SOLACE

NCT07197645

Age

Gender

Conditions

Learn about this study

A Phase 1 clinical study evaluating TLX090-Tx (SOLACE) — a potential new treatment designed to help relieve pain from cancer that has spread to the bones (metastatic bone pain).

This study is exploring how the medicine works in the body, what dose is safest, and whether it can help reduce pain and improve comfort for people living with advanced cancer.

Who can participate?

Participating in clinical research is a significant, personal decision. Before enrolling, the study team will fully explain the research and provide an Informed Consent Form (ICF) that outlines possible benefits and risks. This is your chance to ask questions and consult with your doctor to determine if the study is right for you.

You may be able to participate if:

  • Are 18 years or older
  • Have cancer that has spread to your bones and is causing pain (pain score ≥ 4)
  • Have bone metastases confirmed by a bone scan within 60 days
  • Are not currently receiving chemotherapy, and hormone or endocrine therapy is stable
  • Have adequate organ function and a life expectancy of at least 16 weeks
  • Are able to attend study visits and provide informed consent

You may not be able to participate if you:

  • Are pregnant or breastfeeding
  • Have untreated fractures, spinal cord compression, or an unstable spine
  • Have osteoporosis that increases fracture risk
  • Have serious heart conditions or significant abnormalities on an ECG
  • Have active infections (such as HIV, hepatitis A/B/C) or other conditions that could interfere with participation

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study. Please discuss with your doctor, on whether you may be able to participate in this study.

Locations

  • PI, Advisor – Dr. Ebrahim S. Delpassand, edelpassand@exceldiagnostics.com
    Clinical Research Coordinator – Dr. Mohammad Jawed Hashmi
    (MJ), mhashmi@exceldiagnostics.com
    Clinical Research Manager – Dr. Rouzbeh Esfandiari, resfandiari@exceldiagnostics.com

  • PI, Dr. Than John Van – tjvan21@yahoo.com
    Dir. Clinical Research – Lena Ellis lena.ellis@hmutx.com

  • PI – Dr. Julio Peguero, jpeguero@oncologyconsultants.com
    CRC: Dr. Luis Luna, lluna@oncologyconsultants.com
    Administrative Director of Research – Laura Guerra, lguerra@oncologyconsultants.com

Clinical Trials FAQs

  • Clinical trials are essential for validating new treatments and are designed to determine if treatments are safe and effective in people. These studies have formed the foundation for many modern medical advances, including in cancer imaging and therapy.

  • Clinical trials are conducted by physicians following strict protocols. Each study requires approval from review boards and regulatory agencies before beginning. Trials continuously monitor the safety of participants and collect data, with research teams carefully documenting every aspect of the patient’s response to treatment.

  • Participation depends on each study’s specific requirements. Trials often seek patients with particular conditions, with eligibility based on factors like age, medical history, and current health status.

  • Clinical trials generally progress through four phases:

    • Phase 1 tests if the treatment is safe and well tolerated in a small group (usually less than 50 patients); 
    • Phase 2 examines the effectiveness of the treatment (usually less than 100 patients); 
    • Phase 3 compares the effectiveness of the treatment against current approved treatments (more than 100 patients) and is typically the study which generates the data for the product to be approved by the regulatory body to be used in all patients; and
    • Phase 4 is conducted after a drug is approved, these trials gather further safety information in broader patient populations.

  • Clinical trials follow strict safety protocols and Good Clinical Practice guidelines. Multiple oversight layers, including review boards and monitoring committees, ensure participant safety. While no medical research is without risk, trials incorporate extensive safety measures and regular health monitoring to ensure the safety of participants.

  • This provides a detailed list of Telix’s active studies for a range of cancers. If you are unable to find a trial that is right for you here, clinicaltrials.gov offers a larger ranger of trials.  Major medical centers also offer trial matching services, and your healthcare professional can help identify suitable opportunities. Patient advocacy groups and disease-specific organizations also maintain information about relevant trials.

  • After completion of a trial, research teams analyse the results to assess the treatments effect. In the case of a Phase 3 trial, the findings are submitted to the regulatory body, typically the U.S. Food and Drug Administration or FDA, to support the approval of the treatment. Participants receive result summaries and may continue beneficial treatments through extended access programs while awaiting final approval.

The information provided on this website is for general informational purposes only and may not reflect all current or upcoming clinical trials being conducted with Telix’s investigational assets. While we strive to keep the content up to date, inclusion of a trial on this site does not guarantee its availability, eligibility criteria, or status. For the most accurate and comprehensive information, please consult ClinicalTrials.gov.

If you are an individual interested in potentially enrolling in a clinical trial, please contact your health care provider for more information about what trials may be right for you.