A Study of DXC008 in Patients With Prostate Cancer and Other Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHangzhou DAC Biotechnology Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- DXC008
Treatment groups
110 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov