Actively Recruiting
A Study to Assess Safety and Efficacy of SOT201 in Patients With Advanced/Metastatic Cancer
Led by SOTIO Biotech AG · Updated on 2025-06-29
40
Participants Needed
7
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study to Assess Safety and Efficacy of SOT201 in Patients With Advanced/Metastatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with advanced or metastatic solid tumors confirmed by tissue diagnosis
- Disease progression after treatment with therapies known to provide clinical benefit
- Measurable disease per RECIST 1.1 criteria
- Accessible tumor tissue available for fresh biopsy or willing to undergo biopsy if safe
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Recovery from previous treatment side effects to grade 1 or less toxicity (except hair loss), or stable grade 2 neuropathy
- Adequate organ function at screening and before first dose of SOT201
You will not qualify if you...
- Severe intolerance or hypersensitivity to anti PD-1, anti-PD-L1 therapies, pembrolizumab, or related agents causing permanent discontinuation or unresolved severe reactions
- Prior exposure to drugs affecting IL-2, IL-4, IL-7, IL-8, IL-9, IL-12, IL-15, IL-18, IL-21 or IL-27 before consent
- Recent systemic anti-cancer therapy within specified washout periods (less than 3 weeks for chemotherapy, less than 3 weeks or 5 half-lives for biologics, less than 4 weeks for immune checkpoint inhibitors)
- Recovery not adequate from major surgeries within 4 weeks before treatment
- Radiation therapy within 14 days before treatment or unresolved side effects
- Use of prohibited medications before or during the trial
- Life expectancy less than 3 months
- Significant heart problems
- Allogeneic hematopoietic stem cell transplant within 5 years or symptoms of graft versus host disease
- Immunodeficiency or systemic steroid/immunosuppressive therapy within 7 days before first dose
- Additional active malignancy requiring treatment within past 5 years (except certain skin or in situ cancers)
- Active central nervous system metastases or carcinomatous meningitis unless stable and steroid-free
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis/interstitial lung disease requiring steroids
- Active infection needing systemic therapy except HIV or Hepatitis B
- Any condition or treatment that may interfere with study participation or results as judged by investigators
AI-Screening
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Trial Site Locations
Total: 7 locations
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
2
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, Antwerp, Belgium, 2650
Actively Recruiting
3
Institut Jules Bordet
Anderlecht, Brussels Capital, Belgium, 1070
Actively Recruiting
4
Masarykův Onkologický Ústav
Brno, Czechia
Actively Recruiting
5
Fakultni Nemocnice Olomouc (FNOL) - Onkologicka Klinika
Olomouc, Czechia, 779 00
Withdrawn
6
Institut Gustave Roussy
Paris, France, 94805
Not Yet Recruiting
7
Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO)
Barcelona, Spain, 08035
Actively Recruiting
Research Team
R
Richard Kapsa
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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