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
This trial does not accept healthy volunteersQualifiers
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 therapy for anti-tumor purposes within 30 days prior to the first dose.
History of solid organ transplantation.
Trial design
Design model
Single group
Treatments tested in this trial
DXC008
DrugCohort A: Once every 2 weeks (Q2W) with a cycle length of 14 days. Cohort B: Once every 3 weeks (Q3W) with a cycle length of 21 days.
Treatment groups
110 Participants
are divided into 1 treatment groupGroup A: DXC008Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.
Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated.
Time frame
28 days2
Number of participants with adverse events (AEs).
The adverse events will be evaluated in accordance with CTCAE v5.0. The investigator shall assess the relationship between the events and investigational product.
Time frame
After first infusion of study drug, Through study completion an average of 1 year.Secondary outcomes
1
Maximum observed serum or plasma concentration (Cmax).
One of the pharmacokinetics parameters for DXC008 investigator shall assess the relationship between the events and investigational product.
Time frame
Through study completion an average of 1 year.2
Maximum serum drug time (Tmax).
One of the pharmacokinetics parameters for DXC008.
Time frame
Through study completion an average of 1 year.3
Apparent volume of distribution(Vd).
One of the pharmacokinetics parameters for DXC008.
Time frame
Through study completion an average of 1 year.4
Measurement of objective response rate (ORR) per RECIST 1.1.
Percentage of subjects achieving complete response (CR) or partial response (PR).
Time frame
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov