← Back to Search

Monoclonal Antibodies

SOT201 for Metastatic Cancer

Edegem, Belgium

Phase 1

Recruiting

Led By Aung Naing, MD, FCAP

Research Sponsored by SOTIO Biotech AG

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Performance status: Eastern Cooperative Oncology Group (ECOG) performance score 0-1

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a drug to treat advanced, unresectable cancer. It will assess safety, tolerability & effectiveness, and determine best dose given every 3 weeks.

See full description

Who is the study for?

Adults with advanced or metastatic solid tumors that have worsened after standard treatments can join this trial. They must be able to provide a fresh tumor biopsy, have an ECOG score of 0-1 indicating they are fully active or restricted in physically strenuous activity but ambulatory, and their organs must function well. People who've had severe reactions to certain immune therapies or recent radiation, those with specific heart issues, autoimmune diseases needing treatment within the last two years, active infections requiring therapy (except HIV/Hepatitis B), or life expectancy under three months cannot participate.Check my eligibility

What is being tested?

The study is testing SOT201 as a solo treatment for cancer patients every three weeks. It's in Phase 1 where researchers will figure out the best dose based on safety and how well it works at different levels.See study design

What are the potential side effects?

Since this is an early-phase trial for SOT201, exact side effects aren't listed but may include typical reactions to cancer drugs like fatigue, nausea, skin reactions and potential immune-related conditions due to its nature as an immunotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer has spread and gotten worse after treatment.

show original

Select...

I am fully active or can carry out light work.

show original

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I had a severe reaction to previous immunotherapy that made me stop treatment.

show original

Select...

I have not taken drugs that affect immune system signals before signing the consent form.

show original

Select...

I have not taken any medication that is not allowed in this trial.

show original

Select...

I have serious heart problems.

show original

Select...

I am not on high-dose steroids or other drugs that weaken my immune system.

show original

Select...

I haven't needed systemic treatment for an autoimmune disease in the last 2 years.

show original

Select...

I have or had lung inflammation that needed steroids.

show original

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.