Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Recruiting Phase 1/2

A Study of MRG006A in the Treatment of Patients With Advanced Solid Tumors

NCT07093970 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2024-07-24
Last updated
2026-01-22

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

MRG006A →

MRG006A: Administrated intravenously

Study summary

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG006A in patients with advanced solid tumors.

Eligibility

Sex
ALL
Min age
17 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: 1. Understand and provide written informed consent and comply with the requirements set forth in the protocol. 2. age ≥ 18 years, ≤ 75 years. 3. Expected survival ≥ 3 months. 4. For patients with stage I and II disease, tumor tissue samples for GPC3 and P53 testing must be provided. 5. Patients with histologically or cytologically confirmed advanced solid tumors. 6. At least one measurable lesion according to RECISTv1.1 and mRECIST (HCC patients). 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 8. Organ function must meet basic requirements. 9. Women who are pregnant or breastfeeding are not included in this study. 10. Female and male patients of childbearing potential must agree to take adequate measures. Exclusion Criteria: 1. Moderate and above thoracoabdominal pelvic fluid and pericardial effusion with clinical symptoms. 2. History of liver failure and hepatic encephalopathy. 3. 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. 4. Residual toxicity due to previous anti-tumor therapy or clinically significant laboratory abnormalities higher than grade 1 (CTCAEv5.0). 5. For liver cancer, previous or current central nervous system metastases and/or meningeal metastases. Patients with treated stable brain metastases from non-hepatic cancers may participate. 6. Patients at high risk of bleeding. 7. Severe cardiac insufficiency within 6 months prior to enrollment. 8. Pulmonary embolism or deep venous thrombosis within 3 months before the first study drug treatment; 9. History of gastrointestinal perforation, fistula, and bowel obstruction, extensive bowel resection, Crohn 's disease, ulcerative colitis, or chronic diarrhea for the past 6 months. 10. Patients with double cancer and multiple cancer. 11. Uncontrolled or poorly controlled disease. 12. History of ventricular tachycardia or torsades de pointes. 13. Previous or combined interstitial pneumonia, severe chronic obstructive pulmonary disease with respiratory failure, severe pulmonary insufficiency, symptomatic bronchospasm and other medical history; 14. Allergic reactions to any component or excipient of MRG006A, or known Grade ≥ 3 allergic reactions to other prior anti-GPC3 or other monoclonal antibodies. 15. Acute or chronic active hepatitis B or C infection. 16. Active or clinically poorly controlled serious infection. 17. Receiving anti-tuberculosis treatment or receiving anti-tuberculosis treatment within 1 year before the first dose. 18. People infected with human immunodeficiency virus (HIV), known syphilis infection requiring treatment. 19. Use of systemic corticosteroids within 4 weeks prior to first treatment. 20. Use of strong CYP3A4 inducers, strong CYP3A4 inhibitors within 14 days or 5 times the half-life prior to the first dose.

Primary outcome measure(s)

  • Maximum Tolerated Dose (MTD) - Phase I — Baseline to the end of the first treatment cycle (each cycle is 21 days).
    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).
  • Recommended Phase II Dose (RP2D) - Phase I — Baseline to study completion (up to 24 months).
    The dose level of MRG006A recommended for further clinical studies based on assessment of the safety, efficacy and PK data from this study.
  • Adverse Events (AEs) - Phase I — Baseline to 30 days after the last dose of study treatment.
    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.
  • Serious Adverse Events (SAEs) - Phase I — Baseline to 30 days after the last dose of study treatment.
    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.
  • Objective Response Rate (ORR)- Phase II — Baseline to study completion (up to 24 months).
    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.

Trial sites (2)

FacilityCityRegionStatus
Cancer Hospital Chinese Academy of Medical Sciences Beijing Beijing Municipality Recruiting
Zhongshan Hospital, Fudan University Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07093970 on ClinicalTrials.gov ↗ ← All trials in China