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Status unknownNCT05338957Updated Dec 1, 2022

A Study of MRG002 in the Treatment of Patients With HER2-expressed Advanced Malignant Solid Tumors.

A Phase 1/2 interventional study of MRG002+HX008 in Advanced Malignant Solid Tumors, sponsored by Shanghai Miracogen Inc.. Status unknown at 5 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-12-01.

Sponsored by Shanghai Miracogen Inc. · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The objective of this study is to assess the safety and tolerability of MRG002 in combination with HX008 in patients with HER2-expressed advanced malignant solid tumors; and to , explore the maximum tolerated dose (MTD), and to determine the recommended phase II dose (RP2D) of combination therapy; , and to evaluate the preliminary efficacy, pharmacokinetics, and immunogenicity of combination therapy in the targeted study population.

02

Conditions studied

  • Advanced Malignant Solid Tumors

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Keywords

  • MRG002
  • HX008
  • Antibody Drug Conjugate (ADC)
  • HER2
  • PD-1
  • Solid tumors
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 30 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Shanghai Miracogen Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Willing to sign the informed consent form and follow the requirements specified in the protocol.
  2. Aged 18 to 75 (including 18 and 75), both genders.
  3. Life expectancy ≥ 12 weeks.
  4. Patients with histopathological or cytological confirmed HER2-expressed advanced solid tumors, and with at least one measurable lesion according to the Response Criteria in Solid Tumors (RECIST v1.1).
  5. The score of ECOG for performance status is 0 or 1.
  6. The toxicity of previous anti-tumor treatment has recovered to ≤ Grade 1 as defined by NCI-CTCAEv5.0.
  7. No severe cardiac dysfunction.
  8. Organ functions must meet the basic requirements.
  9. Cumulative dose of anthracycline ≤ 450 mg/m2 doxorubicin or its equivalent.

Exclusion criteria

Exclusion Criteria:

  1. Prior treatment with chemotherapy, biological therapy, immunotherapy, radiotherapy, investigational drugs, attenuated live vaccines, immunomodulators, CYP3A4 inhibitors/inducers, antibody-drug conjugates, etc.
  2. Treatment with immune checkpoint inhibitors or tumor vaccines within 60 days prior to the first dose.
  3. Treatment with systemic corticosteroids or other immunosuppressive drugs within 14 days prior to the first dose or during the study period.
  4. History of severe cardiac disease.
  5. Poorly controlled hypertension and hyperglycemia.
  6. Presence of peripheral neuropathy ≥ Grade 2.
  7. History of moderate or severe dyspnea at rest due to advanced malignant tumor or its complications or severe primary pulmonary disease, or current need of continuous oxygen therapy, or current interstitial lung disease or pneumonia.
  8. Central nervous system metastasis.
  9. Received major surgery within 4 weeks prior to the first dose without complete recovery.
  10. History of hypersensitivity to any component of MRG002 or HX008 or known history of hypersensitivity of ≥ Grade 3 to macromolecular protein products/monoclonal antibodies.
  11. Evidence of active infection.
  12. History of primary immunodeficiency or autoimmune disease.
  13. Female patients with a positive serum pregnancy test or who are breast-feeding or who do not agree to take adequate contraceptive measures during the treatment and for 6 months after the last dose of study treatment.
  14. Previous history of other primary malignancies.
  15. Other conditions inappropriate for participation in this study, as deemed by the investigator.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    MRG002+HX008

    MRG002 will be administrated via intravenous infusion at 1.8，,2.2, or 2.6 mg/kg , (if appropriate) once on Day 1 of every 3 weeks (21-day cycle), up to 24 months. HX008 will be administrated via intravenous infusion at 3 mg/kg once on Day 1 of every 3 weeks (21-day- cycle), up to 24 months.

    Drug: MRG002+HX008

Interventions

  • DrugMRG002+HX008

    Administrated intravenously

06

What researchers measure

Primary outcomes

  1. Incidence of dose limiting toxicity (DLT) in each dose group

    DLT is defined as any of the treatment emergent adverse events (TEAE) as specified in the protocol that bear a definite, probable, or possible causal relationship to study drug administration within 28 days after the first dose.

    Time frame: Within 28 days after the first dose.

  2. Adverse events

    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.

    Time frame: After signing informed consent until 90 days after the last dose.

  3. Recommended Phase II Dose (RP2D)

    The dose level of MRG002 recommended for further clinical studies based on assessment of the safety, efficacy and PK data from this study.

    Time frame: Baseline to study completion (up to 24 months)

Secondary outcomes

  1. Objective Response Rate (ORR)

    ORR is defined as the proportion of subjects with CR and PR according to RECIST v1.1.

    Time frame: Baseline to study completion (up to 24 months)

  2. Duration of Response (DOR)

    DOR is defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause.

    Time frame: Baseline to study completion (up to 24 months)

  3. Disease Control Rate (DCR)

    DCR is defined as the proportion of subjects achieving CR, PR, and SD after treatment.

    Time frame: Baseline to study completion (up to 24 months)

  4. Progression Free Survival (PFS)

    PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.

    Time frame: Baseline to study completion (up to 24 months)

  5. Time to Response (TTR)

    TTR is defined as the time from the start of treatment until the first occurrence of CR or PR by tumor assessment.

    Time frame: Baseline to study completion (up to 24 months)

  6. Overall Survival (OS)

    OS is defined as the duration from the start of treatment to death of any cause.

    Time frame: Baseline to study completion (up to 24 months)

  7. PK parameters: concentration-time curve

    Plot of drug concentration changing with time after drug administration.

    Time frame: Baseline to 90 days after the last dose.

  8. Immunogenicity (ADA)

    The proportion of patients with positive ADA results.

    Time frame: Baseline to 90 days after the last dose.

07

Study locations

5 of 5 sites recruiting
  • Henan Cancer Hospital
    Zhengzhou, Henan 450000, China
    • Suxia Luo, Doctor · Contact
    Recruiting
  • Hunan Cancer Hospital
    Changsha, Hunan 410200, China
    • Zhenyang Liu, Doctor · Contact
    Recruiting
  • Shandong Cancer Hospital
    Jinan, Shandong 250000, China
    • Yuping Sun, Doctor · Contact
    Recruiting
  • Shanghai Oriental Hospital
    Shanghai, Shanghai 200000, China
    Recruiting
  • The Second Affiliated Hospital of Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310000, China
    • Ying yuan, Doctor · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05338957
Lead sponsor
Shanghai Miracogen Inc.
Responsible party
Sponsor
First posted
Apr 21, 2022
Start date
Aug 5, 2022
Primary completion
Jun 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Dec 1, 2022

Study contacts

Program Director
Contact
clinicaltrials@miracogen.com.cn
86-21-61637960
Jin Li, MD
principal investigator · Shanghai Oriental Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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