Advanced Solid TumorPhase 1NCT06163391
A Study to Assess Safety and Efficacy of SOT201 in Patients With Advanced/Metastatic Cancer
A Phase 1 study testing SOT201 in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by SOTIO Biotech AG at 6 sites in 5 countries.
Trial summary
This is a Phase 1, open-label, dose escalation study to assess the safety, tolerability, and preliminary efficacy of SOT201 as monotherapy for participants aged 18 years or above with advanced unresectable or metastatic solid tumors During dose escalation, the recommended dose(s) of SOT201 given every 3 weeks (Q3W)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Metastatic Solid Tumor
- What is being tested?
- SOT201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 1 May 2024to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
None listed.
Who cannot join
- Prior/concomitant therapy
- Known clinically relevant intolerability or severe hypersensitivity to prior anti PD-1 or anti-PD-L1 agent therapy, pembrolizumab and/or any of its excipients, or an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, CD134 [OX40], CD137) that caused permanent discontinuation of the agent, or that were grade 4 in severity or have not resolved to grade ≤1.
- Prior exposure to drugs that are agonists or antagonists of IL-2, IL-4, IL-7, IL-8, IL-9, IL-12, IL-15, IL-18, IL-21 or IL-27 prior to ICF signature.
- Prior systemic anti-cancer therapies, including investigational agents, prior to day 1 cycle 1 signature if not otherwise indicated:
- Less than 3 weeks for all systemic chemotherapy
- Less than 3 weeks or 5 half-lives (whichever shorter) for any biologic agents
Show all 21Show fewer
- Less than 4 weeks for ICIs (targeting CTLA-4, or PD-L1, including e.g., ipilimumab, atezolizumab, avelumab, durvalumab, cemiplimab) prior to cycle 1 day 1
- Less than 4 weeks from major surgeries and not recovered adequately from the procedure and/or any complications from the surgery before starting SOT201
- Has received radiation therapy ≤14 days before day 1 of cycle 1 or has not recovered to grade ≤1 from treatment-related side effects. A 1-week radiation-free period is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system disease.
- Use of prohibited medication prior or during the course of the trial as specified in the protocol
- Predicted life expectancy ≤3 months
- Clinically significant cardiac abnormalities
- Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years (patients who have had a transplant more than 5 years ago are eligible as long as there are no symptoms of graft versus host disease)
- Diagnosis of other forms 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 before the first dose of SOT201
- 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 not excluded.
- 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 by repeat imaging (note that the repeat imaging should be performed during trial screening), clinically stable and without requirement of steroid treatment for at least 14 days before the first dose of SOT201.
- 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 a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has an active infection requiring systemic therapy, except in cases for treatment of HIV and/or Hepatitis B
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator
- NOTE: Other Inclusion/Exclusion criteria may apply. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Belgium2 sites
Institut Jules Bordet
Anderlecht, Brussels Capital, 1070
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, Antwerp, 2650
Spain1 site
Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO)
Barcelona, 08035
About this study
Official title: A Multicenter, Open-label, Phase 1 Study to Evaluate the Safety and Preliminary Efficacy of SOT201 in Patients With Advanced/Metastatic Solid Tumors
This is a Phase 1, open-label, dose escalation study to assess the safety, tolerability, and preliminary efficacy of SOT201 as monotherapy for participants aged 18 years or above with advanced unresectable or metastatic solid tumors
During dose escalation, the recommended dose(s) of SOT201 given every 3 weeks (Q3W) will be determined
Read the detailed description
Duration of the study for a participant will include:
Screening period: Up to 21 days before day 1 of cycle 1 (can be prolonged up to 42 days, if required due to fresh biopsy) Treatment Period: enrolled and exposed participants will receive continuous treatment until progressive disease (PD), or an occurrence of an unacceptable AE, a withdrawal of consent, or until other permanent discontinuation criteria described in the protocol are met.
End of treatment will occur within 7 (+7) days after the SOT201 discontinuation, and Follow-up period.
Every 30 (±2) days until 90 (+7) days after the final dose of SOT201, until disease progression, the start of new anticancer therapy, death, or withdrawal of participant's consent, whichever comes first.
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor
- Being tested
- SOT201
- Keywords
- Checkpoint inhibition plus RLI-15, SOT201, SC201, VICTORIA-01, RLI-15/CPI fusion protein, Immunocytokine
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOT201Drug
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| SOT201 | Experimental | SOT201 will be administered intravenously once every 21 days Receives: Drug: SOT201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentages of participants with treatment-emergent adverse events (TEAEs)
A TEAE is defined as an AE that started or worsened at or after the start of trial treatment Presence of TEAEs, SAEs, and lab abnormalities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Measured: from patient signing the ICF up to 90 (+7) days after the last dose of SOT201, assessed approximately up to 3 years
Number of participants with dose-limiting toxicities (DLTs)
DLTs will be defined using NCI CTCAE version 5.0
Measured: 21 days of Cycle 1 plus 7 days of cycle 2 per cycle
Secondary outcomes (9)
Characterization of area under the curve (AUClast, AUCinf, AUCtau) of SOT201
Area under the concentration versus time curve calculated using the trapezoidal method during a dosing interval (tau)
Measured: From Day 1 Cycle 1 to Cycle 3, from cycle 4 every other cycle (4, 6, 8), and from cycle 8 at quarterly frequency (11, 14, 17.) until cycle 20
Characterization of maximum concentration (Cmax) of SOT201
Maximum plasma concentration observed
Measured: Time Frame: From Day 1 of Cycle 1 to Cycle 3, from cycle 4 every other cycle (4, 6, 8), and from cycle 8 at quarterly frequency (11, 14, 17.) until cycle 20]
Characterization of time to maximum concentration (Tmax) of SOT201
Time to maximum concentration of SOT201
Measured: From Day 1 of Cycle 1 to Cycle 3, from cycle 4 every other cycle (4, 6, 8), and from cycle 8 at quarterly frequency (11, 14, 17..) until cycle 20
Characterization of pre-dose concentration (Ctrough) of SOT201
Pre-dose trough SOT201 concentrations
Measured: From Day 1 of Cycle 1 to Cycle 3, from cycle 4 every other cycle (4, 6, 8), and from cycle 8 at quarterly frequency (11, 14, 17..) until cycle 20
Objective response rate (ORR)
Proportion of patients who have a confirmed complete response (CR) or a partial response (PR), as the best overall response (BOR) determined by the Investigator as per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: From Day 1 of Cycle 1 until disease progression or start new anticancer therapy, whichever comes first, assess to up to approximately 3 years
Duration of response (iDoR)
DoR is defined as the time from first documented evidence of confirmed CR or PR until progressive disease (PD) determined by Investigator per RECIST 1.1 or death from any cause, whichever occurs first
Measured: From Day 1 of Cycle 1 until disease progression or start new anticancer therapy, whichever comes first, assess to up to approximately 3 years
Clinical benefit rate (iCBR)
including confirmed CR or PR at any time or stable disease (SD) of at least 6 months determined by Investigator per RECIST 1.1
Measured: From Day 1 of Cycle 1 until disease progression or start new anticancer therapy, whichever comes first, assess to up to approximately 3 years
Progression-free survival (iPFS)
PFS is defined as the time from the date of first administration of IMP to the date of the first documented disease progression determined by Investigator as per RECIST 1.1 or death from any cause, whichever occurs first
Measured: From Day 1 of Cycle 1 until disease progression or start new anticancer therapy, whichever comes first, assess to up to approximately 3 years
Incidence of anti-drug antibodies (ADAs) against SOT201
Incidence of patients with anti-drug antibodies
Measured: Day 1 until 30 (±2) days after the last dose of SOT201
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 May 2024
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 6 cohorts, multiple-dose escalation, Bayesian optimal interval design (BOIN) trial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SOTIO Biotech AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aung Naing, MD, FCAP, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163391
- Sponsor's protocol ID
- SC201
- Other IDs
- VICTORIA-01, 2023-504330-21-00, 2023
- Status last verified
- Oct 2026
- First submitted
- 30 Nov 2023
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Matuskova H, Marasek P, Mazhara V, Simonova E, Kosinova L, Danek P, Danova K, Sajnerova K, Malatova I, Hrabankova K, Greco D, Martinec O, Fabisik M, Podzimkova N, Hladikova K, Behalova K, Antosova Z, Sirova M, Mikyskova R, Reinis M, Kovar M, Bechard D, Moebius U, Palova Jelinkova L, Spisek R, Steegmaier M, Adkins I. Novel PD-1-targeted, activity-optimized IL-15 mutein SOT201 acting in cis provides antitumor activity superior to PD1-IL2v. J Immunother Cancer. 2025 Apr 17;13(4):e010736. doi: 10.1136/jitc-2024-010736.
PubMed 40250867
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Phase 1 Study to Evaluate the Safety and Preliminary Efficacy of SOT201 in Patients With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06163391
- Acronym / sponsor ID
- SC201
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor
- Keywords
- Checkpoint inhibition plus RLI-15, SOT201, SC201, VICTORIA-01, RLI-15/CPI fusion protein, Immunocytokine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- SOTIO Biotech AGIndustry (pharma, biotech, devices)
- Study start
- 1 May 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, open-label, dose escalation study to assess the safety, tolerability, and preliminary efficacy of SOT201 as monotherapy for participants aged 18 years or above with advanced unresectable or metastatic solid tumors
During dose escalation, the recommended dose(s) of SOT201 given every 3 weeks (Q3W) will be determined
Detailed description
Duration of the study for a participant will include:
Screening period: Up to 21 days before day 1 of cycle 1 (can be prolonged up to 42 days, if required due to fresh biopsy) Treatment Period: enrolled and exposed participants will receive continuous treatment until progressive disease (PD), or an occurrence of an unacceptable AE, a withdrawal of consent, or until other permanent discontinuation criteria described in the protocol are met.
End of treatment will occur within 7 (+7) days after the SOT201 discontinuation, and Follow-up period.
Every 30 (±2) days until 90 (+7) days after the final dose of SOT201, until disease progression, the start of new anticancer therapy, death, or withdrawal of participant's consent, whichever comes first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 6 cohorts, multiple-dose escalation, Bayesian optimal interval design (BOIN) trial
| Arm | Type | Receives |
|---|---|---|
| SOT201 | Experimental | Drug: SOT201SOT201 will be administered intravenously once every 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (21 listed)
- Prior/concomitant therapy
- Known clinically relevant intolerability or severe hypersensitivity to prior anti PD-1 or anti-PD-L1 agent therapy, pembrolizumab and/or any of its excipients, or an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, CD134 [OX40], CD137) that caused permanent discontinuation of the agent, or that were grade 4 in severity or have not resolved to grade ≤1.
- Prior exposure to drugs that are agonists or antagonists of IL-2, IL-4, IL-7, IL-8, IL-9, IL-12, IL-15, IL-18, IL-21 or IL-27 prior to ICF signature.
- Prior systemic anti-cancer therapies, including investigational agents, prior to day 1 cycle 1 signature if not otherwise indicated:
- Has received radiation therapy ≤14 days before day 1 of cycle 1 or has not recovered to grade ≤1 from treatment-related side effects. A 1-week radiation-free period is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system disease.
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 |
|---|---|---|
| SOT201intravenous infusion | Drug | SOT201 |
Primary outcome
Number and percentages of participants with treatment-emergent adverse events (TEAEs)
Time frame: from patient signing the ICF up to 90 (+7) days after the last dose of SOT201, assessed approximately up to 3 years
A TEAE is defined as an AE that started or worsened at or after the start of trial treatment Presence of TEAEs, SAEs, and lab abnormalities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Number of participants with dose-limiting toxicities (DLTs)
Time frame: 21 days of Cycle 1 plus 7 days of cycle 2 per cycle
DLTs will be defined using NCI CTCAE version 5.0
9 secondary outcomes
Characterization of area under the curve (AUClast, AUCinf, AUCtau) of SOT201
Time frame: From Day 1 Cycle 1 to Cycle 3, from cycle 4 every other cycle (4, 6, 8), and from cycle 8 at quarterly frequency (11, 14, 17.) until cycle 20
Characterization of maximum concentration (Cmax) of SOT201
Time frame: Time Frame: From Day 1 of Cycle 1 to Cycle 3, from cycle 4 every other cycle (4, 6, 8), and from cycle 8 at quarterly frequency (11, 14, 17.) until cycle 20]
Characterization of time to maximum concentration (Tmax) of SOT201
Time frame: From Day 1 of Cycle 1 to Cycle 3, from cycle 4 every other cycle (4, 6, 8), and from cycle 8 at quarterly frequency (11, 14, 17..) until cycle 20
Characterization of pre-dose concentration (Ctrough) of SOT201
Time frame: From Day 1 of Cycle 1 to Cycle 3, from cycle 4 every other cycle (4, 6, 8), and from cycle 8 at quarterly frequency (11, 14, 17..) until cycle 20
Objective response rate (ORR)
Time frame: From Day 1 of Cycle 1 until disease progression or start new anticancer therapy, whichever comes first, assess to up to approximately 3 years
Duration of response (iDoR)
Time frame: From Day 1 of Cycle 1 until disease progression or start new anticancer therapy, whichever comes first, assess to up to approximately 3 years
Clinical benefit rate (iCBR)
Time frame: From Day 1 of Cycle 1 until disease progression or start new anticancer therapy, whichever comes first, assess to up to approximately 3 years
Progression-free survival (iPFS)
Time frame: From Day 1 of Cycle 1 until disease progression or start new anticancer therapy, whichever comes first, assess to up to approximately 3 years
Incidence of anti-drug antibodies (ADAs) against SOT201
Time frame: Day 1 until 30 (±2) days after the last dose of SOT201
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Derived from this study: PubMed 40250867Matuskova H, Marasek P, Mazhara V, Simonova E, Kosinova L, Danek P, Danova K, Sajnerova K, Malatova I, Hrabankova K, Greco D, Martinec O, Fabisik M, Podzimkova N, Hladikova K, Behalova K, Antosova Z, Sirova M, Mikyskova R, Reinis M, Kovar M, Bechard D, Moebius U, Palova Jelinkova L, Spisek R, Steegmaier M, Adkins I. Novel PD-1-targeted, activity-optimized IL-15 mutein SOT201 acting in cis provides antitumor activity superior to PD1-IL2v. J Immunother Cancer. 2025 Apr 17;13(4):e010736. doi: 10.1136/jitc-2024-010736.
- 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.
Aung Naing, MD, FCAP principal investigator
M.D. Anderson Cancer Center
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SOT201 in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by SOTIO Biotech AG at 6 sites in 5 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 0 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, United States, Czechia, France, Spain. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Number and percentages of participants with treatment-emergent adverse events (TEAEs) (time frame: from patient signing the ICF up to 90 (+7) days after the last dose of SOT201, assessed approximately up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06163391, which also lists 1 linked publication.
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 14 Oct 2026.