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Trial Title:
A Study of MRG002 Versus Investigator's Choice of Chemotherapy in the Treatment of Patients With HER2-positive Unresectable Advanced or Metastatic Urothelial Cancer
NCT ID:
NCT05754853
Condition:
Advanced or Metastatic Urothelium Cancer
Conditions: Official terms:
Paclitaxel
Docetaxel
Gemcitabine
Pemetrexed
Conditions: Keywords:
MRG002
Antibody Drug Conjugate (ADC)
HER2
Urothelium Cancer
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
MRG002
Description:
Administrated intravenously
Arm group label:
Docetaxel /Paclitaxel /Gemcitabine Hydrochloride /Pemetrexed Disodium Injection
Intervention type:
Drug
Intervention name:
Docetaxel Injection
Description:
Administrated intravenously
Arm group label:
MRG002
Intervention type:
Drug
Intervention name:
Paclitaxel Injection
Description:
Administrated intravenously
Arm group label:
MRG002
Intervention type:
Drug
Intervention name:
Gemcitabine Hydrochloride for Injection
Description:
Administrated intravenously
Arm group label:
MRG002
Intervention type:
Drug
Intervention name:
Pemetrexed Disodium Injection
Description:
Administrated intravenously
Arm group label:
MRG002
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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Recruiting
Contact:
Last name:
Aiping Zhou, MD
Phone:
86-10-87788800
Email:
zhouap1825@126.com
Start date:
April 6, 2023
Completion date:
January 2027
Lead sponsor:
Agency:
Shanghai Miracogen Inc.
Agency class:
Industry
Source:
Shanghai Miracogen Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05754853
