Advanced or Metastatic Urothelium CancerPhase 3NCT05754853
A Study of MRG002 Versus Investigator's Choice of Chemotherapy in the Treatment of Patients With HER2-positive Unresectable Advanced or Metastatic Urothelial Cancer
A Phase 3 study testing MRG002, Docetaxel Injection and Paclitaxel Injection in people with Advanced or Metastatic Urothelium Cancer, run by Shanghai Miracogen Inc. at 1 site in China.
Trial summary
The primary objective of this study is to compare the overall survival (OS) and progression-free survival (PFS) between MRG002 and investigator selected chemotherapy in patients with HER2-positive unresectable locally advanced or metastatic urothelial cancer previously treated with platinum-based chemotherapy and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced or Metastatic Urothelium Cancer
- What is being tested?
- MRG002, Docetaxel Injection and Paclitaxel Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2023to Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- 1. Willing to sign the ICF and follow the requirements specified in the protocol.
- 2. Aged 18 to 75 (including 18 and 75), both genders. 3. Expected survival time ≥ 12 weeks. 4. Patients with unresectable locally advanced or metastatic urothelium cancer confirmed by histopathology.
- 5. Patients who have failed prior platinum-based chemotherapy and PD-1/PD-L1 inhibitors and have have progressive disease or recurrence on or after their most recent therapy.
- 6. Archival or biopsy tumor specimens should be provided (primary or metastatic).
- 7. HER2 positive (IHC 3+ or IHC 2+) in the tumor specimens confirmed by central laboratory test.
- 8. Patients must have measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- 9. ECOG performance score 0 or 1. 10. Prior anti-tumor treatment-related AEs (NCI-CTCAE v5.0 Criteria) have recovered to ≤ Grade 1 (except alopecia, Grade 2 hypothyroidism, non-clinically significant or asymptomatic laboratory abnormalities).
- 11. Organ function must meet the basic requirements. 12. Patients of childbearing potential must take effective contraceptive measures during the treatment and for 180 days after the last dose of treatment.
Who cannot join
- 1. History of hypersensitivity to any component of MRG002 or history of hypersensitivity of ≥ Grade 3 to trastuzumab.
- 2. Patients who have received ADC drugs, or prior taxane, gemcitabine, and pemetrexed for locally advanced or metastatic urothelial cancer; or have received investigational drugs from other clinical trials, chemotherapy, radiotherapy, targeted therapy, or immunotherapy within 4 weeks prior to the first dose; or have received Chinese medicine (herbal medicine) or Chinese patent medicine with anti-tumor indications within 2 weeks prior to the first dose; or have received strong CYP3A4 inhibitors within 2 weeks prior to the first dose or have current requirement of CYP3A4 inhibitors; or had major surgery within 4 weeks prior to the first dose without full recovery or planned surgery within 12 weeks after study treatment.
- 3. Patients with clinical symptoms such as plural, abdominal or pericardial effusion requiring puncture drainage.
- 4. Patients with central nervous system (CNS) metastasis and/or neoplastic meningitis.
- 5. Any severe or uncontrolled systemic diseases. 6. Patients with poorly controlled heart diseases. 7. Evidence of active infections, including but not limited to Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection.
- 8. History of other primary malignancies. 9. History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.
- 10. Peripheral neuropathy greater than Grade 1. 11. History of cirrhosis. 12. Patients with active autoimmune disease or a history of autoimmune disease, who are using immunosuppressive agents, or systemic hormone therapy and still receiving them within 2 weeks prior to enrollment.
- 13. Uncontrolled tumor-associated bone pain or urgent spinal cord compression. Patients requiring pain control must have been on a stable treatment regimen for at least 2 weeks at the time of first dose 14. Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100000
Aiping Zhou, MD, 86-10-87788800, zhouap1825@126.com
About this study
Official title: An Open-label, Randomized, Multi-center, Phase III Clinical Study of MRG002 Versus Investigator's Choice of Chemotherapy in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Urothelial Cancer Previously Treated With Platinum-based Chemotherapy and PD-1/PD-L1 Inhibitors
The primary objective of this study is to compare the overall survival (OS) and progression-free survival (PFS) between MRG002 and investigator selected chemotherapy in patients with HER2-positive unresectable locally advanced or metastatic urothelial cancer previously treated with platinum-based chemotherapy and PD-1/PD-L1 inhibitors.
Read the detailed description
This study aims to enroll 290 patients. Participants will be randomly assigned to receive treatment of MRG002 or investigator selected chemotherapy in a 1:1 ratio. The efficacy of MRG002 will be assessed by patient's OS, PFS and other indicators as compared to investigator selected chemotherapy. Additionally, this study will assess the pharmacokinetic profile, immunogenicity, safety, tolerability, and treatment compliance of MRG002.
- Conditions
- Advanced or Metastatic Urothelium Cancer
- Being tested
- MRG002, Docetaxel Injection, Paclitaxel Injection, Gemcitabine Hydrochloride for Injection, Pemetrexed Disodium Injection
- Keywords
- MRG002, Antibody Drug Conjugate (ADC), HER2, Urothelium Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRG002Drug
Administrated intravenously
Docetaxel InjectionDrug
Administrated intravenously
Paclitaxel InjectionDrug
Administrated intravenously
Gemcitabine Hydrochloride for InjectionDrug
Administrated intravenously
Pemetrexed Disodium InjectionDrug
Administrated intravenously
| Study group | Role | What they receive |
|---|---|---|
| MRG002 | Experimental | MRG002 will be administrated by an IV infusion of 2.2 mg/kg on Day 1 of every 3 weeks (21-day cycle). Receives: Drug: Docetaxel Injection; Drug: Paclitaxel Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: Pemetrexed Disodium Injection |
| Docetaxel /Paclitaxel /Gemcitabine Hydrochloride /Pemetrexed Disodium Injection | Active comparator | Docetaxel injection will be administered by an IV infusion of 75 mg/m2 on Day 1 of every 3 weeks (21-day cycle); Paclitaxel will be administrated by an IV infusion of 175 mg/m2 on Day 1 of every 3 weeks (21-day cycle).
Gemcitabine Hydrochloride will be administrated by an IV infusion of 1000 mg/m2 on Day 1 and Day 8 of every 3 weeks (21-day cycle).
Pemetrexed Disodium will be administrated by an IV infusion of 500 mg/m2 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.
Overall Survival (OS)
OS is defined as the time from the date of randomization until death of any cause.
Measured: Baseline to study completion (up to 36 months)
Progression-Free Survival (PFS) by Independent Review Committee (IRC)
PFS is defined as the duration from the date of randomization to the onset of tumor progression or death of any cause.
Measured: Baseline to study completion (up to 36 months)
Secondary outcomes (10)
Objective Response Rate (ORR)
ORR is defined as the percentage of patients with a complete response (CR) or partial response (PR) according to RECIST v1.1.
Measured: Baseline to study completion (up to 36 months)
Duration of Response (DoR)
DoR is defined as the time from first documented objective response (CR/PR) to the first onset of tumor progression or death of any nonsurgical cause.
Measured: Baseline to study completion (up to 36 months)
Disease Control Rate (DCR)
DCR is defined as the percentage of patients who achieve CR, PR, and stable disease (SD).
Measured: Baseline to study completion (up to 36 months)
Clinical Benefit Rate (CBR)
CBR is defined as the percentage of patients who achieve CR, PR, and SD for ≥ 6 months.
Measured: Baseline to study completion (up to 36 months)
Time to Response (TTR)
TTR is defined as the duration from randomization to the first documented objective response (CR/PR).
Measured: Baseline to study completion (up to 36 months)
PFS by investigator
PFS is defined as the duration from the date of randomization to the onset of tumor progression or death of any cause.
Measured: Baseline to study completion (up to 36 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 30 days after the last dose of study treatment
Pharmacokinetics (PK) Parameter of MRG002: concentration-time curve
Plot of drug concentration changing with time after drug administration.
Measured: Baseline to 7 days after discontinuation of treatment
Anti-drug antibody (ADA)
The proportion of patients with positive ADA results and its titer.
Measured: Baseline to 7 days after discontinuation of treatment
Neutralizing antibody (NAb)
The proportion of patients with positive NAb results and its titer.
Measured: Baseline to 7 days after discontinuation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start6 Apr 2023 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Urothelium CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Miracogen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aiping Zhou, MD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical SciencesFangjian Zhou, MD, Principal investigator, Sun Yat-sen University Cancer Prevention Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754853
- Sponsor's protocol ID
- MRG002-010
- Status last verified
- Apr 2023
- First submitted
- 22 Feb 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multi-center, Phase III Clinical Study of MRG002 Versus Investigator's Choice of Chemotherapy in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Urothelial Cancer Previously Treated With Platinum-based Chemotherapy and PD-1/PD-L1 Inhibitors
- ClinicalTrials.gov ID
- NCT05754853
- Acronym / sponsor ID
- MRG002-010
- Conditions
- Advanced or Metastatic Urothelium Cancer
- Keywords
- MRG002, Antibody Drug Conjugate (ADC), HER2, Urothelium Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Shanghai Miracogen Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Apr 2023 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 6 Mar 2023 (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 primary objective of this study is to compare the overall survival (OS) and progression-free survival (PFS) between MRG002 and investigator selected chemotherapy in patients with HER2-positive unresectable locally advanced or metastatic urothelial cancer previously treated with platinum-based chemotherapy and PD-1/PD-L1 inhibitors.
Detailed description
This study aims to enroll 290 patients. Participants will be randomly assigned to receive treatment of MRG002 or investigator selected chemotherapy in a 1:1 ratio. The efficacy of MRG002 will be assessed by patient's OS, PFS and other indicators as compared to investigator selected chemotherapy. Additionally, this study will assess the pharmacokinetic profile, immunogenicity, safety, tolerability, and treatment compliance of MRG002.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRG002 | Experimental | Drug: Docetaxel Injection, Drug: Paclitaxel Injection, Drug: Gemcitabine Hydrochloride for Injection, Drug: Pemetrexed Disodium InjectionMRG002 will be administrated by an IV infusion of 2.2 mg/kg on Day 1 of every 3 weeks (21-day cycle). |
| Docetaxel /Paclitaxel /Gemcitabine Hydrochloride /Pemetrexed Disodium Injection | Active comparator | Drug: MRG002Docetaxel injection will be administered by an IV infusion of 75 mg/m2 on Day 1 of every 3 weeks (21-day cycle); Paclitaxel will be administrated by an IV infusion of 175 mg/m2 on Day 1 of every 3 weeks (21-day cycle). Gemcitabine Hydrochloride will be administrated by an IV infusion of 1000 mg/m2 on Day 1 and Day 8 of every 3 weeks (21-day cycle). Pemetrexed Disodium will be administrated by an IV infusion of 500 mg/m2 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 (8 listed)
- 1. Willing to sign the ICF and follow the requirements specified in the protocol.
- 2. Aged 18 to 75 (including 18 and 75), both genders. 3. Expected survival time ≥ 12 weeks. 4. Patients with unresectable locally advanced or metastatic urothelium cancer confirmed by histopathology.
- 5. Patients who have failed prior platinum-based chemotherapy and PD-1/PD-L1 inhibitors and have have progressive disease or recurrence on or after their most recent therapy.
- 6. Archival or biopsy tumor specimens should be provided (primary or metastatic).
- 7. HER2 positive (IHC 3+ or IHC 2+) in the tumor specimens confirmed by central laboratory test.
Key exclusion criteria (8 listed)
- 1. History of hypersensitivity to any component of MRG002 or history of hypersensitivity of ≥ Grade 3 to trastuzumab.
- 2. Patients who have received ADC drugs, or prior taxane, gemcitabine, and pemetrexed for locally advanced or metastatic urothelial cancer; or have received investigational drugs from other clinical trials, chemotherapy, radiotherapy, targeted therapy, or immunotherapy within 4 weeks prior to the first dose; or have received Chinese medicine (herbal medicine) or Chinese patent medicine with anti-tumor indications within 2 weeks prior to the first dose; or have received strong CYP3A4 inhibitors within 2 weeks prior to the first dose or have current requirement of CYP3A4 inhibitors; or had major surgery within 4 weeks prior to the first dose without full recovery or planned surgery within 12 weeks after study treatment.
- 3. Patients with clinical symptoms such as plural, abdominal or pericardial effusion requiring puncture drainage.
- 4. Patients with central nervous system (CNS) metastasis and/or neoplastic meningitis.
- 5. Any severe or uncontrolled systemic diseases. 6. Patients with poorly controlled heart diseases. 7. Evidence of active infections, including but not limited to Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection.
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 | Docetaxel /Paclitaxel /Gemcitabine Hydrochloride /Pemetrexed Disodium Injection |
| Docetaxel InjectionAdministrated intravenously | Drug | MRG002 |
| Paclitaxel InjectionAdministrated intravenously | Drug | MRG002 |
| Gemcitabine Hydrochloride for InjectionAdministrated intravenously | Drug | MRG002 |
| Pemetrexed Disodium InjectionAdministrated intravenously | Drug | MRG002 |
Primary outcome
Overall Survival (OS)
Time frame: Baseline to study completion (up to 36 months)
OS is defined as the time from the date of randomization until death of any cause.
Progression-Free Survival (PFS) by Independent Review Committee (IRC)
Time frame: Baseline to study completion (up to 36 months)
PFS is defined as the duration from the date of randomization to the onset of tumor progression or death of any cause.
10 secondary outcomes
Objective Response Rate (ORR)
Time frame: Baseline to study completion (up to 36 months)
Duration of Response (DoR)
Time frame: Baseline to study completion (up to 36 months)
Disease Control Rate (DCR)
Time frame: Baseline to study completion (up to 36 months)
Clinical Benefit Rate (CBR)
Time frame: Baseline to study completion (up to 36 months)
Time to Response (TTR)
Time frame: Baseline to study completion (up to 36 months)
PFS by investigator
Time frame: Baseline to study completion (up to 36 months)
Adverse Events (AEs)
Time frame: Baseline to 30 days after the last dose of study treatment
Pharmacokinetics (PK) Parameter of MRG002: concentration-time curve
Time frame: Baseline to 7 days after discontinuation of treatment
Anti-drug antibody (ADA)
Time frame: Baseline to 7 days after discontinuation of treatment
Neutralizing antibody (NAb)
Time frame: Baseline to 7 days after discontinuation of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Advanced or Metastatic Urothelium Cancer
Active, not recruitingPhase 1/2
Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction
Advanced Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma
Active, not recruitingPhase 1
Pembrolizumab With Combination Chemotherapy in Treating Participants With Locally Advanced or Metastatic Small Cell/Neuroendocrine Cancers of Urothelium or Prostate
Bladder Small Cell Neuroendocrine Carcinoma, Castration-Resistant Prostate Carcinoma
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.
Aiping Zhou, MD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Fangjian Zhou, MD principal investigator
Sun Yat-sen University Cancer Prevention Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MRG002, Docetaxel Injection and Paclitaxel Injection in people with Advanced or Metastatic Urothelium Cancer, 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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 13 Apr 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Overall Survival (OS) (time frame: Baseline to study completion (up to 36 months)). The study lists 2 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 13 Apr 2023.