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Advanced Solid TumorsPhase 1/2NCT07093970

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

A Phase 1/2 study testing MRG006A in people with Advanced Solid Tumors, run by Lepu Biopharma Co., Ltd. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 17 to 85 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
MRG006A
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
343 participants
Where
2 sitesChina
Study dates
24 Jul 2024to Dec 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 85 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Active or clinically poorly controlled serious infection.
  • Receiving anti-tuberculosis treatment or receiving anti-tuberculosis treatment within 1 year before the first dose.
  • People infected with human immunodeficiency virus (HIV), known syphilis infection requiring treatment.
  • Use of systemic corticosteroids within 4 weeks prior to first treatment.
  • Use of strong CYP3A4 inducers, strong CYP3A4 inhibitors within 14 days or 5 times the half-life prior to the first dose.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Program Director contact

86-21-61637960

clinicaltrials@miracogen.com.cn

China2 sites, 2 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Hong Zhao, M.D, 86-10-87787100, zhou.jian@zs-hospital.sh.cn

    Recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

    Jian Zhou, M.D, 86-21-64041990, pumczhaohong@126.com

    Recruiting

Other trials in China

About this study

Official title: A Phase I/II, Open-label, Multi-center, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Efficacy and Pharmacokinetics of MRG006A in Patients With Advanced Solid Tumors

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

Read the detailed description

This study consists of two parts. Phase I is a dose escalation study to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of MRG006A. Phase II is a dose expansion study to further assess the efficacy, safety, pharmacokinetics and immunogenicityof MRG006A at confirmed RP2D.

Being tested
MRG006A
Keywords
MRG006A, Antibody Drug Conjugate (ADC), Advanced Solid Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRG006ADrug

    Administrated intravenously

Study groups in NCT07093970
Study groupRoleWhat they receive
MRG006AExperimentalAll patients in Phase I and Phase II will be administrated MRG006A on Day 1 of every 3 weeks (21-day cycle).
Receives: Drug: MRG006A

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

  5. 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.

    Measured: Baseline to study completion (up to 24 months).

Secondary outcomes (12)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline to study completion (up to 24 months).

  5. Progression Free Survival (PFS)

    The time from the date of first study dose to disease progression or death whichever occurs first.

    Measured: Baseline to study completion (up to 24 months).

  6. Cmax

    Maximum observed blood concentration

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

  7. Tmax

    Time to reach the maximum blood concentration.

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

  8. AUC0-t

    Area under the blood concentration-time curve from time 0 to the time of last quantifiable concentration.

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

  9. Incidence of anti-drug antibody (ADA)

    The proportion of patients with positive ADA results.

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

  10. QT interval corrected by Fridericia's formula（QTcF）

    Evaluate the effect of MRG006A on the prolongation of QT interval corrected by heart rate using Fridericia's formula (QTcF) in patients with advanced solid tumors.

    Measured: Baseline to 15 days after the third dose of study treatment.

  11. Adverse Events (AEs) - Phase II

    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.

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

  12. Serious Adverse Events (SAEs) - Phase II

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2025
  2. Study start24 Jul 2024
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
343 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07093970
Sponsor's protocol ID
MRG006A-001
Status last verified
Jan 2026
First submitted
22 Jul 2025
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MRG006A in people with Advanced Solid Tumors, run by Lepu Biopharma Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Program Director (86-21-61637960, clinicaltrials@miracogen.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) - Phase I (time frame: Baseline to the end of the first treatment cycle (each cycle is 21 days).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07093970.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.

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