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New treatment option for Prostate Cancer
Official title A Study of DXC008 in Patients With Prostate Cancer and Other Solid Tumors
ClinicalTrials.gov ID: NCT06926283
What this study is testing
What is DXC008?
DXC008 is an investigational medicine, being studied as a potential treatment for prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- Within 14 days prior to the first dose: Have undergone plasmapheresis, treated with prednisone at \> 10 mg/day for \> 3 consecutive days or...
- Have received systemic antineoplastic therapy or investigational product treatment within 28 days or 5 half-lives (whichever is shorter) prior to the...
- Have received monoclonal antibody therapy for anti-tumor purposes within 30 days prior to the first dose.
- History of solid organ transplantation.
- Ewing sarcoma：Prior treatment with XXX-targeted therapy (in Phase Ia clinical study only) Other olid tumors：Prior treatment with XXX-targeted therapy...
- Presence of meningeal or brain metastases.
See the full eligibility criteria
Who can join
- 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.
- Prostate Cancer： Serum testosterone level during screening and prior to the first dose of investigational product: ≤50 ng/dL (≤1.73 nmol/L).
- Prostate Cancer is divided into two cohorts： 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...
- Toxicities from prior antitumor therapy must have recovered to Grade ≤ 1 as defined in the NCI-CTCAE v5.0 (except alopecia), or Grade 2 as defined by NCI-CTCAE v5.0, except for toxicity not constituting a safety risk by...
- Organ function of the people must meet the following requirements: Hematology:
- 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). Liver function:
- Total bilirubin (TBIL) ≤1.5×ULN, except for people 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. Renal function: Ccr ≥ 60 mL/min; or creatinine ≤ 1.5 × ULN; urinalysis results show protein urine ≤ 1 +. For people with urine protein...
- INR≤1.5.
- APTT or PT ≤ 1.5 × ULN. LVEF≥50%.
- people and their spouses agree to use effective instrumental or pharmacologic contraception (excluding safe period contraception) from the time of ICF signing until 6 months after the last dose of investigational...
What rules you out
- 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...
- 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...
- Have received monoclonal antibody therapy for anti-tumor purposes within 30 days prior to the first dose.
- History of solid organ transplantation.
- Ewing sarcoma：Prior treatment with XXX-targeted therapy (in Phase Ia clinical study only) Other olid tumors：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]).
- Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities including second-degree (Mobitz Type II) or third-degree atrioventricular (AV) block.
- Within 6 months before screening, history of myocardial infarct, acute coronary syndrome (including unstable angina pectoris), coronary angioplasty or stent implantation, or bypass grafting.
- Class III or IV heart failure - as defined by the New York Heart Association Functional Classification.
- Uncontrolled severe hypertension: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥ 100 mmHg.
- Have dyspnea or any current condition that needs continuous oxygen therapy, or current active pneumonia or interstitial lung diseases (except mild cases as judged by the investigator).
- History of other primary malignancies, except for the following: malignancies that have been cured and have a very low risk of recurrence within 5 years, such as basal cell carcinoma and squamous cell carcinoma of the...
- Have severe unhealed wound, ulceration or bone fracture, or have received major surgery within 28 days prior to administration or expected major surgery during the clinical study.
- Prior history of allergy to any component or excipient of DXC008.
- Active hepatitis B with HBV-DNA greater than central upper limit of normal or greater than 1000 copies/mL, active hepatitis C (Hepatitis C virus antibody positive with HCV RNA greater than lower limit of detection...
- Known to be seropositive for the HIV; have active syphilis (only patients with a positive syphilis antibody are eligible for enrollment in the study), possible presence of active tuberculosis (chest imaging within 3...
- Patients with active bleeding within 30 days before screening, or, judged by the investigator, to be at risk of massive digestive tract hemorrhage, hemoptysis, etc.; or with hereditary bleeding tendency or coagulation...
- Have experienced serious arterial/venous thrombosis events within 6 months prior to the first dose, such as cerebrovascular accident (including transient cerebral ischemic attack), deep venous thrombosis, pulmonary...
- Female people with positive serum pregnancy test or who are breastfeeding.
- Those with active infection requiring drug intervention (CTCAE ≥ Grade 2) within 2 weeks prior to the first dose of study treatment, uncontrollable pleural effusion, ascites, pericardial effusion requiring repeated...
- Have received vaccination with live attenuated vaccine within 28 days prior to the first dose or planned to receive such vaccination during the study period.
- Patients with other conditions judged by the investigator that may have adverse effect on the patient's participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, China
- Hangzhou, Zhejiang, China
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Hunan, China; Hangzhou, Zhejiang, China; Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.