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Study of SOT201 for Advanced/Metastatic Solid Tumors

This study is testing a drug called SOT201 for people with advanced or metastatic (spread to other parts of the body) solid tumors. You might be able to join if your cancer has progressed after other treatments. The main goals are to see how safe SOT201 is and what side effects it might cause. Researchers will also look at how well SOT201 works against cancer. This is a dose-escalation study, meaning different doses of SOT201 will be tested to find the best one. The study is currently recruiting, with a plan to enroll 40 participants.

Study design
This is a Phase 1, open-label (meaning both you and the study team will know what treatment you are receiving) study. It aims to enroll 40 participants.
What's involved
You would have a screening period of up to 21 days, possibly longer. You would then receive continuous intravenous (IV) infusions of SOT201 every three weeks until your disease progresses or you experience unacceptable side effects.
Compensation
Not stated in the trial record.
Follow-up
After stopping SOT201, you would be followed for about 90 days, or until your disease progresses, you start new cancer treatment, or you withdraw consent.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06163391

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
SOTIO Biotech AG
~40 participants
Updated 2025-06-29 on ClinicalTrials.gov
What's tested:SOT201

At a glance

Recruiting sites
5 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number and percentages of participants with treatment-emergent adverse events (TEAEs)
Measured over from patient signing the ICF up to 90 (+7) days after the last dose of SOT201, assessed approximately up to 3 years
+1 more outcome measured

Conditions

Advanced Solid Tumor
Metastatic Solid Tumor

Explore related trials

Solid Neoplasm

NCT06163391

Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

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

    Barcelona, Spainstudy coordinator listed

    Recruiting

  • Institut Jules Bordet

    Anderlecht, Brussels Capital, Belgiumstudy coordinator listed

    Recruiting

  • Masarykův Onkologický Ústav

    Brno, Czechiastudy coordinator listed

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

  • Universitair Ziekenhuis Antwerpen (UZA)

    Edegem, Antwerp, Belgiumstudy coordinator listed

    Recruiting

  • Institut Gustave Roussy

    Paris, Franceno site contact published

    Not yet recruiting

  • Fakultni Nemocnice Olomouc (FNOL) - Onkologicka Klinika

    Olomouc, Czechiano site contact published

    Withdrawn

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Aung Naing, MD, FCAP · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Richard Kapsa
[email protected]
(+420) 2241 74448
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number and percentages of participants with treatment-emergent adverse events (TEAEs)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)21 days of Cycle 1 plus 7 days of cycle 2 per cycle

    DLTs will be defined using NCI CTCAE version 5.0