Phase 2 Bladder Cancer Trial, Recruiting NCT05710848 Sponsor: SURGE Therapeutics Condition: Bladder Cancer
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Phase 2 Bladder Cancer Trial, Recruiting

NCT05710848
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:

  • People aged 18 years or older
  • People who have been diagnosed with high-grade non-muscle-invasive bladder cancer (a type of bladder cancer that has not spread into the bladder muscle), specifically classified as Ta or T1, without a type called CIS — who have already completed standard treatment, whose cancer has come back (shown by a camera examination of the bladder), and who are scheduled for a surgical procedure to remove bladder tumours without chemotherapy applied inside the bladder during that procedure
  • People considered to be at high risk of their bladder cancer coming back
  • People who have a general physical fitness level rated as 0, 1, or 2 on a standard medical scale (meaning ranging from fully active to capable of self-care but limited in physical activity) (confirm with trial site)
  • People whose blood counts and organ function meet specific minimum levels for red blood cells, white blood cells, platelets, liver function, and kidney function, as determined by laboratory tests (confirm with trial site)

Who may not be able to join:

  • People who have a history of a specific type of bladder cancer called carcinoma in situ (CIS), or bladder cancer that has grown into the bladder muscle (MIBC)
  • People who are currently taking part in another clinical trial involving an experimental treatment
  • People who have had allergic reactions to compounds chemically or biologically similar to the study drug (resiquimod/R848), or to specific ingredients used in the trial treatment called poloxamer 407 or sodium hyaluronate
  • People who have a serious or uncontrolled illness, such as an active infection, heart failure, unstable chest pain, irregular heartbeat, or a mental health or social situation that would make it difficult to follow the study requirements — note that urinary tract infections are not automatically disqualifying unless they are severe (confirm with trial site)
  • Women who are able to become pregnant, regardless of contraceptive use — this applies to the early phases of this trial only; later phases of the study are expected to include this group (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

Principal Investigator: Seth Lerner, MD, Baylor College of Medicine

Phone: 781-605-8632

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
SURGE Therapeutics
Registry
ClinicalTrials.gov
Start date
11 July 2023
Est. completion
1 May 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] Phase 1; Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Phase 1; Recurrence free survival time (Phase 2a)

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