Actively Recruiting
A Study of MRG006A in the Treatment of Patients With Advanced Solid Tumors
Led by Lepu Biopharma Co., Ltd. · Updated on 2026-01-22
343
Participants Needed
2
Research Sites
227 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG006A in patients with advanced solid tumors.
CONDITIONS
Official Title
A Study of MRG006A in the Treatment of Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and provide written informed consent
- Age between 18 and 75 years
- Expected survival of at least 3 months
- For stage I and II disease, provide tumor tissue samples for GPC3 and P53 testing
- Histologically or cytologically confirmed advanced solid tumors
- At least one measurable lesion according to RECISTv1.1 and mRECIST (for HCC patients)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Basic organ function requirements met
- Women who are pregnant or breastfeeding are not eligible
- Female and male patients of childbearing potential must agree to use adequate birth control measures
You will not qualify if you...
- Moderate or severe fluid buildup in chest, abdomen, or around heart with symptoms
- History of liver failure or hepatic encephalopathy
- Tumor thrombus involving both main portal vein and branches, vena cava involvement, or vena cava tumor thrombus
- Residual toxicity from previous anti-tumor therapy or lab abnormalities above grade 1
- For liver cancer, current or previous central nervous system or meningeal metastases (except stable treated brain metastases from non-liver cancers)
- High risk of bleeding
- Severe cardiac insufficiency within 6 months before enrollment
- Pulmonary embolism or deep venous thrombosis within 3 months before treatment
- History of gastrointestinal perforation, fistula, bowel obstruction, extensive bowel surgery, Crohn's disease, ulcerative colitis, or chronic diarrhea in past 6 months
- Presence of double or multiple cancers
- Uncontrolled or poorly controlled disease
- History of ventricular tachycardia or torsades de pointes
- Previous or combined interstitial pneumonia, severe chronic obstructive pulmonary disease with respiratory failure, severe pulmonary insufficiency, symptomatic bronchospasm
- Allergic reaction to any MRG006A components or severe allergy to prior anti-GPC3 or monoclonal antibodies
- Active or chronic hepatitis B or C infection
- Active or poorly controlled serious infection
- Receiving or received anti-tuberculosis treatment within 1 year before dosing
- Infection with HIV or syphilis requiring treatment
- Use of systemic corticosteroids within 4 weeks before treatment
- Use of strong CYP3A4 inducers or inhibitors within 14 days or 5 half-lives before treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
2
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
P
Program Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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