Phase 2 Bladder Cancer Trial, Recruiting NCT07186842 Sponsor: BioNTech SE Condition: Bladder Cancer
Back to Bladder Cancer

Phase 2 Bladder Cancer Trial, Recruiting

NCT07186842
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 able to carry out normal daily activities with little or no limitation (based on a standard performance scale used by doctors)
  • Your cancer can be measured on scans using standard medical guidelines
  • Your doctor believes you are expected to live for at least 3 months
  • Your organs (such as liver and kidneys), blood clotting, and blood cell counts are working well enough as set out in the trial requirements
  • (For most parts of the trial) You have been confirmed by biopsy to have an advanced or spread form of one of these cancers: pancreatic cancer, bile duct cancer, bladder or urinary tract cancer, colorectal cancer, cancer of the junction between the oesophagus and stomach, womb cancer, or ovarian/fallopian tube/peritoneal cancer (not mesothelioma)
  • (For most parts of the trial) You have already tried all standard treatments available to you, including any targeted therapies suitable for your cancer type, and those treatments have stopped working
  • (For one specific part of the trial — Part D only) You have a confirmed diagnosis of pancreatic cancer and have had at least one previous treatment for advanced disease

Who may not be able to join:

  • You are currently taking part in another clinical trial or are still within a waiting period after a previous trial
  • You have not waited long enough since your last cancer treatment before starting this trial (the required gap is defined in the trial protocol)
  • You have taken high-dose steroid tablets or other medicines that suppress the immune system in the 2 weeks before starting the trial (some exceptions apply, such as steroid inhalers, skin creams, joint injections, low replacement doses, or steroids used to prevent allergic reactions — confirm with trial site)
  • You have received a live vaccine in the 4 weeks before starting the trial, or plan to have one during the trial
  • You have cancer that has spread to the brain or is pressing on the spinal cord, unless it has been treated and is stable without steroids or anti-seizure medicines for at least 2 weeks (confirm with trial site)
  • You have a history of, or currently have, a lung condition called interstitial lung disease or pneumonitis that requires steroids, or where this condition cannot be ruled out on scans
  • You have active stomach or intestinal ulcers, ulcerative colitis, or other gut conditions that your doctor thinks could cause bleeding or a tear in the gut
  • You have an active infection that needed treatment with medicines in the week before starting the trial (people on preventative anti-infection medicines may still be eligible — confirm with trial site)
  • You still have unresolved side effects from a previous cancer treatment, as defined in the trial protocol

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: BioNTech Response Person, BioNTech SE

Phone: +49 6131 9084

Australian sites

Monash Health, Clayton,
Austin Health, Heidelberg,

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
Sponsor
BioNTech SE
Registry
ClinicalTrials.gov
Start date
18 November 2025
Est. completion
1 May 2030

Where this trial is recruiting

🇦🇺 Australia 🇩🇪 Germany 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Parts A and B - Occurrence of dose-limiting toxicities within a participant; Parts A, B, and D - Occurrence of treatment-emergent adverse events (TEAEs), Grade ≥3 TEAEs, serious adverse events (SAEs), treatment-related TEAEs, treatment-related Grade ≥3 TEAEs, and treatment-related SAEs; Parts A, B, and D - Occurrence of dose interruptions, reductions, and discontinuation of BNT329 due to TEAEs; Part D - Objective response rate (ORR)

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