Phase 2 Bladder Cancer Trial, Recruiting NCT06378242 Sponsor: RemeGen Co., Ltd. Condition: Bladder Cancer
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Phase 2 Bladder Cancer Trial, Recruiting

NCT06378242
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:

  • You are willing to take part and have signed a consent form agreeing to participate in the study.
  • You are a man or woman between 18 and 75 years old (inclusive).
  • You have been diagnosed with a type of bladder cancer (called non-muscle invasive bladder urothelial carcinoma) that has been confirmed by a tissue biopsy and is classified as high-risk or very high-risk.
  • After a procedure to remove bladder tumors (called TURBT), there is no remaining removable tumor tissue (though a small surface-level cancer called CIS may still be present).
  • Your doctor has decided that removing the bladder surgically is not appropriate for you, or you have chosen not to have that surgery.
  • A test on your tumor tissue has shown a certain protein called HER2 at a level of 1+, 2+, or 3+.
  • You are generally able to carry out daily activities with little to no limitation, based on a standard health scale (confirm with trial site).
  • Your heart, blood, liver, kidney, and blood-clotting functions are all at healthy enough levels to participate.

Who may not be able to join:

  • Your bladder cancer has grown deeper into the bladder wall (stage T2 or higher) or has spread to lymph nodes or other parts of the body.
  • You have a related type of cancer in other parts of the urinary tract, such as the urethra, ureter, or kidney.
  • You have received any other cancer treatment within the 4 weeks before starting this study.
  • You are planning to have major surgery during the study or within 4 weeks before your first dose.
  • You have a known allergy to the study drug (called DV) or any of its ingredients (confirm with trial site).

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

Phone: +8610-58075763

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
RemeGen Co., Ltd.
Registry
ClinicalTrials.gov
Start date
14 June 2024
Est. completion
15 March 2029

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Incidence of dose-limiting toxicity(DLT) (Phase I); Incidence of Adverse event (Phase I); Recommended Phase II Dose(RP2D); Maximum Tolerated Dosage(MTD)

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