A Study of DXC008 in Patients With Prostate Cancer and Other Solid Tumors (NCT06926283) | Clinical Trial Compass
RecruitingPhase 1
A Study of DXC008 in Patients With Prostate Cancer and Other Solid Tumors
China110 participantsStarted 2025-05-15
Plain-language summary
This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, MTD, DLT, RP2D, the PK characteristics, preliminary anti-tumor activity, the immunogenicity of DXC008 in patients with prostate cancer and other solid tumors such as Ewing sarcoma.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Those who voluntarily sign the ICF and follow the protocol requirements.
. Male or female.
. Age: ≥ 18 years and ≤ 75 years.
. Expected life expectancy ≥ 6 months.
. ECOG performance status score: 0-2.
. Patients with various solid tumors who have failed standard treatment, including but not limited to progressive mCRPC.
. Serum testosterone level during screening and prior to the first dose of investigational product: ≤50 ng/dL (≤1.73 nmol/L).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.
Timeframe: 28 days
2
Number of participants with adverse events (AEs).
Timeframe: After first infusion of study drug, Through study completion an average of 1 year.
. Cohort 1: at least one measurable lesion as defined by RECIST v1.1. Cohort 2: at least one metastatic lesion on CT/MRI, or bone scan imaging at baseline. Patients are assigned to the appropriate cohort as assessed by the investigator, the study procedures in Cohort 1 and Cohort 2 may be performed in parallel and simultaneously, it is not necessary to wait until all procedures in either cohort have been completed before initiating procedures in the other cohort.
Exclusion criteria
. Within 14 days prior to the first dose: Have undergone plasmapheresis, treated with prednisone at \> 10 mg/day for \> 3 consecutive days or equivalent dose of systemic corticosteroids or equivalent anti-inflammatory medication (Those who have received short-term treatment with such medications for the prevention of contrast media allergy may be enrolled).
. Have received systemic antineoplastic therapy or investigational product treatment within 28 days or 5 half-lives (whichever is shorter) prior to the first dose, have received radiotherapy within 14 days prior to the first dose.
. Have received monoclonal antibody treatment within 30 days prior to the first dose.
. History of solid organ transplantation.
. Prior treatment with XXX-targeted therapy or topoisomerase inhibitors (in Phase Ia clinical study only).
. Presence of meningeal or brain metastases.
. Evidence of cardiovascular risk, including any of the following:
. QTcF interval ≥ 470 msec (QT interval must be corrected for heart rate using the Fridericia formula \[QTcF\]).