Is NCT06163391 recruiting in Houston, TX?

Yes, NCT06163391 is currently recruiting participants at its Houston, TX location. This advanced solid tumor clinical trial is actively enrolling qualified participants.

How do I join the advanced solid tumor clinical trial in Houston?

To join this clinical trial in Houston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Houston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Advanced Solid Tumor Clinical Trial in Houston, TX

About This Advanced Solid Tumor Study in Houston

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

Sponsor: SOTIO Biotech AG

Who Can Participate

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 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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT06163391) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Advanced Solid Tumor Treatment Options in Houston, TX

If you're searching for advanced solid tumor treatment options in Houston, TX, this clinical trial (NCT06163391) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced advanced solid tumor specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all advanced solid tumor clinical trials near you to find additional studies recruiting in your area.

Advanced Solid Tumor Clinical Trial in Houston, TX

Expert Care in Houston

IRB Approved

No-Cost Care

Apply for This Houston Location

Why Participate?

Simple Process