A Study to Assess Safety and Efficacy of SOT201 in Patients With Advanced/Metastatic Cancer

NCT ID: NCT06163391

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-10-31

Brief 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) 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.

Conditions

Advanced Solid Tumor; Metastatic Solid Tumor

Study Design

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

Study Groups

SOT201

SOT201 will be administered intravenously once every 21 days

Group Type: EXPERIMENTAL

SOT201

Intervention Type: DRUG

intravenous infusion

Interventions

SOT201

intravenous infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Type of patients

• Patients with histologically or cytologically confirmed advanced or metastatic solid tumors who have disease progression after treatment with available therapies for their disease that are known to confer clinical benefit
• Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology; lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
• Accessible tumor tissue available for fresh biopsy or being considered for tumor biopsy according to the treating institution's guidelines and willing to undergo a new biopsy if not clinically contraindicated Note: Newly obtained tumor tissue (to be taken at baseline) is preferred to an archival sample. All tumor biopsies will be collected from the same target lesion, if possible. Archived, fixed tumor tissue may only be collected (taken ideally after completion of the most recent systemic tumor therapy and within 6 months prior to the first dose of trial treatment) if fresh biopsy at screening cannot be retrieved from patients due to safety concerns.
• Performance status: Eastern Cooperative Oncology Group (ECOG) performance score 0-1
• Must have recovered from all adverse events (AEs) due to previous therapies to grade ≤1 toxicity (excluding alopecia) or have stable grade 2 neuropathy as per investigators judgement Note: grade >1 immune- related AEs to any prior treatments may be accepted if considered clinically nonsignificant and/or clinically stable on supportive therapy.
• Organ function: Have adequate organ function during screening and prior to first SOT201 dose.

Exclusion Criteria

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
• 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

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

Sponsors

SOTIO Biotech AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aung Naing, MD, FCAP

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

MD Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Universitair Ziekenhuis Antwerpen (UZA)

Edegem, Antwerp, Belgium

Site Status: RECRUITING

Institut Jules Bordet

Anderlecht, Brussels Capital, Belgium

Site Status: RECRUITING

Masarykův Onkologický Ústav

Brno, , Czechia

Site Status: RECRUITING

Fakultni Nemocnice Olomouc (FNOL) - Onkologicka Klinika

Olomouc, , Czechia

Site Status: WITHDRAWN

Institut Gustave Roussy

Paris, , France

Site Status: NOT_YET_RECRUITING

Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO)

Barcelona, , Spain

Site Status: RECRUITING

Countries

United States; Belgium; Czechia; France; Spain

Central Contacts

Richard Kapsa

Role: CONTACT

kapsa@sotio.com

(+420) 2241 74448

Facility Contacts

Aung Naing, MD, FACP

Role: primary

anaing@mdanderson.org

713-563-3885

Amelie Lyssens

Role: primary

amelie.lyssens@uza.be

3238215580

Ghenwa El Hajj

Role: primary

ghenwa.elhajj@hubruxelles.be

3225413145

Katerina Vavrouchova

Role: primary

katerina.vavrouchova@mou.cz

420543136220

Elena Garralda, MD

Role: primary

0034932746000

Role: backup

egarralda@vhio.net

References

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.

Reference Type: DERIVED

PMID: 40250867 (View on PubMed)

Other Identifiers

VICTORIA-01

Identifier Type: OTHER

Identifier Source: secondary_id

2023-504330-21-00

Identifier Type: OTHER

Identifier Source: secondary_id

SC201

Identifier Type: -

Identifier Source: org_study_id