Phase 2 Bladder Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have given written, dated, and signed consent before any study procedures begin.
• People with a confirmed diagnosis of certain advanced or spread cancers that cannot be removed by surgery, depending on which part of the trial they are entering (see below).
• For kidney cancer (clear cell type): people who have already received at least one treatment with a type of drug called a tyrosine kinase inhibitor and at least one treatment with an immune checkpoint inhibitor for their advanced disease (at least two prior treatment lines total).
• For pancreatic ductal cancer: people who have already received at least one treatment containing platinum-based drugs and/or gemcitabine.
• For colorectal cancer: people who have already received specific chemotherapy combinations (FOLFIRINOX or FOLFOX/FOLFIRI) alongside anti-VEGF or anti-EGFR treatments.
• For colorectal and pancreatic cancers: people who have a fresh tissue sample available, or an existing stored tumour tissue sample (preferably from after the most recent treatment).
• For bladder cancer (urothelial cancer, Parts B and C only, outside the USA): people who have already received all available standard treatments for which they were eligible, including platinum-based chemotherapy, enfortumab vedotin, and pembrolizumab. Parts B and C are not conducted in the United States of America.
• People who have at least one tumour that has not been treated with radiation, visible on a CT or MRI scan taken within 4 weeks before the study scan.
• People whose disease can be measured using standard tumour response criteria (RECIST v1.1).
• For Part D only: people with a single kidney mass of 7 cm or smaller that is unclear on standard imaging, suspected to be clear cell kidney cancer, and for whom surgery or a diagnostic procedure is planned within 90 days of the study scan.
• For Part E only: people with confirmed advanced or spreading cancer of the bladder (including muscle-invasive type), head and neck, triple-negative breast cancer, squamous non-small cell lung cancer, or any other cancer confirmed to express a protein called carbonic anhydrase IX (excluding kidney, pancreatic, and colorectal cancers, and subject to sponsor agreement) — regardless of how many prior treatments they have received.
• For Part E: people who have at least one tumour not previously treated with radiation, visible on CT or MRI within 4 weeks before the study scan (if the scan is older than 4 weeks, the trial sponsor would need to be contacted to assess whether it is suitable).

Who may not be able to join:

• People who have had major surgery within 12 weeks before enrolling.
• People who are unable to lie still in a scanner with their arms positioned outside the chest and abdominal area for the length of the scan.
• People with a known allergy to the study drug (DPI-4452) or its ingredients, or to contrast agents used in imaging scans (applies to all parts).
• People with a blockage in the bladder outflow or urinary incontinence that cannot be managed (Parts A, B, and C).
• People who still have significant side effects from previous cancer treatments, surgery, or radiotherapy that have not recovered to a mild level, with some specific exceptions such as certain nerve-related symptoms or hair loss (Parts A, B, and C).
• People who have received another radioactive medicine within a period of time equal to 10 half-lives of that medicine before the study scan (Parts A, D, and E).
• People who have previously received any treatment specifically targeting the carbonic anhydrase IX protein for any cancer-related reason (Parts A, B, and C for oncological use; Part D and E within 3 months prior to the study scan).
• People who have received a radioactive medicine used as a cancer treatment within 6 months before the study scan (Parts B and C).
• People who have received any cancer treatment or participated in another investigational drug study within 5 half-lives or 4 weeks (whichever is shorter) before joining (Parts B and C).
• People with inflammatory bowel conditions such as Crohn's disease or ulcerative colitis (Parts B and C).
• For Part D: people who have another active cancer diagnosis, with certain exceptions — for example, cancers that were fully treated and have not returned within the past 2 years, or certain low-risk or non-active cancers such as treated skin cancers, low-grade prostate cancer, superficial bladder cancer, thyroid microcarcinoma, or other in-situ cancers (confirm with trial site).
• For Part D: people currently taking sulfonamide medications or blood-thinning medicines such as warfarin or acenocoumarol within 2 weeks (or 5 half-lives, whichever is longer) before the study scan.
• For Part E: people who have had radiation therapy covering more than 25% of the bone marrow, as assessed by the treating doctor.
• For Part E: people who have another active cancer diagnosis, with similar exceptions as described for Part D above.

Important: Always verify eligibility with the trial site directly before applying.