Actively Recruiting
A Phase I, Open-Label, Multicenter, First-in-Human, Dose Escalation and Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profiles and Preliminary Efficacy of DXC008 in Patients With Prostate Cancer and Other Solid Tumors (Such as Ewing Sarcoma)
Led by Hangzhou DAC Biotechnology Co., Ltd. · Updated on 2026-04-24
110
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating DXC008 in patients with prostate cancer and other solid tumors, including Ewing sarcoma, in a phase I, open-label, first-in-human clinical study. This study aims to assess the safety, tolerability, maximum tolerated dose, dose-limiting toxicities, recommended phase 2 dose, pharmacokinetics, preliminary anti-tumor activity, and immunogenicity of DXC008. The trial is sponsored by Hangzhou DAC Biotechnology Co., Ltd. Participants receive DXC008 either once every 2 weeks (Cohort A) or once every 3 weeks (Cohort B), with cycle lengths of 14 and 21 days respectively. The study includes dose escalation and expansion phases to evaluate the drug's effects and safety. Treatment continues under close monitoring for adverse events and dose-limiting toxicities within 28 days after dosing. During the study, participants undergo various assessments including measurement of drug concentration in blood, evaluation of tumor response using RECIST 1.1 and PCWG3 criteria, and monitoring for adverse events over about one year. Organ function tests and imaging scans are used to assess eligibility and track disease status. Participants' safety is closely observed throughout the trial, which may last up to a year or more depending on individual progress.
CONDITIONS
Brief Title
A Study of DXC008 in Patients With Prostate Cancer and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteers who sign informed consent and follow study requirements
- Male or female participants
- 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 treatments, including progressive metastatic castration-resistant prostate cancer
- Serum testosterone level at or below 50 ng/dL during screening and before first dose
- At least one measurable lesion (Cohort 1) or metastatic lesion on imaging (Cohort 2)
- Recovery from prior treatment toxicities to Grade 1 or 2 as specified
- Adequate organ function including blood counts, liver, kidney, and coagulation parameters
- Agreement to use effective contraception during and for 6 months after treatment
You will not qualify if you...
- Recent plasmapheresis or high-dose corticosteroid treatment within 14 days prior to first dose
- Recent systemic anticancer therapy or radiotherapy within specified timeframes
- Recent monoclonal antibody treatment within 30 days
- History of solid organ transplantation
- Prior treatment with certain targeted therapies or topoisomerase inhibitors (for Phase Ia only)
- Presence of meningeal or brain metastases
- Cardiovascular risks including prolonged QT interval, significant arrhythmias, recent heart events, severe heart failure, or uncontrolled hypertension
- Current respiratory issues requiring oxygen or active lung infections
- History of other primary cancers except certain cured types
- Severe unhealed wounds or recent major surgery
- Allergy to DXC008 components
- Active hepatitis B or C infections
- HIV positive or active syphilis or tuberculosis
- Recent active bleeding or bleeding disorders
- Recent serious thrombosis events
- Pregnancy or breastfeeding in female participants
- Active infections requiring treatment within 2 weeks prior to first dose
- Recent live vaccine administration or planned vaccination during study
- Other medical conditions that may interfere with participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 14-day or 21-day cycles until disease progression or discontinuation
Participants receive DXC008 drug treatment through intravenous infusion on either a once every 2 weeks schedule or a once every 3 weeks schedule depending on their cohort assignment.
1 infusion visit every 2 or 3 weeks depending on cohort
Duration - Up to 1 year after first dose
Participants are monitored for safety, tolerability, pharmacokinetics, and preliminary efficacy through approximately 1 year after treatment initiation.
Visits scheduled periodically during follow-up
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
Z
Zhisong He
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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