Actively Recruiting
A Study of DXC006 in Patients With Advanced Solid Tumors and Hematologic Malignancies
Led by Hangzhou DAC Biotechnology Co., Ltd. · Updated on 2025-01-28
110
Participants Needed
1
Research Sites
101 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 DXC006 in patients with a variety of solid tumors, including small cell lung cancer, multiple myeloma, and neuroblastoma, and hematological malignancies.
CONDITIONS
Official Title
A Study of DXC006 in Patients With Advanced Solid Tumors and Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has voluntarily signed informed consent.
- No gender restriction; all genders allowed.
- Age 18 years or older.
- Expected survival of at least 3 months.
- ECOG performance status score between 0 and 2.
- Ability to provide biopsy or tumor tissue samples for target protein testing.
- Diagnosed with solid tumors or hematologic cancers including small cell lung cancer, multiple myeloma, or neuroblastoma, with prior standard therapy failure.
- If received autologous stem cell transplant, it must be more than 100 days before starting study treatment and no active infection present.
- Recovery from previous cancer treatment side effects to Grade 1 or less, except hair loss; peripheral neuropathy must be Grade 2 or less.
- Adequate organ function based on blood counts, liver, kidney, coagulation, corrected calcium levels, and heart function (LVEF ≥ 50%).
- Agreement to use effective contraception from signing consent until 6 months after last dose.
You will not qualify if you...
- Received plasmapheresis within 14 days before first dose.
- Taken more than 10 mg prednisone or equivalent corticosteroids daily for more than 3 consecutive days recently (except short-term use for allergy prevention).
- Received systemic anti-myeloma or investigational therapy within 28 days or 5 half-lives before first dose.
- Received radiotherapy within 14 days before first dose.
- Received monoclonal antibody therapy within 30 days before first dose.
- Had autologous stem cell transplant within 100 days before first dose.
- History of allogeneic stem cell transplant or solid organ transplant.
- Prior use of the same targeted therapy in earlier phase Ia clinical trials.
- Symptomatic brain or meningeal metastases.
- Symptomatic amyloidosis, active plasma cell leukemia, or active POEMS syndrome.
- Cardiovascular risks including prolonged QTc interval, significant arrhythmias, recent heart attack or procedures, severe heart failure, or uncontrolled high blood pressure.
- Breathing difficulties requiring oxygen or active lung infections except mild cases.
- History of other primary cancers except certain cured low-risk types.
- Severe untreated wounds, fractures, or recent major surgery.
- Allergy to DXC006 components.
- Active hepatitis B or C infections.
- HIV positive or active tuberculosis.
- Recent or risk of severe bleeding or clotting disorders.
- Recent severe thrombotic events.
- Pregnant or breastfeeding women.
- Active infections needing treatment or uncontrolled fluid buildup.
- Received live vaccines within 28 days before first dose.
- Other conditions deemed unsuitable by investigators or sponsors.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510050
Actively Recruiting
Research Team
P
Prof. Zhang Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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