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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
DXC006
DrugDose escalation period: DXC006 is administered intravenously every two weeks (Q2W) at the dose corresponding to the enrolled dose cohort. Dose expansion period: DXC006 is administered intravenously Q2W at the corresponding dose.
Treatment groups
280 Participants
are divided into 1 treatment groupGroup A: ExperimentalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.
Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated.
Time frame
28 days2
Number of participants with adverse events (AEs)
The adverse events will be evaluated in accordance with CTCAE v5.0. The investigator shall assess the relationship between the events and investigational product.
Time frame
After first infusion of study drug, Through study completion an average of 1 yearSecondary outcomes
1
Maximum observed serum or plasma concentration (Cmax)
One of the pharmacokinetics parameters for DXC006investigator shall assess the relationship between the events and investigational product.
Time frame
Through study completion an average of 1 year2
Maximum serum drug time（Tmax）
One of the pharmacokinetics parameters for DXC006.
Time frame
Through study completion an average of 1 year3
Apparent volume of distribution(Vd)
One of the pharmacokinetics parameters for DXC006.
Time frame
Through study completion an average of 1 year4
Volume of distribution at steady state (Vss)
One of the pharmacokinetics parameters for DXC006.
Time frame
Through study completion an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov