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A Clinical trial to evaluate the pharmacokinetics, safety, efficacy and immunogenicity of Bmab-100 and Avastin in patients with metastatic colorectal cancer

ABSTRACT: Intervention1: Bmab-100: administered intravenously 7.5 mg/kg/body weight once every 3 weeks for 6 cycles. Control Intervention1: Avastin (Roches bevacizumab): to administer 7.5mg/kg once evry 3 weeks for 6 cycles Primary outcome(s): Single dose pharmacokinetic parameters for Bmab-100 and AvastinÂ in terms of AUC0-t and Cmax [Cycle 1]Timepoint: Single dose pharmacokinetic parameters for Bmab-100 and AvastinÂ in terms of AUC0-t and Cmax [Cycle 1] Study Design: Randomized, Parallel Group Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

DISEASE(S): In Patients With Metastatic Colorectal Cancer (mcrc)

PROVIDER: 2576020 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Stage 1 of the trial - dose escalation Cohort 1: 200mg tablet Sorafenib once daily and 200 mg capsule MG010 once daily for up to one cycle (28 days) Cohort 2: 200mg tablet Sorafenib once daily and 400 mg capsules MG010 once daily for one cycle (28 days) Cohort -1: 200mg tablet Sorafenib once daily and 100 mg capsule MG010 once daily for one cycle (28 days) Cohort and Phase Timing: Cohort 1 concludes when all subjects complete their cycles, then safety assessments are undertaken within 7 days of the last patients. If Dose Limiting Toxicity (DLT) is observed in >1 out of 6 subjects in cohort 1, 3 subjects will be recruited for dose cohort -1 (dose de-escalation); Cohort 2 commences with 3 new patients and after all subjects complete their cycles, then within 7 days safety assessments are performed. After approximately 2 weeks, if all goes well, the report of the safety committee will be finalised, after which stage 2 will commence if the report provides a favourable recommendation. Stage 1 participants are eligible for stage 2, subject to signing a new informed consent and compliance with the inclusion exclusion criteria. Stage 2 of the trial - dose expansion stage The dose will be decided at the completion of stage 1. Sorafenib once daily and MG010 once or twice daily for up to six cycles (168 days) Adherence will be monitored by returned medication counts. Primary outcome(s): Phase I: PK Composite Outcome Measures Individual plasma concentrations of MG010 and sorafenib collected at specified time points will be used to calculate pharmacokinetic parameters using a non-compartmental approach. Data will be listed for all subjects with available MG010 concentrations. Pharmacokinetic parameters to be determined may include: • Peak plasma concentration at steady state (Cmax,ss) • Time to reach peak concentration at steady state (Tmax,ss) • Trough plasma concentration (Ctrough) • Minimum plasma concentration at steady state (Cmin,ss) • AUC in 1 dosing interval at steady state (AUC0>t,ss) • Average concentration at steady state (Cave): AUC0>t,ss/t? • Fluctuation: (Cmax,ss Cmin,ss)/Cave [Day 1 at -0.5 hr pre-dose, 0.5 hr post-dose, subsequently at 1,2,3,4,5,6,8,23 and 24 hr post dose];Phase I and II: Safety Outcome Measures The safety assessments selected for this study will include the assessment of vital signs, 12-lead electrocardiograms, clinical safety, laboratory examinations, physical examinations, and adverse events. Safety endpoints include: • SAEs and/or TEAEs, regardless of causality or relationship • Vital Signs - Systolic and diastolic blood pressure, pulse rate, body temperature, and body weight • 12-lead electrocardiograms • Clinically relevant changes in laboratory measurements [At each visit (Screening, Day 1, Day 7, Day 14, Day 21, Day 28 and Day 56) safety outcome measures are assessed. In addition: Phase I: After 7 days of the first dose, the safety review committee will assess the safety of the participant. Then there will be data safety committee who will conduct assessments on a regular basis for each cohort. Phase II: An independent Data Safety Monitoring Board will be formed. They will review the safety of the study on a quarterly basis. ];Phase II: Efficacy Outcome Measures • Disease control rate (DCR): subjects achieving any one of the following responses: confirmed complete response (CR), confirmed partial response (PR) or stable disease (SD) during the study (up to and including visit 9) as per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria. [For the phase I study, the assessment will be performed on day 56. For the phase II study, the tumour response assessments will occur on days 56, 112, 168 and day 210. ] Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Other;Type of endpoint: Safety/efficacy

Dataset Information

A Clinical trial to evaluate the pharmacokinetics, safety, efficacy and immunogenicity of Bmab-100 and Avastin in patients with metastatic colorectal cancer

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