day 1 up to approximately 1 year 5 months
Number of Participants With Vital Signs Abnormalities
The following vital signs parameters will be assessed:
Blood pressure (systolic and diastolic, after ≥5 minutes of rest), body temperature, and heart rate
Measured: Day 1 up to approximately 1 year 5 months
Number of Participants With Electrocardiography Abnormalities
Standard 12-lead electrocardiography was evaluated locally.
Measured: Day 1 up to approximately 1 year 5 months
Number of Participants With Dose-limiting Toxicities (DLTs)
The following adverse events as per NCI CTCAE version 5.0 were considered dose-limiting toxicities:
- All grade 5 events not clearly related to disease progression or any other causes
- Any grade 3 or higher non-hematologic toxicity regardless of duration; exceptions:
- Grade 3 nausea, vomiting, or diarrhea that could be controlled within 72 hours
- Grade 3 fatigue lasting less than 5 days
- Grade 3 or higher correctable electrolyte abnormalities lasting less than 72 hours and not associated with clinical complications
- Grade 3 or higher serum amylase or lipase not associated with clinical manifestations of pancreatitis
- Grade 3 AST or ALT increase or grade 3 blood bilirubin increase lasting 5 days or less
- Hy's law cases
- Hematologic DLTs:
- Grade 4 decreased neutrophil count or decreased platelet count lasting more than 7 days
- Febrile neutropenia
- Grade 3 or higher decreased platelet count with bleeding
Measured: Through Cycle 1 (21 days)
Characterization of Area Under the Curve of Nanrilkefusp Alfa
At 9 µg/kg nanrilkefusp alfa on Day 1 of Cycle 1
Measured: Day 1 of Cycle 1
Characterization of Maximum Concentration of Nanrilkefusp Alfa on Day 1 of Cycle 1
At 9 µg/kg nanrilkefusp alfa
Measured: Day 1 of Cycle 1
Characterization of Time to Maximum Concentration of Nanrilkefusp Alfa on Day 1 of Cycle 1
At 9 µg/kg nanrilkefusp alfa
Measured: Day 1 of Cycle 1
Characterization of Pre-dose Concentration of Nanrilkefusp Alfa on Day 1 of Cycle 1
At 9 µg/kg nanrilkefusp alfa
Measured: Day 1 of Cycle 1
Incidence of Treatment-induced Anti-drug Antibodies Against Nanrilkefusp Alfa
At 9 µg/kg and 12 µg/kg nanrilkefusp alfa
Measured: Day 1 until 30 (±2) days after the last dose of nanrilkefusp alfa, up to approximately 1 year 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start22 Dec 2022
- Primary completion6 Mar 2024
- Study completion5 Jun 2024
Why it stopped: Due to lack of efficacy shown at the time of the interim analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- SOTIO Biotech AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619172
- Sponsor's protocol ID
- SC105
- Other IDs
- AURELIO-05, 2022-001527-32
- Status last verified
- Jul 2025
- First submitted
- 1 Nov 2022
- Last updated
- 24 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of SOT101 in Combination With Cetuximab in Patients With RAS Wild-type Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05619172
- Acronym / sponsor ID
- SC105
- Conditions
- Colorectal Cancer
- Keywords
- SOT101, SO-C101, Cetuximab, Colorectal cancer, AURELIO-05, Nanrilkefusp alfa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to lack of efficacy shown at the time of the interim analysis.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- SOTIO Biotech AGIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 6 Mar 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 16 Nov 2022 (actual)
- Results
- Posted 24 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nanrilkefusp alfa 9 µg/kg and cetuximab | Experimental | Drug: Nanrilkefusp alfa, Drug: CetuximabParticipants 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. |
| Nanrilkefusp alfa 12 µg/kg and cetuximab | Experimental | Drug: Nanrilkefusp alfa, Drug: CetuximabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- 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
Key exclusion criteria (24 listed)
- 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):
- 3.1. 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nanrilkefusp alfaSubcutaneous (SC) injection | Drug | Nanrilkefusp alfa 12 µg/kg and cetuximab, Nanrilkefusp alfa 9 µg/kg and cetuximab |
| CetuximabIntravenous (IV) infusion via peripheral or central venous line | Drug | Nanrilkefusp alfa 12 µg/kg and cetuximab, Nanrilkefusp alfa 9 µg/kg and cetuximab |
Primary outcome
Objective Response Rate According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
Time frame: Day 1 up to approximately 1 year 2 months
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.
30 secondary outcomes
Objective Response Rate According to RECIST for Immune-based Therapeutics (iRECIST)
Time frame: Day 1 up to approximately 1 year 5 months
Best Overall Response According to RECIST 1.1: Number of Participants With Complete Response
Time frame: Day 1 up to approximately 1 year 5 months
Best Overall Response According to RECIST 1.1: Number of Participants With Partial Response
Time frame: Day 1 up to approximately 1 year 5 months
Best Overall Response According to RECIST 1.1: Number of Participants With Stable Disease
Time frame: Day 1 up to approximately 1 year 5 months
Best Overall Response According to RECIST 1.1: Number of Participants With Progressive Disease
Time frame: Day 1 up to approximately 1 year 5 months
Best Overall Response According to iRECIST: Number of Participants With Complete Response
Time frame: Day 1 up to approximately 1 year 5 months
Best Overall Response According to iRECIST: Number of Participants With Partial Response
Time frame: Day 1 up to approximately 1 year 5 months
Best Overall Response According to iRECIST: Number of Participants With Stable Disease
Time frame: Day 1 up to approximately 1 year 5 months
Best Overall Response According to iRECIST: Number of Participants With Unconfirmed Progressive Disease
Time frame: Day 1 up to approximately 1 year 5 months
Best Overall Response According to iRECIST: Number of Participants With Confirmed Progressive Disease
Time frame: Day 1 up to approximately 1 year 5 months
Duration of Response According to RECIST 1.1
Time frame: Day 1 up to approximately 1 year 5 months
Duration of Response According to iRECIST
Time frame: Day 1 up to approximately 1 year 5 months
Clinical Benefit Rate According to RECIST 1.1
Time frame: Day 1 up to approximately 1 year 5 months
Clinical Benefit Rate According to iRECIST
Time frame: Day 1 up to approximately 1 year 5 months
Progression-free Survival According to RECIST 1.1
Time frame: Day 1 up to approximately 1 year 5 months
Progression-free Survival According to iRECIST
Time frame: Day 1 up to approximately 1 year 5 months
Time to Response According to RECIST 1.1
Time frame: Day 1 up to approximately 1 year 5 months
Time to Response According to iRECIST
Time frame: Day 1 up to approximately 1 year 5 months
Time to Progression According to RECIST 1.1
Time frame: Day 1 up to approximately 1 year 5 months
Time to Progression According to iRECIST
Time frame: Day 1 up to approximately 1 year 5 months
Number of Participants With Treatment-emergent Adverse Events
Time frame: Day 1 up to approximately 1 year 5 months
Number of Participants With Clinical Laboratory Test Abnormalities (Coagulation, Hematology, Clinical Chemistry and Urinalysis)
Time frame: Day 1 up to approximately 1 year 5 months
Number of Participants With Vital Signs Abnormalities
Time frame: Day 1 up to approximately 1 year 5 months
Number of Participants With Electrocardiography Abnormalities
Time frame: Day 1 up to approximately 1 year 5 months
Number of Participants With Dose-limiting Toxicities (DLTs)
Time frame: Through Cycle 1 (21 days)
Characterization of Area Under the Curve of Nanrilkefusp Alfa
Time frame: Day 1 of Cycle 1
Characterization of Maximum Concentration of Nanrilkefusp Alfa on Day 1 of Cycle 1
Time frame: Day 1 of Cycle 1
Characterization of Time to Maximum Concentration of Nanrilkefusp Alfa on Day 1 of Cycle 1
Time frame: Day 1 of Cycle 1
Characterization of Pre-dose Concentration of Nanrilkefusp Alfa on Day 1 of Cycle 1
Time frame: Day 1 of Cycle 1
Incidence of Treatment-induced Anti-drug Antibodies Against Nanrilkefusp Alfa
Time frame: Day 1 until 30 (±2) days after the last dose of nanrilkefusp alfa, up to approximately 1 year 5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nanrilkefusp alfa and Cetuximab in people with Colorectal Cancer, run by SOTIO Biotech AG at 8 sites in 3 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 29 inclusion and 24 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 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, Belgium, France. 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 24 Jul 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?
Objective Response Rate According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) (time frame: Day 1 up to approximately 1 year 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2025.