Phase I Clinical Study of MBS301 in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Mabworks Biotech Co., Ltd.
About this trial
This is a phase I study evaluating the safety and pharmacokinetics of MBS301 after intravenous administration in patients with HER-2 positive recurrent or metastatic malignant solid tumors
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with HER2-positive recurrent or metastatic malignant solid tumor diagnosed by histopathology or cytology.
Patients with any types of malignant solid tumors who have progressed despite standard therapy or are intolerant of standard therapy, or for which no standard therapy exists.
Patients should have measurable lesions or immeasurable lesions (according to RECIST 1.1).
ECOG physical condition: 0 or 1 point.
Disqualifiers
Absolute neutrophils count (ANC) is less than1.5×109/L and/or blood platelets less than 100 ×109/L and/or hemoglobin less than 9g/dL.
Total bilirubin is more than 1.5 ×ULN.
Patients without hepatic metastasis, ALT or AST is more than 1.5 ×ULN; Patients with hepatic metastasis, ALT or AST is more than 3 ×ULN.
Serum creatinine is more than 1.5 × ULN or estimated creatinine clearance <50 mL/min(according to Cockcroft-Gault).
Trial design
Design model
Single group
Treatments tested in this trial
Recombinant Humanized Bispecific Monoclonal Antibody MBS301
DrugThe patients confirming to the eligibility criteria will be assigned to the 8 dose groups based on the sequence of inclusion. MBS301 will be administered intravenousely on day 1 of each 21-day cycle for each patient.The first intravenous infusion for each patient will be last for 90 minutes.It could be changed to 60 minutes for the subsequent infusions if the drug is well tolerated.
Treatment groups
34 Participants
are divided into 1 treatment groupGroup A: MBS301Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
DLT of MBS301
Evaluate the safety of MBS301 and determine the dose limited toxicity (DLT) .
Time frame
up to the third treatment cycle of the last subject was ended (each cycle is 21 days)2
MTD of MBS301
Evaluate the safety of MBS301 and determine the maximum tolerated dose (MTD).
Time frame
up to the third treatment cycle of the last subject was ended (each cycle is 21 days)Secondary outcomes
1
Investigate the pharmacokinetics profile(Cmax) of MBS301
Maximum Plasma Concentration \[Cmax\]
Time frame
At the end of Cycle 3 (each cycle is 21 days)2
Investigate the pharmacokinetics profile(AUC) of MBS301
Area Under the Curve \[AUC\]
Time frame
At the end of Cycle 3 (each cycle is 21 days)3
Investigate the pharmacokinetics profile(Tmax) of MBS301
Time for Peak concentration\[Tmax\]
Time frame
At the end of Cycle 3 (each cycle is 21 days)4
Investigate the pharmacokinetics profile(MRT) of MBS301
Mean ResidenceTime\[MRT\]
Time frame
At the end of Cycle 3 (each cycle is 21 days)Sponsors and contacts
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Source ClinicalTrials.gov