AzTrials
AzTrials

Advanced or Metastatic Solid TumorsPhase 1/2NCT04843709

A Study of MRG004A in Patients With Tissue Factor Positive Advanced or Metastatic Solid Tumors

A Phase 1/2 study testing MRG004A in people with Advanced or Metastatic Solid Tumors, run by Lepu Biopharma Co., Ltd. at 9 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The objective of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of MRG004A in patients with Tissue Factor positive advanced or metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced or Metastatic Solid Tumors
What is being tested?
MRG004A
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
9 sitesin 2 countries
Study dates
26 Jul 2021to 26 Jul 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Understands and provides written informed consent and willing to follow the requirements specified in protocol.
  • Age ≥18 years.
  • Life expectancy ≥6 months.
  • For Part B patients, documented Tissue Factor (TF) presence in tumor biopsy specimens obtained from archival or re-biopsy specimens by immunohistochemistry (IHC) protein expression.
  • Must have histologically or cytologically confirmed unresectable or metastatic cancer with documented disease progression during prior therapy, or relapse or progression following approved standard therapy for their tumor types- Part A and Part B.
  • Part B: Patients who have documented progression during or relapse following standard therapy, no further treatment options that are known to improve survival, and participation in a clinical trial is a reasonable therapeutic option.
Show all 11Show fewer
  • Patients must have measurable disease per RECIST v1.1.
  • ECOG performance status of 0 or 1.
  • Acceptable bone marrow, hepatic, cardiac, renal, and coagulation function.
  • A negative serum pregnancy test if female and aged between 18-55 years old.
  • Patients, both females and males, of reproductive potential must agree to use adequate contraception during and for 180 days after the last infusion of MRG004A.

Who cannot join

  • Archival or biopsy tumor shows TF IHC membrane or cytosolic score of zero, no TF-positive expression or no TF-positive staining in Part B patients.
  • Toxicities (except alopecia \& fatigue) due to prior antitumor therapy are greater than CTCAE v5.0 Grade 1.
  • Toxicities due to prior radiotherapy that have not resolved to Grade ≤ 1 CTCAE v5.0 at least 21 days prior to the first treatment.
  • Untreated, unstable or uncontrolled central nervous system (CNS) metastases.
  • Any other type of anti-cancer therapy within 21 days of the first dose of study treatment. Use of any other type of anti-cancer treatment is prohibited throughout the study.
  • Patients with increased bleeding risk.
Show all 21Show fewer
  • Presence of severe cardiac dysfunction.
  • Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug.
  • Concurrent malignancy within 5 years prior to entry.
  • Uncontrolled or poorly controlled hypertension.
  • History of ventricular tachycardia, or torsade des pointes.
  • History of moderate to severe dyspnea at rest.
  • Major surgery within 4 weeks of the first dose of study treatment and not fully recovered. Minor surgery within 2 weeks prior to study treatment.
  • Known allergic reactions to any component or excipient of MRG004A or known allergic reactions to other prior anti-TF (including investigational) or other monoclonal antibody ≥ Grade 3.
  • Patients who have any known liver disease, including chronic hepatitis B, hepatitis C, autoimmune hepatic disorders, primary biliary cirrhosis or sclerosing cholangitis; Patients who have concurrent, serious, uncontrolled infections or known infection with HIV, or have a diagnosed acquired immunodeficiency syndrome (AIDS); or an uncontrolled autoimmune disease, or have undergone organ transplant.
  • Active uncontrolled bacterial, viral, fungal, rickettsial, or parasitic infection.
  • Use of systemic corticosteroids within 4 weeks prior to the first dose of treatment.
  • Use of strong CYP3A4 inhibitors or inducers with MRG004A.
  • Other excluded medications or treatment: therapeutic anti-coagulative, or long-term anti-platelet treatment; multivitamins, calcium, vitamin D, and prophylactic anti-RANKL (denosumab) and zoledronic acid therapies for bone metastases are allowed.
  • Any patient with a positive pregnancy or is breast-feeding.
  • Any severe and/or uncontrolled systemic disease that at the discretion of investigator and sponsor makes it undesirable for the patient to participate in this study.

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

United States6 sites

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

  • The Christ Hospital Cancer Center

    Cincinnati, Ohio, 45219

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Gettysburg Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Memorial Sloan Kettering 60th Street Outpatient Center

    New York, New York, 10065

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868-3201

Other trials in United States

China3 sites

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 201321

Other trials in China

About this study

Official title: An Open-Label, Multi-center, Phase I/II Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Anti-Tumor Activity and Pharmacokinetics of MRG004A in Patients With Tissue Factor Positive Advanced or Metastatic Solid Tumors

The objective of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of MRG004A in patients with Tissue Factor positive advanced or metastatic solid tumors.

Read the detailed description

This study consists of two parts. Part A is a dose escalation study to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of MRG004A. Part B is a disease specific multi-cohort dose expansion study to further assess the efficacy and safety of MRG004A at confirmed RP2D.

Being tested
MRG004A
Keywords
MRG004A, Antibody drug conjugate (ADC), Tissue factor, Solid tumors

What participants receive

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

  • MRG004ADrug

    Administrated intravenously

Study groups in NCT04843709
Study groupRoleWhat they receive
MRG004AExperimentalAll patients in Part A (dose escalation) and Part B (dose expansion) will be administrated MRG004A on Day 1 of every 3 weeks (21-day cycle).
Receives: Drug: MRG004A

What is being measured

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

  1. Maximum Tolerated Dose (MTD)

    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: DLT will be evaluated during the first treatment cycle (Day 1-21)

  2. Recommended Phase II Dose (RP2D)

    The dose level of MRG004A recommended for further clinical studies based on assessment of the safety, efficacy and PK data from Part A of this study.

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

  3. Objective Response Rate (ORR)

    The proportion of patients who achieve complete response (CR) or partial response (PR) as assessed by the Independent Central Review (ICR).

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

  4. Adverse Events (AEs)

    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: From signing informed consent until 45 days after the last dose of MRG004A

Secondary outcomes (8)

  1. 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)

  2. Disease Control Rate (DCR)

    The proportion of patients who achieve CR, PR, or stable disease (SD) ≥ 6 weeks based on RECIST v1.1.

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

  3. 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)

  4. Overall Survive (OS)

    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)

  5. Pharmacokinetics (PK) Parameter of MRG004A: Cmax

    Maximum observed plasma concentration.

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

  6. Pharmacokinetics (PK) Parameter of MRG004A: Tmax

    Time to reach the maximum plasma concentration.

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

  7. Pharmacokinetics (PK) Parameter of MRG004A: AUClast

    Area under the plasma 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

  8. Incidence of anti-drug antibody (ADA)

    The proportion of patients with positive ADA immunogenicity results.

    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 posted13 Apr 2021
  2. Study start26 Jul 2021
  3. Primary completion20 Mar 2024
  4. Study completion26 Jul 2024

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
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04843709
Sponsor's protocol ID
MRG004A-001
Status last verified
May 2026
First submitted
8 Apr 2021
Last updated
15 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MRG004A in people with Advanced or Metastatic Solid Tumors, run by Lepu Biopharma Co., Ltd. at 9 sites in 2 countries.

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 11 inclusion and 21 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: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) (time frame: DLT will be evaluated during the first treatment cycle (Day 1-21)). The study lists 4 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 NCT04843709.

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 15 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in