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 range18 Years – 75 Years
SexALL
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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).
✓. 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.
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.