Actively Recruiting
A Study of DXC008 in Patients With Prostate Cancer and Other Solid Tumors
Led by Hangzhou DAC Biotechnology Co., Ltd. · Updated on 2026-04-24
110
Participants Needed
3
Research Sites
254 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of DXC008 in Patients With Prostate Cancer and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent and follow protocol requirements
- Male or female
- Age between 18 and 75 years
- Expected life expectancy of at least 6 months
- ECOG performance status score between 0 and 2
- Patients with solid tumors who have failed standard treatment, including progressive metastatic castration-resistant prostate cancer
- Serum testosterone level 50 ng/dL (1.73 nmol/L) or lower at screening and before first dose
- Cohort 1: at least one measurable lesion by RECIST v1.1; Cohort 2: at least one metastatic lesion on CT/MRI or bone scan at baseline
- Toxicities from prior antitumor therapy recovered to Grade 1 or lower (except alopecia), or Grade 2 if not a safety risk
- Organ function meeting specified hematology, liver, renal, and coagulation criteria
- Subjects and their spouses agree to use effective contraception from informed consent signing until 6 months after last dose
You will not qualify if you...
- Plasmapheresis, prednisone >10 mg/day for >3 consecutive days, or equivalent systemic corticosteroids within 14 days prior to first dose (except short-term for contrast allergy prevention)
- Systemic antineoplastic therapy or investigational product within 28 days or 5 half-lives prior to first dose; radiotherapy within 14 days
- Monoclonal antibody treatment within 30 days prior to first dose
- History of solid organ transplantation
- Prior treatment with XXX-targeted therapy or topoisomerase inhibitors (Phase Ia only)
- Presence of meningeal or brain metastases
- Cardiovascular risk including QTcF ≥470 msec, untreated significant arrhythmias, recent myocardial infarction or acute coronary syndrome within 6 months, NYHA Class III/IV heart failure, uncontrolled severe hypertension
- Dyspnea or conditions requiring continuous oxygen therapy, active pneumonia or interstitial lung disease (except mild)
- History of other primary malignancies except certain cured low-risk cancers
- Severe unhealed wounds, ulcers, bone fractures, or major surgery within 28 days prior or planned during study
- Allergy to DXC008 components
- Active hepatitis B or C infections
- HIV seropositive, active syphilis, or possible active tuberculosis
- Active bleeding or bleeding disorders within 30 days prior to screening
- Serious arterial/venous thrombosis within 6 months prior to first dose
- Female subjects pregnant or breastfeeding
- Active infection requiring treatment within 2 weeks prior to first dose
- Live attenuated vaccine within 28 days prior or planned during study
- Other conditions judged by investigator to impair participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
2
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
3
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Actively Recruiting
Research Team
Z
Zhisong He, Doctor
CONTACT
Z
Zhisong He
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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