A Study of DXC006 in Patients With Advanced Solid Tumors and Hematologic Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHangzhou DAC Biotechnology Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- DXC006
Treatment groups
280 Participants
are divided into 1 treatment groupLocations
5Anhui Cancer Hospital230031, HefeiAnhui, China
Sun Yat-sen University Cancer Center510060, GuangzhouGuangdong, China
Hunan Cancer Hospital410013, ChangshaHunan, China
The First Affiliated Hospital of Nanchang University330006, NanchangJiangxi, China
Sponsors and collaborators
Hangzhou DAC Biotechnology Co., Ltd.
Lead sponsor
Source ClinicalTrials.gov