A Study of MRG006A in the Treatment of Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age17-85
SponsorLepu Biopharma Co., Ltd.
About this trial
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG006A in patients with advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Understand and provide written informed consent and comply with the requirements set forth in the protocol.
age ≥ 18 years, ≤ 75 years.
Expected survival ≥ 3 months.
For patients with stage I and II disease, tumor tissue samples for GPC3 and P53 testing must be provided.
Disqualifiers
Moderate and above thoracoabdominal pelvic fluid and pericardial effusion with clinical symptoms.
History of liver failure and hepatic encephalopathy.
Portal vein tumor thrombus involving both the main portal vein and left and right branches, or involving both the main portal vein and mesenteric vein needs to be excluded. The tumor involves the vena cava, or has formed a vena cava tumor thrombus.
Residual toxicity due to previous anti-tumor therapy or clinically significant laboratory abnormalities higher than grade 1 (CTCAEv5.0).
Trial design
Design model
Single group
Treatments tested in this trial
MRG006A
DrugAdministrated intravenously
Treatment groups
343 Participants
are divided into 1 treatment groupGroup A: MRG006AExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum Tolerated Dose (MTD) - Phase I
The highest dose confirmed wherein less than 2 out of 6, or \< 33% of evaluable patients in a treatment cohort experiences dose-limiting toxicity (DLT).
Time frame
Baseline to the end of the first treatment cycle (each cycle is 21 days).2
Recommended Phase II Dose (RP2D) - Phase I
The dose level of MRG006A recommended for further clinical studies based on assessment of the safety, efficacy and PK data from this study.
Time frame
Baseline to study completion (up to 24 months).3
Adverse Events (AEs) - Phase I
Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.
Time frame
Baseline to 30 days after the last dose of study treatment.4
Serious Adverse Events (SAEs) - Phase I
Adverse events that are fatal, life-threatening, or result in hospitalization or prolonged hospitalization, persistent or significant disability/incapacity/substantial disruption of the ability to lead a normal life, congenital anomaly/birth defect or major medical events or reactions.
Time frame
Baseline to 30 days after the last dose of study treatment.Secondary outcomes
1
Objective Response Rate (ORR) - Phase I
ORR is defined as the proportion of subjects with CR and PR assessed by IRC and investigator according to RECIST v1.1 and mRECIST（HCC patients）. And determine the objective response rate (CR + PR) and its 95% confidence interval.
Time frame
Baseline to study completion (up to 24 months).2
Overall Survive (OS)- Phase II
The time from start of study treatment to date of death as a result of any cause.
Time frame
Baseline to study completion (up to 24 months).3
Duration of Response (DoR)
The time interval between the date of the earliest qualifying response and the date of disease progression or death for any cause, whichever occurs earlier.
Time frame
Baseline to study completion (up to 24 months).4
Disease Control Rate (DCR)
The proportion of patients who achieve CR, PR, or stable disease (SD) after treatment.
Time frame
Baseline to study completion (up to 24 months).Sponsors and contacts
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Source ClinicalTrials.gov