OncoMatch/Clinical Trials/NCT06926283
A Study of DXC008 in Patients With Prostate Cancer and Other Solid Tumors
Is NCT06926283 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies DXC008 for prostate cancer.
Treatment: DXC008 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Tumor Agnostic
Sarcoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard treatment
Patients with various solid tumors who have failed standard treatment
Cannot have received: XXX-targeted therapy
Exception: in Phase Ia clinical study only
Prior treatment with XXX-targeted therapy or topoisomerase inhibitors (in Phase Ia clinical study only)
Cannot have received: topoisomerase inhibitor
Exception: in Phase Ia clinical study only
Prior treatment with XXX-targeted therapy or topoisomerase inhibitors (in Phase Ia clinical study only)
Cannot have received: systemic antineoplastic therapy
Have received systemic antineoplastic therapy or investigational product treatment within 28 days or 5 half-lives (whichever is shorter) prior to the first dose
Cannot have received: radiotherapy
have received radiotherapy within 14 days prior to the first dose
Cannot have received: monoclonal antibody
Have received monoclonal antibody treatment within 30 days prior to the first dose
Cannot have received: plasmapheresis
Have undergone plasmapheresis within 14 days prior to the first dose
Cannot have received: systemic corticosteroid (prednisone)
Exception: short-term treatment for prevention of contrast media allergy may be enrolled
treated with prednisone at > 10 mg/day for > 3 consecutive days or equivalent dose of systemic corticosteroids or equivalent anti-inflammatory medication within 14 days prior to the first dose
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L (prior use of G-CSF is allowed, but G-CSF use is not allowed within 7 days prior to the screening laboratory tests). Platelet count ≥100×10^9/L (platelet transfusion is not allowed within 7 days before the screening laboratory tests). HGB ≥ 90 g/L (RBC transfusion or recombinant human erythropoietin use is allowed; RBC transfusion is not allowed within 7 days prior to the screening laboratory tests).
Kidney function
Ccr ≥ 60 mL/min; or creatinine ≤ 1.5 × ULN; urinalysis results show protein urine ≤ 1 +. For subjects with urine protein ≥2+ in urinalysis during the screening period, a 24-hour urine protein quantification should be performed, and those with 24-hour urine protein quantification ≤1 g can be enrolled.
Liver function
Total bilirubin (TBIL) ≤1.5×ULN, except for subjects with congenital bilirubinemia, such as Gilbert syndrome (direct bilirubin ≤1.5×ULN). AST and ALT ≤ 3.0 × ULN. For patients with liver metastases, both AST and ALT ≤5×ULN.
Cardiac function
LVEF≥50%. QTcF interval < 470 msec. No evidence of current clinically significant untreated arrhythmias, no history of myocardial infarct, acute coronary syndrome, coronary angioplasty or stent implantation, or bypass grafting within 6 months before screening. No Class III or IV heart failure (NYHA). Uncontrolled severe hypertension: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥ 100 mmHg excluded.
Organ function of the subjects must meet the following requirements: [see details above]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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