Advanced Solid TumorPhase 1NCT04941339
A Study of MRG002 in the Treatment of Patients With HER2-positive Advanced Solid Tumors
A Phase 1 study testing MRG002 in people with Advanced Solid Tumor, run by Shanghai Miracogen Inc. at 1 site in China.
Trial summary
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-positive advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- 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
- 74 participants
- Where
- 1 siteChina
- Study dates
- 21 Nov 2018to Oct 2022
- Phase
- Phase 1
- 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
- Understands and provides written informed consent and willing to follow the requirements specified in protocol;
- Both genders;
- Aged 18 to 75 (including 18 and 75);
- Expected survival time ≥ 12 weeks;
- Patients with histologically and/or cytologically confirmed HER2-positive solid tumors who have failed standard therapy or for whom no standard therapy exists or for whom standard therapy is not appropriate at current stage;
- Patients must have at least one evaluable lesion (Phase Ia) or measurable lesion (Phase Ib) according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1);
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- The score of ECOG for performance status is 0 or 1;
- Prior anti-tumor treatment-related AEs (NCI CTCAE v5.0 Criteria) have recovered to ≤ Grade 1 (except alopecia);
- No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%;
- Organ functions must meet the basic requirements;
- Coagulation function must meet the basic requirements;
- Cumulative anthracycline dose ≤ 360 mg/m2 doxorubicin or its equivalent, 720 mg/m2 epirubicin.
Who cannot join
- Received radiotherapy, chemotherapy, biotherapy, immunotherapy, or other anti-tumor drugs within 3 weeks prior to the first dose of MRG002 treatment;
- History of severe cardiac disease;
- Clinically significant abnormalities in rhythm, conduction, and resting ECG morphology;
- Patients with poorly controlled hypertension or clinically significant vascular disease;
- History of moderate to severe dyspnea at rest due to advanced cancer or their complications, severe primary lung disease, or current need of continuous oxygen therapy, or any history of interstitial lung disease (ILD) or pneumonitis;
- Nausea and vomiting of any kind difficult to control, or chronic gastrointestinal disease;
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- Patients with symptoms of central nervous system or brain metastasis or received treatment for central nervous system or brain metastasis within 3 months prior to the first dose of MRG002 treatment;
- Major surgery not fully recovery within 4 months prior to the first dose of MRG002 treatment;
- History of hypersensitivity to any component of MRG002 or history of hypersensitivity of ≥ Grade 3 to trastuzumab injection;
- Evidence of active infection of hepatitis B or hepatitis C;
- History of immunodeficiency, including human immunodeficiency virus (HIV) infection, or other immunodeficiency disease, or history of organ transplantation;
- Any serious and/or uncontrolled disease or other condition that, considered by the investigator and sponsor, may compromise the patient's participation in this study;
- Received systemic corticosteroids within 4 weeks prior to the first dose of MRG002 treatment;
- 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.
- Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Oriental Hospital
Shanghai, Shanghai Municipality, 200120
Jin Li, Doctor, 86-21-38804518, lijin@csco.org.cn
About this study
Official title: A Phase I, Open-label, Multi-center, First in Human, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Efficacy and Pharmacokinetics of MRG002 in Patients With HER2 Positive Advanced Solid Tumors
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-positive advanced solid tumors.
Read the detailed description
This study consists of two parts. Phase Ia is a dose escalation study to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of MRG002. Phase Ib is a dose expansion study to further assess the efficacy and safety of MRG002 at confirmed RP2D.
- Conditions
- Advanced Solid Tumor
- Being tested
- MRG002
- Keywords
- MRG002, Antibody Drug Conjugate (ADC), HER2, Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRG002Drug
Administrated intravenously
| Study group | Role | What they receive |
|---|---|---|
| MRG002 | Experimental | All patients in Phase Ia (dose escalation) and Phase Ib (dose expansion) will be administrated MRG002 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.
Maximum Tolerated Dose (MTD)
The highest dose confirmed wherein ≤ 1/6 of patients in a treatment cohort experiences a dose-limiting toxicity (DLT).
Measured: DLT will be evaluated during the first treatment cycle (Day 1-28)
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 6 months)
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: Baseline to 49 days after the last dose of study treatment
Secondary outcomes (8)
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects with CR and PR assessed by IRC and investigator according to RECIST v1.1.
Measured: Baseline to study completion (up to 6 months)
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 6 months)
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 6 months)
Pharmacokinetics (PK) parameter of MRG002: Cmax
Maximum observed plasma concentration.
Measured: Baseline to 21 days after the last dose of study treatment
Pharmacokinetics (PK) parameter of MRG002: Tmax
Time to reach maximum plasma concentration.
Measured: Baseline to 21 days after the last dose of study treatment
Pharmacokinetics (PK) parameter of MRG002: t1/2
The time required for plasma concentration to decreased by on half.
Measured: Baseline to 21 days after the last dose of study treatment
Pharmacokinetics (PK) parameter of MRG002: AUClast
Area under the curve up to the last validated measurable plasma concentration.
Measured: Baseline to 21 days after the last dose of study treatment
Immunogenicity
The proportion of patients with positive ADA immunogenicity results.
Measured: Baseline to 21 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.
- First posted28 Jun 2021
- Study start21 Nov 2018
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Miracogen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Li, Doctor, Principal investigator, Shanghai Oriental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941339
- Sponsor's protocol ID
- MRG002-001
- Status last verified
- Dec 2021
- First submitted
- 20 Jun 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Multi-center, First in Human, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Efficacy and Pharmacokinetics of MRG002 in Patients With HER2 Positive Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04941339
- Acronym / sponsor ID
- MRG002-001
- Conditions
- Advanced Solid Tumor
- Keywords
- MRG002, Antibody Drug Conjugate (ADC), HER2, Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Shanghai Miracogen Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-positive advanced solid tumors.
Detailed description
This study consists of two parts. Phase Ia is a dose escalation study to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of MRG002. Phase Ib is a dose expansion study to further assess the efficacy and safety of MRG002 at confirmed RP2D.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRG002 | Experimental | Drug: MRG002All patients in Phase Ia (dose escalation) and Phase Ib (dose expansion) will be administrated MRG002 on Day 1 of every 3 weeks (21-day cycle). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Understands and provides written informed consent and willing to follow the requirements specified in protocol;
- Both genders;
- Aged 18 to 75 (including 18 and 75);
- Expected survival time ≥ 12 weeks;
- Patients with histologically and/or cytologically confirmed HER2-positive solid tumors who have failed standard therapy or for whom no standard therapy exists or for whom standard therapy is not appropriate at current stage;
Key exclusion criteria (15 listed)
- Received radiotherapy, chemotherapy, biotherapy, immunotherapy, or other anti-tumor drugs within 3 weeks prior to the first dose of MRG002 treatment;
- History of severe cardiac disease;
- Clinically significant abnormalities in rhythm, conduction, and resting ECG morphology;
- Patients with poorly controlled hypertension or clinically significant vascular disease;
- History of moderate to severe dyspnea at rest due to advanced cancer or their complications, severe primary lung disease, or current need of continuous oxygen therapy, or any history of interstitial lung disease (ILD) or pneumonitis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRG002Administrated intravenously | Drug | MRG002 |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: DLT will be evaluated during the first treatment cycle (Day 1-28)
The highest dose confirmed wherein ≤ 1/6 of patients in a treatment cohort experiences a dose-limiting toxicity (DLT).
Recommended Phase II Dose (RP2D)
Time frame: Baseline to study completion (up to 6 months)
The dose level of MRG002 recommended for further clinical studies based on assessment of the safety, efficacy and PK data from this study.
Adverse Events (AEs)
Time frame: Baseline to 49 days after the last dose of study treatment
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.
8 secondary outcomes
Objective Response Rate (ORR)
Time frame: Baseline to study completion (up to 6 months)
Duration of Response (DoR)
Time frame: Baseline to study completion (up to 6 months)
Progression Free Survival (PFS)
Time frame: Baseline to study completion (up to 6 months)
Pharmacokinetics (PK) parameter of MRG002: Cmax
Time frame: Baseline to 21 days after the last dose of study treatment
Pharmacokinetics (PK) parameter of MRG002: Tmax
Time frame: Baseline to 21 days after the last dose of study treatment
Pharmacokinetics (PK) parameter of MRG002: t1/2
Time frame: Baseline to 21 days after the last dose of study treatment
Pharmacokinetics (PK) parameter of MRG002: AUClast
Time frame: Baseline to 21 days after the last dose of study treatment
Immunogenicity
Time frame: Baseline to 21 days after the last dose of study treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Li, Doctor principal investigator
Shanghai Oriental Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MRG002 in people with Advanced Solid Tumor, run by Shanghai Miracogen Inc. at 1 site 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 12 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 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
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?
Maximum Tolerated Dose (MTD) (time frame: DLT will be evaluated during the first treatment cycle (Day 1-28)). 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?
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 3 Dec 2021.