A Study of DXC006 in Patients With Advanced Solid Tumors and Hematologic Malignancies (NCT06224855) | Clinical Trial Compass
RecruitingPhase 1
A Study of DXC006 in Patients With Advanced Solid Tumors and Hematologic Malignancies
China280 participantsStarted 2024-01-24
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The patient voluntarily signed the informed consent form and followed the protocol requirements.
. Gender is not limited.
. Age ≥ 18 years old.
. Expected survival time ≥ 3 months.
. The Eastern Cooperative Oncology Group (ECOG) score 0-2.
. Subjects may provide biopsy or archival tumor tissue samples for the central laboratory to confirm expression levels of Target protein.
. Patients with solid tumors or hematologic tumors who have failed standard therapy, including small cell lung cancer, multiple myeloma, neuroblastoma, etc..
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.
Timeframe: 28 days
2
Number of participants with adverse events (AEs)
Timeframe: After first infusion of study drug, Through study completion an average of 1 year
. Patients who have received ASCT treatment must meet the following conditions:
Exclusion criteria
. Within 14 days before the first dose: received plasmapheresis; Treatment with \> 10 mg of prednisone or equivalent doses of systemic corticosteroids per day for more than 3 consecutive days (short-term use for the prevention of contrast allergy can be enrolled).
. Patients have received systemic anti-myeloma therapy or investigational drug therapy within 28 days or 5 half-lives (whichever is shorter) prior to the first dose; Radiotherapy within 14 days prior to the first dose.
. Patients have received monoclonal antibody therapy within 30 days before the first dose.
. Patients have received autologous hematopoietic stem cell transplantation within 100 days before the first dose.
. Patients who have undergone allogeneic hematopoietic stem cell transplantation (HSCT) or have a history of solid organ transplantation.
. Patients have received the same targeted therapy in the past (limited to phase Ia clinical trials).
. Patient has symptomatic brain metastases or meningeal metastases.
. The patient had symptomatic amyloidosis, active plasma cell leukemia, and active POEMS syndrome at the time of screening.