Phase 2 Spinal Muscular Atrophy Trial, Recruiting NCT07190300 Sponsor: Novartis Pharmaceuticals Condition: Spinal Muscular Atrophy
Back to Spinal Muscular Atrophy

Phase 2 Spinal Muscular Atrophy Trial, Recruiting

NCT07190300
Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are a man aged 18 or older who has been diagnosed with prostate cancer that has spread to other parts of the body (such as bones or soft tissue), either newly diagnosed or returning after previous treatment, and your cancer does not have certain rare, aggressive features (called neuroendocrine or small cell features).
  • Your testosterone levels have been reduced to very low levels (called "castrate levels") through hormone treatment.
  • You are reasonably active and able to carry out daily activities, ranging from fully active to capable of limited self-care (confirm with trial site for exact definition).
  • Your blood counts and organ function (such as kidneys and liver) are at acceptable levels, as determined by tests.
  • You started hormone-blocking therapy (called ADT) at least 1 month but no more than 12 months before joining the study, and you are willing to continue it during the trial.
  • You may have previously received a type of chemotherapy called a taxane for this condition, as long as your cancer did not progress while on it (certain limits apply depending on which part of the trial you join).
  • You may have previously taken a type of hormone therapy called an ARPI (androgen receptor pathway inhibitor), under certain conditions depending on when and how long you took it (confirm with trial site for details specific to your situation).
  • You may have previously had radiation therapy or surgery to the prostate, provided radiation was completed before joining and surgery was at least 2 weeks before joining.

Who may not be able to join:

  • Your prostate cancer has become resistant to hormone therapy (known as castration-resistant prostate cancer, or CRPC), or you only have a rising PSA without confirmed spread to other parts of the body, or your cancer is not causing symptoms and has not spread and your PSA has been normal for at least 1 year.
  • Your PSA level is very low — specifically below 0.5 ng/mL if you have not had prior ARPI treatment, or below 0.2 ng/mL if you have had or are currently on ARPI treatment.
  • Your cancer has spread to the brain, unless you have already been treated for it, your condition is stable, you have no symptoms, and you are not taking steroids to manage brain-related symptoms (confirm with trial site).
  • You are currently taking older-generation hormone-blocking drugs called first-generation anti-androgens (such as bicalutamide), unless you only took them briefly (14 days or less) at the very start of hormone therapy and stopped at least 7 days before joining.
  • You are taking a drug called ketoconazole specifically to treat your prostate cancer.
  • You have previously received a type of treatment called radioligand therapy.
  • You have taken part in another clinical trial and received an experimental treatment within the past 28 days (or longer, depending on the drug).
  • You have previously been treated with a specific class of drugs called PRC2 inhibitors (including EZH2 inhibitors or similar), which target a particular cancer-related process (confirm with trial site).
  • You have used herbal products known to lower PSA levels within 4 weeks before starting the study drug.
  • You are taking certain medications (such as strong CYP3A4 inducers or inhibitors) or herbal products that could interfere with the study drug and cannot be safely stopped before and during the trial (confirm with trial site for a full list of prohibited medications).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Phone: 1-888-669-6682

Australian sites

Novartis Investigative Site, Camperdown, New South Wales
Novartis Investigative Site, Wollongong, New South Wales

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
13 January 2026
Est. completion
2 August 2032

Where this trial is recruiting

🇦🇺 Australia 🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇫🇷 France 🇩🇪 Germany Hong Kong 🇭🇺 Hungary 🇮🇹 Italy 🇰🇷 South Korea 🇪🇸 Spain Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

2 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Phase I (Group A and Group B): Dose-limiting toxicities (DLTs); Phase I (Group A and Group B): Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs); Phase I (Group A and Group B): Number of Participants with dose adjustments; Phase I (Group A and Group B): Dose Intensity; Phase I (Group A and Group B): Duration of exposure to each study drug; Phase II (Group A): Prostate-Specific Antigen (PSA) response rate of < 0.2 ng/mL

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov