Phase 2 Prostate Cancer Trial, Recruiting NCT04104776 Sponsor: Novartis Pharmaceuticals Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT04104776
Recruiting Phase 2

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:

  • Adults aged 18 or older who are expected to live for at least 12 weeks
  • People who are generally well enough to carry out daily activities with little or no limitation (as measured by a standard medical scale called ECOG 0–1)
  • People who have mostly recovered from side effects of previous cancer treatments
  • People whose bone marrow, kidneys, and liver are functioning well enough to meet the trial's specific requirements
  • People who are willing to provide tumour tissue and blood samples for research testing
  • People who agree to follow the trial's requirements around contraception during the study
  • People who have given their written agreement (informed consent) to take part before any study procedures begin

For the early phase of the trial (Phase 1 – finding the right dose):

  • People with an advanced or spreading solid tumour or lymphoma that has been confirmed through laboratory testing of a tissue or cell sample
  • People whose cancer has stopped responding to standard treatments, or for whom no effective standard treatment is available
  • People with prostate cancer must have testosterone levels kept at castrate levels throughout the study

For the later phase of the trial (Phase 2 – disease-specific groups):

  • People with a specific gene change (ARID1A mutation) in bladder/urinary tract cancer or other solid tumours, with measurable disease and specific prior treatment requirements (confirm with trial site)
  • People with ARID1A-mutant ovarian clear cell cancer who have previously had platinum-based chemotherapy, and bevacizumab unless it was medically unsuitable for them
  • People with ARID1A-mutant endometrial (womb) cancer that has returned or spread, after receiving platinum-based chemotherapy and appropriate immunotherapy
  • People with certain types of lymphoma (peripheral T cell lymphoma or diffuse large B cell lymphoma) that have returned or stopped responding to treatment, who are not suitable for a stem cell transplant, and who have measurable disease
  • People with pleural or peritoneal mesothelioma (cancer of the lining of the lungs or abdomen) that has returned or spread, with a confirmed loss of a protein called BAP1
  • People with prostate cancer that has spread and is no longer responding to hormone-lowering treatment, and whose cancer continued to grow after both hormone-blocking therapy and taxane chemotherapy
  • People with endometrial cancer without the ARID1A gene change (this is an exploratory group studying the effect of food on the treatment) (confirm with trial site)
  • People with advanced prostate cancer no longer responding to hormone treatment, who are being treated with the study drug DZR123 together with enzalutamide, and who meet specific prior treatment requirements (confirm with trial site)

Who may not be able to join:

  • People who have previously had a solid organ transplant or a bone marrow/stem cell transplant from a donor
  • People with cancer that has spread to the brain or spinal cord that is active or causing symptoms and has not been treated (some limited exceptions may apply — confirm with trial site)
  • People with significant heart conditions, including uncontrolled irregular heartbeats or a specific abnormality seen on a heart tracing (prolonged QTc)
  • People with active lung inflammation (interstitial lung disease or pneumonitis)
  • People with infections that are not under control, or serious digestive system problems that could affect how the body absorbs the treatment
  • People with active HIV, hepatitis B, or hepatitis C infection
  • People who have another cancer that currently requires active treatment (some exceptions may apply — confirm with trial site)
  • People who are pregnant, breastfeeding, or unable to follow the trial's requirements
  • People who have had recent cancer treatments that fall within certain time limits set by the trial (confirm with trial site for specific timeframes)
  • People who have previously been treated with a type of drug called an EZH2 inhibitor
  • People who have had recent radiation therapy or procedures targeting the liver, outside the trial's allowed timeframes
  • People who are taking certain medicines that strongly affect how the body processes drugs (known as strong CYP3A4/5 inhibitors or inducers)

Additional restrictions for specific groups:

  • For the prostate cancer group (M6): People whose cancer is only visible in bone with no other measurable areas, people with unstable bone lesions, people using herbal products that may lower PSA levels, or people who have recently had certain prostate cancer treatments
  • For the combination treatment group (M8): People whose cancer is only showing up through PSA blood test changes with no visible disease, people who have previously taken certain investigational hormone-blocking drugs, people with a significant risk of seizures, people who have had extensive prior radiation to the bone marrow, or people with active inflammatory bowel or digestive conditions

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 27 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

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
18 September 2019
Est. completion
27 February 2030

Where this trial is recruiting

🇫🇷 France 🇮🇹 Italy 🇵🇱 Poland 🇰🇷 South Korea 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Tulmimetostat Monotherapy Phase 1: Frequency of Dose-limiting toxicities (DLTs); Tulmimetostat Monotherapy Phase 2: Overall response rate (ORR); Cohort M8 Part 1: Frequency of Dose-limiting toxicities (DLTs); Cohort M8 Part 2: Prostate-Specific Antigen 50 (PSA50) Response

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: 27 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