Phase 1 Melanoma 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 are willing to sign a consent form and follow the study requirements
• People of any sex (male or female)
• For most solid tumour patients: people aged 18 to 75 years; for prostate cancer patients: people aged 18 or older with no upper age limit
• People whose doctors estimate they are likely to live at least 3 more months
• People who are generally able to care for themselves and carry out light activity, as measured by a standard health performance scale (ECOG score of 0 or 1)
• People diagnosed with prostate cancer or another type of solid tumour
• For prostate cancer (two separate groups): one group requires at least one tumour that can be measured on a scan using standard criteria (RECIST v1.1); the other group requires at least one confirmed spread (metastasis) visible on a CT scan, MRI, or bone scan
• For other solid tumours: at least one tumour that can be measured on a scan using standard criteria (RECIST v1.1)
• People whose side effects from past cancer treatments have largely resolved (to a low level), with some exceptions allowed if the trial doctor judges there is no safety risk
• People whose blood, liver, kidney, and heart function results fall within the ranges required by the trial (confirm specific values with the trial site)
• People (and their partners) who agree to use reliable contraception from the time of signing consent until 6 months after the last dose of the study drug (the rhythm/calendar method is not accepted)

Who may not be able to join:

• People who had a plasma exchange procedure, or who took higher-dose steroid or anti-inflammatory medicines for more than 3 days in a row, within the 14 days before their first dose
• People who received other cancer treatments or experimental drugs within 28 days (or 5 half-lives, whichever is shorter) before their first dose, palliative radiation within 14 days, or certain herbal or traditional medicines approved for anti-cancer use within 1 week before their first dose
• People who have had a solid organ transplant (such as a kidney, liver, or heart transplant)
• Prostate cancer patients with cancer that has spread to the lining of the brain or the brain itself; for other solid tumours, people with active brain or spinal cord involvement, unless their brain metastases are stable and symptom-free under specific conditions (confirm details with the trial site)
• People with certain heart or cardiovascular concerns, including a prolonged heart rhythm interval on an ECG, certain untreated irregular heartbeats, a heart attack or major heart procedure in the past 6 months, severe heart failure, or uncontrolled high blood pressure (systolic at or above 160 mmHg or diastolic at or above 100 mmHg)
• People with uncontrolled diabetes
• People with current lung conditions such as interstitial lung disease, pulmonary fibrosis, serious lung damage from radiation, or severely reduced lung function
• People who have had another cancer diagnosis within the past 5 years, with limited exceptions for certain early-stage or fully treated cancers (confirm details with the trial site)
• People with serious unhealed wounds, ulcers, or broken bones; people who had major surgery within 28 days before starting the trial or who expect to have major surgery during the study
• People with a known allergy to any ingredient in the study drug DXC014
• People with active hepatitis B or active hepatitis C infections (as defined by specific blood test results)
• People known to be HIV positive; people with active syphilis requiring treatment; people with suspected active tuberculosis based on recent chest imaging
• People who have had active bleeding within 30 days before screening, are considered at risk of serious bleeding, have an inherited bleeding disorder, or have bleeding symptoms needing medical treatment
• People who have had a serious blood clot event (such as a stroke, blood clot in the leg, or pulmonary embolism) within the 6 months before starting the trial
• Women who are pregnant or breastfeeding
• People with an active infection requiring systemic medication within 2 weeks before the first dose, or with uncontrolled fluid build-up around the lungs, abdomen, or heart that requires repeated draining
• People who received a live vaccine within 28 days before the first dose or who plan to receive one during the study
• People with any other condition that the trial doctor or study sponsor believes could affect safe participation in the study

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