Actively Recruiting
A Study of DXC014 in Patients With Advanced Solid Tumors.
Led by Hangzhou DAC Biotechnology Co., Ltd. · Updated on 2026-04-24
150
Participants Needed
3
Research Sites
241 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 DXC014 in patients with Advanced Solid Tumors.
CONDITIONS
Official Title
A Study of DXC014 in Patients With Advanced Solid Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form and comply with protocol requirements
- Male or female participants
- Age 18 years or older (up to 75 years for solid tumor patients; prostate cancer patients age 18 and older)
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least one measurable lesion as defined by RECIST v1.1 for prostate cancer or other solid tumors
- Recovery from toxicities of prior anti-tumor therapy to Grade 1 or less (Grade 2 allowed if judged safe by investigator)
- Adequate organ function based on blood counts, liver, kidney, coagulation, and heart function tests
- Participants and their partners agree to use effective contraception from consent until 6 months after last dose
You will not qualify if you...
- Plasmapheresis or systemic corticosteroids >10 mg/day prednisone (or equivalent) for more than 3 consecutive days within 14 days before first dose
- Systemic anti-tumor therapy or investigational drugs within 28 days or 5 half-lives before first dose; recent palliative radiotherapy or certain herbal medicines
- History of solid organ transplantation
- Active or unstable brain or spinal metastases except stable treated brain metastases without symptoms
- Cardiovascular risks including prolonged QTcF interval, significant arrhythmias, recent heart attack or procedures, severe heart failure, or uncontrolled high blood pressure
- Uncontrolled diabetes mellitus
- Current lung diseases or conditions interfering with pulmonary toxicity management
- Other malignancies within past 5 years except certain treated cancers with long disease-free survival
- Severe unhealed wounds, recent major surgery, or planned major surgery during study
- Allergy to DXC014 components
- Active hepatitis B or C infection
- Positive HIV or active syphilis or suspected active tuberculosis
- Active bleeding or bleeding disorders
- Recent severe thrombotic events
- Pregnant or breastfeeding females
- Active infection requiring systemic treatment or uncontrolled effusions
- Recent live attenuated vaccination or planned vaccination during study
- Any other condition affecting study participation per investigator judgment
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
Not Yet Recruiting
2
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Not Yet Recruiting
3
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
P
Pengyu Shi
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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