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

NCT07093970 | Recruiting Phase 1

• 1 other identifier: MRG006A-001
• Study Type: interventional
• Target: 343
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Advanced Solid Tumors

Keywords

MRG006A; Antibody Drug Conjugate (ADC); Advanced Solid Tumors

Outcome Measures

Primary Outcomes (5)

• 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).

  Baseline to the end of the first treatment cycle (each cycle is 21 days).

• 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.

  Baseline to study completion (up to 24 months).

• 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.

  Baseline to 30 days after the last dose of study treatment.

• 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.

  Baseline to 30 days after the last dose of study treatment.

• Objective Response Rate (ORR)- Phase II

  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.

  Baseline to study completion (up to 24 months).

Secondary Outcomes (12)

• Objective Response Rate (ORR) - Phase I

  Baseline to study completion (up to 24 months).

• Overall Survive (OS)- Phase II

  Baseline to study completion (up to 24 months).

• Duration of Response (DoR)

  Baseline to study completion (up to 24 months).

• Disease Control Rate (DCR)

  Baseline to study completion (up to 24 months).

• Progression Free Survival (PFS)

  Baseline to study completion (up to 24 months).

Study Arms (1)

MRG006A

EXPERIMENTAL

All patients in Phase I and Phase II will be administrated MRG006A on Day 1 of every 3 weeks (21-day cycle).

Drug: MRG006A

Interventions

MRG006A DRUG

Administrated intravenously

MRG006A

Eligibility Criteria

• Age: 17 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients with histologically or cytologically confirmed advanced solid tumors.
• At least one measurable lesion according to RECISTv1.1 and mRECIST (HCC patients).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Organ function must meet basic requirements.
• Women who are pregnant or breastfeeding are not included in this study.
• Female and male patients of childbearing potential must agree to take adequate measures.

You may not qualify if:

• 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).
• 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.
• Patients at high risk of bleeding.
• Severe cardiac insufficiency within 6 months prior to enrollment.
• Pulmonary embolism or deep venous thrombosis within 3 months before the first study drug treatment;
• History of gastrointestinal perforation, fistula, and bowel obstruction, extensive bowel resection, Crohn 's disease, ulcerative colitis, or chronic diarrhea for the past 6 months.
• Patients with double cancer and multiple cancer.
• 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 and other medical history;
• Allergic reactions to any component or excipient of MRG006A, or known Grade ≥ 3 allergic reactions to other prior anti-GPC3 or other monoclonal antibodies.
• Acute or chronic active hepatitis B or C infection.

Sponsors & Collaborators

• Lepu Biopharma Co., Ltd.: lead

Study Sites (2)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Study Officials

• Jian Zhou, M.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

• Hong Zhao, M.D.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Program Director

CONTACT

86-21-61637960; clinicaltrials@miracogen.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 30, 2025
• Study Start: July 24, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)