Phase 1 Bladder Cancer Trial, Recruiting NCT07660055 Sponsor: Novartis Pharmaceuticals Condition: Bladder Cancer
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Phase 1 Bladder Cancer Trial, Recruiting

NCT07660055
Recruiting Phase 1 🇦🇺 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:

  • Adults aged 18 or older
  • People with a confirmed diagnosis of certain advanced cancers that have continued to grow or spread after standard treatments, and where no other standard treatment with proven benefit is considered appropriate by the treating doctor
  • People with advanced HER2-positive breast cancer that has progressed after at least two prior treatment courses for advanced disease (in both the dose escalation and dose expansion parts of the trial)
  • People with advanced breast cancer that is hormone receptor-positive and HER2-low, where the cancer has progressed after prior treatment for advanced disease
  • People with advanced breast cancer that is hormone receptor-positive with very low or no HER2 expression, where the cancer has progressed after prior treatment (dose expansion part only)
  • People with advanced breast cancer that is hormone receptor-negative and HER2-low, where the cancer has progressed after prior treatment (dose expansion part only)
  • People with advanced breast cancer that is hormone receptor-negative with very low or no HER2 expression, where the cancer has progressed after prior treatment (dose expansion part only)
  • People with advanced non-small cell lung cancer (a type of lung cancer), either with or without certain specific genetic changes, who have already received prior treatment
  • People with advanced stomach or gastroesophageal junction cancer with certain HER2 protein expression levels, where the cancer has progressed after prior treatment for advanced disease (dose expansion part only)
  • People whose cancer can be measured using standard imaging guidelines (called RECIST version 1.1)

Who may not be able to join:

  • People whose blood test results fall outside acceptable ranges, including problems with kidney function, liver function, certain digestive enzymes, or blood cell counts (confirm specific thresholds with trial site)
  • People who have started certain medications to boost blood cell production within 2 weeks before receiving the trial imaging agent
  • People who have received a blood transfusion within 4 weeks before receiving the trial imaging agent
  • People with significant heart problems or serious heart disease
  • People with severe urinary blockage or unmanageable bladder control problems
  • People with a serious infection that is not under control
  • People who are pregnant or breastfeeding
  • People who have previously been treated with any radioactive cancer treatment (radiopharmaceutical therapy)
  • People who have received certain other radioactive imaging agents, radiation therapy to the chest area, or other radiation treatments within specified time periods before the trial (confirm exact timeframes with trial site)
  • People whose pre-trial scan shows uptake of the trial's imaging agent in areas of the body that the treating doctor believes could make the treatment unsafe

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 12 July 2026
Phase 1: approximately ~10% 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

Phone: 1-888-669-6682

Australian sites

Novartis Investigative Site, Darlinghurst, 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 1
Registry
ClinicalTrials.gov
Start date
16 June 2026
Est. completion
24 May 2032

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇯🇵 Japan

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

Primary endpoints

Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) of [177Lu]Lu-DWJ155; Incidence of dose-limiting toxicities (DLTs) of [177Lu]Lu-DWJ155; Frequency of dose interruptions and reductions [177Lu]Lu-DWJ155; Dose intensity [177Lu]Lu-DWJ155

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: 12 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