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Advanced Malignant Solid TumorsPhase 1/2NCT05338957

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

A Phase 1/2 study testing MRG002+HX008 in people with Advanced Malignant Solid Tumors, run by Shanghai Miracogen Inc. at 5 sites in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Malignant Solid Tumors
What is being tested?
MRG002+HX008
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
5 sitesChina
Study dates
5 Aug 2022to 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing to sign the informed consent form and follow the requirements specified in the protocol.
  • Aged 18 to 75 (including 18 and 75), both genders.
  • Life expectancy ≥ 12 weeks.
  • 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).
  • The score of ECOG for performance status is 0 or 1.
  • The toxicity of previous anti-tumor treatment has recovered to ≤ Grade 1 as defined by NCI-CTCAEv5.0.
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  • No severe cardiac dysfunction.
  • Organ functions must meet the basic requirements.
  • Cumulative dose of anthracycline ≤ 450 mg/m2 doxorubicin or its equivalent.

Who cannot join

  • Prior treatment with chemotherapy, biological therapy, immunotherapy, radiotherapy, investigational drugs, attenuated live vaccines, immunomodulators, CYP3A4 inhibitors/inducers, antibody-drug conjugates, etc.
  • Treatment with immune checkpoint inhibitors or tumor vaccines within 60 days prior to the first dose.
  • Treatment with systemic corticosteroids or other immunosuppressive drugs within 14 days prior to the first dose or during the study period.
  • History of severe cardiac disease.
  • Poorly controlled hypertension and hyperglycemia.
  • Presence of peripheral neuropathy ≥ Grade 2.
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  • 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.
  • Central nervous system metastasis.
  • Received major surgery within 4 weeks prior to the first dose without complete recovery.
  • History of hypersensitivity to any component of MRG002 or HX008 or known history of hypersensitivity of ≥ Grade 3 to macromolecular protein products/monoclonal antibodies.
  • Evidence of active infection.
  • History of primary immunodeficiency or autoimmune disease.
  • 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.
  • Previous history of other primary malignancies.
  • Other conditions inappropriate for participation in this study, as deemed by the investigator.

Trial locations and contacts

5 sites in 1 country.

Program Director contact

86-21-61637960

clinicaltrials@miracogen.com.cn

5 sites in 1 country

China5 sites, 5 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410200

    Zhenyang Liu, Doctor

    Recruiting

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

    Ying yuan, Doctor

    Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong, 250000

    Yuping Sun, Doctor

    Recruiting

  • Shanghai Oriental Hospital

    Shanghai, Shanghai Municipality, 200000

    Jin Li, Doctor, 021-38804518, lijin@csco.org.cn

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

    Suxia Luo, Doctor

    Recruiting

Other trials in China

About this study

Official title: An Open-label, Multi-center, Phase I/II Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of MRG002 in Combination With HX008 in Patients With HER2-expressed Advanced Malignant Solid Tumors.

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.

Being tested
MRG002+HX008
Keywords
MRG002, HX008, Antibody Drug Conjugate (ADC), HER2, PD-1, Solid tumors

What participants receive

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

  • MRG002+HX008Drug

    Administrated intravenously

Study groups in NCT05338957
Study groupRoleWhat they receive
MRG002+HX008ExperimentalMRG002 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.
Receives: Drug: MRG002+HX008

What is being measured

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

  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.

    Measured: 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.

    Measured: 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.

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

Secondary outcomes (8)

  1. Objective Response Rate (ORR)

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

  7. PK parameters: concentration-time curve

    Plot of drug concentration changing with time after drug administration.

    Measured: Baseline to 90 days after the last dose.

  8. Immunogenicity (ADA)

    The proportion of patients with positive ADA results.

    Measured: Baseline to 90 days after the last dose.

Timeline

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

  1. First posted21 Apr 2022
  2. Study start5 Aug 2022
  3. Primary completionJun 2024 (estimated)
  4. Study completionDec 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05338957
Sponsor's protocol ID
MRG002/HX008-C001
Status last verified
Sep 2022
First submitted
15 Apr 2022
Last updated
1 Dec 2022
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 MRG002+HX008 in people with Advanced Malignant Solid Tumors, run by Shanghai Miracogen Inc. at 5 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 9 inclusion and 15 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 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

Results are not available in the source record.

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?

Incidence of dose limiting toxicity (DLT) in each dose group (time frame: Within 28 days after the first dose.). The study lists 3 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 NCT05338957.

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 1 Dec 2022.

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Clinical Trial NCT05338957 | AzTrials