Actively Recruiting
An Open-label Dose Escalation and Cohort Expansion Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Efficacy 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating DXC006, a new drug, in patients with various advanced solid tumors and blood cancers, including small cell lung cancer, multiple myeloma, and neuroblastoma. This early-phase, open-label clinical trial aims to assess the safety, tolerability, maximum tolerated dose, dose-limiting toxicities, pharmacokinetic characteristics, preliminary anti-tumor activity, and immune response to DXC006 in these patients. Participants receive DXC006 intravenously every two weeks during both the dose escalation and dose expansion periods. The study includes an initial dose escalation phase to find the best dose and a cohort expansion phase to further evaluate safety and effectiveness at that dose. Patients who meet eligibility criteria may provide tumor tissue samples for laboratory analysis. Throughout the study, participants will undergo monitoring for adverse events and dose-limiting toxicities, with safety assessments continuing for about one year after the first infusion. Blood samples will be collected regularly to study drug levels and immune responses. Researchers will also measure tumor response, duration of response, progression-free survival, and overall survival. Participation duration varies by patient, with close follow-up to assess outcomes and safety.
CONDITIONS
Brief 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 and follows protocol requirements
- No gender restrictions
- Age 18 years or older
- Expected survival time of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Willingness to provide biopsy or tumor tissue samples for laboratory analysis
- Diagnosis of solid tumors or hematologic malignancies that have failed standard therapy, including small cell lung cancer, multiple myeloma, neuroblastoma
- For patients who had autologous stem cell transplant (ASCT): at least 100 days since transplant and no active infection
- Toxicity from prior cancer treatments recovered to Grade 1 or less (except alopecia), including peripheral neuropathy Grade 2 or less
- Adequate organ function as defined by blood counts, liver function, kidney function, coagulation, calcium levels, and heart function
- Agreement to use effective contraception from consent signing until 6 months after last dose
You will not qualify if you...
- Received plasmapheresis within 14 days before first dose
- Use of systemic corticosteroids over 10 mg prednisone equivalent daily for more than 3 days within 14 days before first dose (except short-term use for allergy prevention)
- Received systemic anti-myeloma or investigational drug therapy within 28 days or 5 half-lives before first dose
- Radiotherapy within 14 days before first dose
- Monoclonal antibody therapy within 30 days before first dose
- Autologous hematopoietic stem cell transplant within 100 days before first dose
- History of allogeneic stem cell or solid organ transplantation
- Prior same targeted therapy in early phase trials
- Symptomatic brain or meningeal metastases
- Symptomatic amyloidosis, active plasma cell leukemia, or active POEMS syndrome at screening
- Cardiovascular risks including prolonged QT interval, significant arrhythmias, recent heart attack or interventions, severe heart failure, uncontrolled severe hypertension
- Breathing difficulties requiring continuous oxygen or active pneumonia/interstitial lung disease
- History of other primary cancers except certain low-risk cured malignancies
- Severe unhealed wounds, fractures, or major surgery within 28 days before dosing
- Allergy to DXC006 components
- Active hepatitis B or C infection
- HIV positive or active syphilis or possible active tuberculosis
- Recent active bleeding or bleeding disorders
- Severe recent thrombotic events
- Positive pregnancy test or breastfeeding
- Active infections requiring treatment or uncontrolled fluid buildup
- Live attenuated vaccine within 28 days before first dose
- Other conditions deemed unsuitable by investigators or sponsor
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 - Up to 1 year or until disease progression or discontinuation
Participants receive DXC006 intravenously every two weeks during dose escalation and dose expansion periods to evaluate safety, tolerability, and preliminary anti-tumor activity.
Infusions every 2 weeks
Duration - Up to 1 year after treatment
Participants are monitored for safety, pharmacokinetics, and treatment response after completing therapy.
Regular visits for assessments during follow-up
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
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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