Phase 2 Prostate 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 aged 18 or older at the time of signing the consent form
• People who are able to read, understand, and sign a consent form, and who are willing and able to follow all study procedures
• Women who are at least 2 years past menopause, or who have had a surgical procedure making pregnancy impossible (documented at least 6 months before the study begins), or women who could become pregnant but who are not breastfeeding, have a negative pregnancy test within 72 hours before the first dose, and agree to use two forms of contraception (one of which must be a barrier method) during the study and for 6 months after the last dose
• Men whose partners could become pregnant must agree to use two forms of contraception (one of which must be a barrier method) during the study and for 6 months after the last dose
• People with a confirmed diagnosis of a solid tumour cancer for which no standard treatments are available, or for which standard treatments are not an option or have been declined — specific cancer types vary by phase and study group (confirm with trial site)
• For the early dose-testing phase (Phase 1a): people with one of these cancer types — advanced prostate cancer (mCRPC), breast cancer (certain subtypes), colorectal cancer, non-small cell lung cancer, or pancreatic cancer
• For the expansion phase (Phase 1b), people with one of the following: advanced prostate cancer that has stopped responding to standard treatment and has been previously treated with at least one specific hormone-blocking therapy; advanced non-small cell lung cancer that has stopped responding to standard treatment; advanced metastatic breast cancer (certain subtypes) that has stopped responding to standard treatment; or advanced metastatic colorectal or pancreatic cancer that has stopped responding to standard treatment
• People who can provide a stored tumour tissue sample if one is available (a new biopsy is not required for eligibility purposes; those without a sample may still be considered with approval from the medical monitor)
• People whose cancer can be measured or assessed on scans — measurable disease on scans is required for the expansion and later phases
• People with a general health and activity level rated at 0, 1, or 2 on a standard scale used by doctors to assess how cancer affects daily functioning (confirm with trial site)
• People with a life expectancy of at least 3 months
• People whose blood counts, kidney function, and liver function meet the specific levels required by the trial (confirm with trial site for exact values)

Who may not be able to join:

• People who have had another cancer diagnosis within the past 3 years, or who still show signs of a previously diagnosed cancer — exceptions may apply for certain cured or low-risk cancers (confirm with trial site)
• People with a known or suspected allergy or sensitivity to any ingredient in the study drug MBRC-201
• People with currently active cancer spread to the brain or the lining of the brain — people with a past history of this may be considered if the condition has been treated and is stable, with no steroid treatment for related symptoms in the past 2 weeks
• People who have had an uncontrolled viral, bacterial, or fungal infection in the 2 weeks before the first dose, unless considered minor by the treating doctor
• People with active or symptomatic hepatitis, including active hepatitis C infection or those who have received hepatitis C antiviral treatment in the past 6 months
• People living with HIV who also have certain additional conditions, including a recent AIDS-defining illness, a recent change in HIV medication combined with a high viral load, HIV medication that may interact with the study drug, or a low immune cell (CD4) count (confirm with trial site for specific thresholds)
• People who have experienced a blood clot or bleeding disorder in the 14 days before the first dose
• People who have had a stroke, a mini-stroke (transient ischaemic attack), unstable chest pain, a heart attack, or significant heart failure symptoms within the 6 months before the first dose
• People with certain abnormal heart rhythm readings on an ECG, or who have specific risk factors for a dangerous irregular heartbeat (confirm with trial site)
• People with uncontrolled inflammatory bowel disease
• People with a history of lung inflammation (ILD/pneumonitis) that required steroid treatment, or who have active or suspected lung inflammation at the time of screening
• People with an uncontrolled autoimmune disease or condition
• People with active eye surface disease at the time of screening, such as corneal ulcers, certain types of eye inflammation, or corneal damage — cataracts alone are not an exclusion
• People who have received any cancer treatment within 14 days before the first dose, including chemotherapy, immunotherapy, targeted therapy, radiation, or other anti-cancer agents (certain hormone therapies for prostate or breast cancer may be exempt — confirm with trial site)
• People who have taken another experimental (investigational) drug within 14 days before the first dose
• For the expansion and later phases: people who have previously been treated with certain antibody-drug conjugates (ADCs) that carry a specific type of chemotherapy payload, including drugs such as trastuzumab deruxtecan (Enhertu), datopotamab deruxtecan (Datroway), or sacituzumab govitecan (Trodelvy)
• People currently taking any medications that are not permitted during this trial (confirm with trial site for the full list)
• People who have had major surgery within 28 days before the first dose
• People who have not recovered from side effects of previous cancer treatments, where those side effects are still rated above a minor level (with the exception of hair loss)
• People with a medical, psychiatric, or other condition that would affect their ability to give informed consent or follow study procedures
• People whose situation, in the opinion of the trial investigator or sponsor, could put them at significant risk, affect the study results, or make participation difficult
• People with other serious medical conditions that would make it difficult to receive or tolerate the planned treatment

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