A Study of DM001 in Patients With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorXadcera Biopharmaceutical (Suzhou) Co., Ltd.
About this trial
The goal of this clinical trial is to find out about the safety, efficacy, and tolerability of DM001 for patients with the advanced solid tumors. DM001 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors.
Participants will have up to 17 visits during the study.There will be up to a 4-week Screening Period followed by a treatment period that will be divided into 3-week cycles/ Participants will have 5 study visits during Cycle 1, 3 visits during Cycles 2 and 3, and 1 visit during subsequent cycles. Participants will have an End of Treatment visit 21 days (+ 7 days) after last dose of study drug and then a follow-up visit 30 days (± 7 days) after the End of Treatment visit.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects must have the ability to understand and willingness to sign a written informed consent document.
Subjects who have pathologically or cytologically confirmed documented metastatic/advanced breast cancer, EGFRmut or EGFRwt NSCLC, gastric cancer, gastroesophageal cancer or CRC, and have progressed on standard therapy, or intolerant to standard therapy, or no standard therapy accessible to the subjects due to any reason.
Subjects must be ≥18 years of age at the time of signing the informed consent form.
Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Disqualifiers
Subjects have another active invasive malignancy within 5 years.
Current or history of a hematologic malignancy.
Primary central nervous system (CNS) malignancies or CNS metastases. Individuals with brain metastases can be enrolled only if treated, nonprogressive brain metastases and off high-dose steroids (>20 mg prednisone or equivalent) for at least 4 weeks.
Individuals with Gilbert's disease with ≥3 × ULN.
Trial design
Design model
Single group
Treatments tested in this trial
DM001
DrugSubjects may continue to receive DM001 (with an increased dose that has been assessed as safe in the dose-escalation period) once every 3 weeks (Q3W) for a total of 6 cycles at the discretion of the investigators, until unacceptable toxicity, progressive disease (PD), or withdrawal of consent.
Treatment groups
128 Participants
are divided into 1 treatment groupGroup A: DM001 administrated to subjects with advanced or metastatic solid tumorsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-limiting Toxicities (DLTs) of DM001
Incidence of DLTs of DM001 will be determined. A dose-limiting toxicity (DLT) was defined as grade 3 neurological toxicities (e.g. chemical meningitis) or other grade 4 toxicity.
Time frame
12 months2
Maximum tolerated dose (MTD) for DM001
The MTD of DM001 will be determined. The MTD was defined as the dose where 0/3 or 1/6 patients experienced a DLT with at least two patients encountering DLT at the higher dose.
Time frame
12 monthsSecondary outcomes
1
Area under the plasma concentration-time curve (AUC(0-inf), ng*h/mL)
Area under the plasma concentration-time curve from time zero extrapolated to infinity, calculated by linear up/log down trapezoidal summation.
Time frame
12 months2
Maximum (peak) plasma concentration (Cmax, ng/mL)
Maximum concentration, obtained directly from the observed concentration versus time data.
Time frame
12 months3
Time to maximum (peak) concentration (Tmax, h)
Time to Cmax
Time frame
12 months4
Trough concentration (Ctrough, ng/mL)
The lowest plasma concentration reached before the next dose.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov