Phase 1 Bladder Cancer Trial, Recruiting NCT05614739 Sponsor: Eli Lilly and Company Condition: Bladder Cancer
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Phase 1 Bladder Cancer Trial, Recruiting

NCT05614739
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:

  • People who have a solid tumour cancer with a specific change (called an FGFR3 pathway alteration) found through testing of a tumour or blood sample, where that change is considered meaningful for treatment
  • Depending on which group (cohort) a person is assigned to, eligibility may require a diagnosis of bladder or urinary tract cancer (called urothelial cancer) that has spread locally or to other parts of the body, with or without a specific FGFR3 genetic change
  • People in one group (Cohort C1) must have a solid tumour that is not urothelial cancer, that has spread locally or to other parts of the body, and has a qualifying FGFR3 genetic change
  • Having a tumour that can be measured by scans is required for most groups; some groups also accept tumours that cannot be measured by standard criteria
  • People who have a tumour tissue sample available for testing (those without enough tissue may still be considered after review by the trial team)
  • People who are well enough to carry out daily activities — this is measured using a standard scale, with stricter fitness requirements for some groups than others
  • People who have already received certain prior cancer treatments, with the number of prior treatments required varying depending on the group assigned (confirm with trial site)
  • People in one group (Cohort B5) who have not yet received any systemic treatment for locally advanced or metastatic urothelial cancer
  • Prior treatment with a type of drug called an FGFR inhibitor is allowed for some groups, required for others (Cohorts B1 and B4 require prior treatment with a drug called erdafitinib), and not permitted for others (Cohorts B2, B5, and C1)

Who may not be able to join:

  • People whose cancer started in the brain or spinal cord (primary central nervous system cancer)
  • People who have cancer that has spread to the brain or spinal cord and has not been treated or is not well controlled
  • People with active eye conditions affecting the cornea or retina (those with mild eye conditions that are not causing symptoms may still be considered)
  • People who still have serious side effects from previous cancer treatments that have not resolved
  • People with significant heart or cardiovascular problems
  • People with a particular irregularity in their heart's electrical activity (an abnormal heart rhythm measurement called a prolonged QTcF interval)
  • People with an active, uncontrolled infection or other serious ongoing medical conditions
  • People who are currently pregnant, breastfeeding, or planning to breastfeed during the study or within 6 months of the last dose of the study treatment (people who have already stopped breastfeeding may be considered)

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 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

Principal Investigator: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Phone: 1-317-615-4559

Australian sites

St Vincent's Hospital, Darlinghurst,
Calvary Mater Newcastle, Hunter Region, NSW,
GenesisCare North Shore, St Leonards,
Macquarie University, Sydney,

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
12 January 2023
Est. completion
1 June 2027

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇨🇳 China 🇫🇷 France 🇩🇪 Germany 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇳🇴 Norway 🇰🇷 South Korea 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Phase 1a: To determine the recommended dose of LOXO-435: Safety, number of participants with dose-limiting toxicities (DLTs); Phase 1b: To evaluate the preliminary antitumor activity of LOXO-435: Overall response rate (ORR); Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

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