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

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 290 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-06
• Study Completion Date: 2027-01-31

Brief 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.

Conditions

Advanced or Metastatic Urothelium Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MRG002

MRG002 will be administrated by an IV infusion of 2.2 mg/kg on Day 1 of every 3 weeks (21-day cycle).

Group Type: EXPERIMENTAL

Docetaxel Injection

Intervention Type: DRUG

Administrated intravenously

Paclitaxel Injection

Intervention Type: DRUG

Administrated intravenously

Gemcitabine Hydrochloride for Injection

Intervention Type: DRUG

Administrated intravenously

Pemetrexed Disodium Injection

Intervention Type: DRUG

Administrated intravenously

Docetaxel /Paclitaxel /Gemcitabine Hydrochloride /Pemetrexed Disodium Injection

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).

Group Type: ACTIVE_COMPARATOR

MRG002

Intervention Type: DRUG

Administrated intravenously

Interventions

MRG002

Administrated intravenously

Intervention Type: DRUG

Docetaxel Injection

Administrated intravenously

Intervention Type: DRUG

Paclitaxel Injection

Administrated intravenously

Intervention Type: DRUG

Gemcitabine Hydrochloride for Injection

Administrated intravenously

Intervention Type: DRUG

Pemetrexed Disodium Injection

Administrated intravenously

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Miracogen Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aiping Zhou, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Fangjian Zhou, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University Cancer Prevention Center

Locations

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Program Director

Role: CONTACT

clinicaltrials@miracogen.com.cn

86-21-61637960

Facility Contacts

Aiping Zhou, MD

Role: primary

zhouap1825@126.com

86-10-87788800

Other Identifiers

MRG002-010

Identifier Type: -

Identifier Source: org_study_id