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Advanced Solid TumorsPhase 1/2NCT04492488

A Study of MRG002 in Patients with HER2-Positive Advanced Solid Tumors and Locally Advanced or Metastatic Gastric/Gastroesophageal Junction (GEJ) Cancer

A Phase 1/2 study testing MRG002 in people with Advanced Solid Tumors and Advanced or Metastatic Gastric Cancer, run by Shanghai Miracogen Inc. at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The objective of this study is to assess the safety, efficacy, and pharmacokinetics of MRG002, as well as the immunogenicity as defined by the incidence of anti-drug antibody (ADA) of MRG002 in patients with HER2-positive advanced solid tumors and locally advanced or metastatic gastric/gastroesophageal junction (GEJ)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MRG002
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
2 sitesUnited States
Study dates
24 May 2021to 31 Dec 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

  • The patient must be able to provide written informed consent and follow the requirements specified in protocol.
  • Age: ≥18 years.
  • Life expectancy ≥6 months.
  • Must have histologically or cytologically confirmed HER2-positive metastatic, unresectable cancer and must have had prior disease progression on all standard therapies for their tumor.
  • Available archival tumor tissue (archival or from a new biopsy).
  • At least one non-irradiated measurable tumor lesion according to RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Acceptable liver, renal, hematologic and coagulation function.

Who cannot join

  • Toxicities (except alopecia \& fatigue) due to prior antitumor therapy are higher than CTCAE v5.0 Grade 1.
  • Toxicities due to radiotherapy (higher than grade 1) have not resolved to CTCAE v5.0 Grade ≤1 at least 21 days prior to the screening visit.
  • Prior palliative or therapeutic radiation therapy to any RECIST v1.1 target lesion that defines baseline measurable disease for the study.
  • Untreated or uncontrolled central nervous system (CNS) metastases.
  • Any chemotherapy, biotherapy, immunotherapy, radiotherapy or other anti-tumor therapy within 3 weeks of the first dose of study treatment.
  • Any severe cardiac dysfunction within 6 months of enrollment.
Show all 19Show fewer
  • 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 hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure > 100 mmHg).
  • History of ventricular tachycardia, or torsade des pointes.
  • History of moderate to severe dyspnea at rest due to advanced malignancies or their complications, severe primary lung disease, current need of continuous oxygen therapy, or clinically active interstitial lung disease (ILD) or pneumonitis.
  • 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 MRG002 or known allergic reactions to trastuzumab or other prior anti-HER2 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.
  • 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.
  • Use of systemic corticosteroids within 4 weeks prior to the first dose of treatment.
  • Use of strong CYP3A4 inhibitors.
  • Pregnancy or breast-feeding.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • MD Anderson Cancer Center

    Houston, Texas, 77040

  • University of California Irvine Chao Family Comprehensive Cancer Center

    Orange, California, 92868

Other trials in United States

About this study

Official title: An Open-Label, Multi-center Phase I/II Dose Escalation and Expansion Study to Assess the Safety, Efficacy and Pharmacokinetics of MRG002 in Patients with HER2-Positive Advanced Solid Tumors and Locally Advanced or Metastatic Gastric/Gastroesophageal Junction (GEJ) Cancer

The objective of this study is to assess the safety, efficacy, and pharmacokinetics of MRG002, as well as the immunogenicity as defined by the incidence of anti-drug antibody (ADA) of MRG002 in patients with HER2-positive advanced solid tumors and locally advanced or metastatic gastric/gastroesophageal junction (GEJ) cancer.

Read the detailed description

This study consists of two parts. In Part A, patients will receive MRG002 as a monotherapy at doses of 2.2 or 2.6 mg/kg intravenously (IV) over 60-90 minute on Day 1 of every 3 weeks (Q3W), to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D). In part B, patients will receive a single IV infusion of MRG002 at RP2D on Day 1 of Q3W.

Being tested
MRG002
Keywords
MRG002, Antibody Drug Conjugate (ADC), HER2, Solid tumors, Gastric/GEJ Cancer
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • MRG002Drug

    Administrated intravenously

Study groups in NCT04492488
Study groupRoleWhat they receive
Solid TumorsExperimentalPhase I Dose Escalation: MRG002 will be administrated by an IV infusion of escalating doses (starting dose of 2.2 mg/kg, followed by 2.6 mg/kg) on Day 1 of every 3 weeks (21-day cycle).
Receives: Drug: MRG002
Locally Advanced or Metastatic Gastric/GEJ CancerExperimentalMRG002 will be administrated by an IV infusion on Day 1 of every 3 weeks (21-day cycle).
Receives: Drug: MRG002

What is being measured

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

  1. Maximum Tolerated Dose (MTD)

    The dose level in which (i) less than 2 out of 6 patients in a treatment cohort experiences dose-limiting toxicity (DLT); or (ii) <33% of an evaluable patient treatment cohort experiences DLT.

    Measured: DLT will be evaluated during the first 21-day treatment cycle (Cycle 1)

  2. Recommended Phase II Dose (RP2D)

    Identify the recommended Phase II dose (RP2D) of MRG002 for Phase II clinical study. The RP2D may be the same as the MTD or an evaluable dose level lower than the MTD.

    Measured: Day 1 to Day 21 of Cycle 1

  3. Objective Response Rate (ORR)

    Objective response rate (ORR) will be assessed by Independent Central Review (ICR) based on RECIST v1.1. Cumulative safety and dosing data will be reviewed by an independent Data Safety Monitoring Board (DSMB).

    Measured: Baseline to study completion (24 months)

  4. Incidence of Adverse Events (AEs)

    AEs will be coded using MedDAR. Descriptive statistics will be used to summarize results to assess the safety and tolerability profile of MRG002.

    Measured: After signing informed consent until 45 days after the last dose of MRG002

Secondary outcomes (10)

  1. Duration of Response (DoR)

    Sensitivity analyses of DoR from the Investigator's assessment will be performed in the final analysis.

    Measured: Baseline to study completion (24 months)

  2. Disease Control Rate (DCR)

    Sensitivity analyses of DCR from the Investigator's assessment will be performed in the final analysis.

    Measured: Baseline to study completion (24 months)

  3. Progression Free Survival (PFS)

    Sensitivity analyses of PFS from the Investigator's assessment will be performed in the final analysis.

    Measured: Baseline to study completion (24 months)

  4. Pharmacokinetics (PK) parameter for MRG002: Maximum Drug Concentration (Cmax)

    Cmax will be derived from the PK blood samples collected and will be summarized with descriptive statistics.

    Measured: Baseline to study completion (24 months)

  5. PK parameter for MRG002: Area Under the Curve Up to the Last Validated Measurable Plasma Concentration (AUClast)

    AUClast will be derived from the PK blood samples collected and will be summarized with descriptive statistics.

    Measured: Baseline to study completion (24 months)

  6. PK parameter for total antibody (TAb): Cmax

    Cmax will be derived from the PK blood samples collected and will be summarized with descriptive statistics.

    Measured: Baseline to study completion (24 months)

  7. PK parameter for TAb: AUClast

    AUClast will be derived from the PK blood samples collected and will be summarized with descriptive statistics.

    Measured: Baseline to study completion (24 months)

  8. PK parameter for Monomethyl Auristatin E (MMAE): Cmax

    Cmax will be derived from the PK blood samples collected and will be summarized with descriptive statistics.

    Measured: Baseline to study completion (24 months)

  9. PK parameter for MMAE: AUClast

    AUClast will be derived from the PK blood samples collected and will be summarized with descriptive statistics.

    Measured: Baseline to study completion (24 months)

  10. Immunogenicity

    5 mL Blood samples for anti-drug antibody (ADA) analysis will be collected each time according to the pre-defined timepoints. The incidence of ADA will be summarized for all patients who received at least one administration of MRG002.

    Measured: Baseline to study completion (24 months)

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 2020
  2. Study start24 May 2021
  3. Primary completion18 Oct 2022
  4. Study completion31 Dec 2024 (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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
129 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04492488
Sponsor's protocol ID
MRG002-101
Status last verified
Oct 2024
First submitted
23 Jul 2020
Last updated
22 Oct 2024
Results posted
No
Data monitoring committee
Yes
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 MRG002 in people with Advanced Solid Tumors and Advanced or Metastatic Gastric Cancer, run by Shanghai Miracogen Inc. at 2 sites in United States.

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 8 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 22 Oct 2024. 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 United States. 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?

Results are not available in the source record.

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 21-day treatment cycle (Cycle 1)). 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 NCT04492488.

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 Oct 2024.

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