Phase 1 Bladder Cancer Trial, Recruiting NCT06644755 Sponsor: Daiichi Sankyo Condition: Bladder Cancer
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Phase 1 Bladder Cancer Trial, Recruiting

NCT06644755
Recruiting Phase 1

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 18 years of age or older
  • You have been diagnosed with one of the following cancers (confirmed by lab testing of tissue or cells): advanced or spread synovial sarcoma (SS), advanced or spread myxoid round cell liposarcoma (MRCLS), non-small cell lung cancer that has spread or cannot be removed by surgery (either adenocarcinoma or squamous cell types), or urothelial cancer (bladder/urinary tract cancer) that has spread or cannot be removed by surgery
  • Your cancer has come back, stopped responding to treatment, or you were unable to tolerate standard treatments available for your condition
  • You have a specific genetic marker called HLA-A*02 (in one of several specific subtypes) — this is determined by a blood test
  • Your cancer can be measured on a CT or MRI scan
  • You are willing and able to provide a tumor tissue sample (either a new biopsy or a previously stored sample)
  • Your general health and ability to carry out daily activities is rated as fully active or able to carry out light work (ECOG score of 0 or 1)
  • Your blood test results (taken within 14 days before starting the trial) meet specific minimum levels for liver function, blood cell counts, and kidney function (confirm exact values with trial site)
  • If you are a woman who could become pregnant: you are not currently pregnant, not breastfeeding, and agree to use highly effective birth control during the trial and for at least 120 days after the last dose
  • If you are a man who could father a child: you agree to use effective contraception and avoid donating sperm during the trial and for at least 120 days after the last dose

Who may not be able to join:

  • You have previously received any treatment that specifically targeted a protein called NY-ESO-1
  • You have received certain cancer treatments too recently before joining the trial — for example, radiation therapy within the last 4 weeks (or 2 weeks for certain limited radiation), chemotherapy or immunotherapy within the last 4 weeks, or certain targeted drug treatments within the last 2 weeks or 5 half-lives (whichever is longer)
  • You have brain or spinal cord spread of cancer that is causing symptoms (stable or successfully treated brain spread may be acceptable — confirm with trial site)
  • You have significant heart problems, such as a heart attack in the past 6 months, severe chest pain, serious heart failure, reduced heart pumping function, or an abnormal heart rhythm measurement on an ECG (confirm details with trial site)
  • You are currently taking regular steroid medicines (such as prednisone above a low dose) or other medicines that suppress your immune system
  • You currently have another active cancer — though some exceptions apply, such as certain skin cancers fully removed, cancers fully cured with no sign of return for 3 or more years, or early-stage cancers fully treated by surgery (confirm with trial site)
  • You still have significant side effects from previous cancer treatments that have not resolved (with some exceptions for stable, mild, long-standing side effects — confirm with trial site)
  • You have a known allergy or sensitivity to biological medicines
  • You have a history of, or currently have, an autoimmune disease — though some exceptions apply, such as Type 1 diabetes or thyroid conditions managed with medication, or certain skin conditions not needing systemic treatment (confirm with trial site)
  • You have HIV infection — though in one part of the trial, people with well-controlled HIV on stable treatment may be eligible (confirm with trial site)
  • You have active or uncontrolled hepatitis B or C infection — though in one part of the trial, people with well-managed hepatitis B or C may be eligible (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 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: 908-992-6400

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
Sponsor
Daiichi Sankyo
Registry
ClinicalTrials.gov
Start date
14 November 2024
Est. completion
30 November 2028

Where this trial is recruiting

🇧🇪 Belgium 🇫🇷 France 🇳🇱 Netherlands 🇰🇷 South Korea 🇺🇸 United States

Primary endpoints

Part 1: Number of participants with Dose-Limiting Toxicities at each dose level of DS-2243a; Part 2: Number of participants with Treatment-Emergent Adverse Events; Part 2: Objective Response Rate

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