A Study of MRG002 Versus Investigator's Choice of Chemotherapy in the Treatment of Patients With HER2-positive Unresectable Advanced or Metastatic Urothelial Cancer

NCT05754853 | Recruiting Phase 3 DMC

• 1 other identifier: MRG002-010
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced or Metastatic Urothelium Cancer

Keywords

MRG002; Antibody Drug Conjugate (ADC); HER2; Urothelium Cancer

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS)

  OS is defined as the time from the date of randomization until death of any cause.

  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.

  Baseline to study completion (up to 36 months)

Secondary Outcomes (10)

• Objective Response Rate (ORR)

  Baseline to study completion (up to 36 months)

• Duration of Response (DoR)

  Baseline to study completion (up to 36 months)

• Disease Control Rate (DCR)

  Baseline to study completion (up to 36 months)

• Clinical Benefit Rate (CBR)

  Baseline to study completion (up to 36 months)

• Time to Response (TTR)

  Baseline to study completion (up to 36 months)

Study Arms (2)

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).

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).

Drug: MRG002

Interventions

MRG002 DRUG

Administrated intravenously

Docetaxel /Paclitaxel /Gemcitabine Hydrochloride /Pemetrexed Disodium Injection

Docetaxel Injection DRUG

Administrated intravenously

MRG002

Paclitaxel Injection DRUG

Administrated intravenously

MRG002

Gemcitabine Hydrochloride for Injection DRUG

Administrated intravenously

MRG002

Pemetrexed Disodium Injection DRUG

Administrated intravenously

MRG002

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Willing to sign the ICF and follow the requirements specified in the protocol.
• \. 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.
• \. 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.
• \. Archival or biopsy tumor specimens should be provided (primary or metastatic).
• \. HER2 positive (IHC 3+ or IHC 2+) in the tumor specimens confirmed by central laboratory test.
• \. Patients must have measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
• \. 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).
• \. 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.

You may not qualify if:

• \. History of hypersensitivity to any component of MRG002 or history of hypersensitivity of ≥ Grade 3 to trastuzumab.
• \. 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.
• \. Patients with clinical symptoms such as plural, abdominal or pericardial effusion requiring puncture drainage.
• \. Patients with central nervous system (CNS) metastasis and/or neoplastic meningitis.
• \. 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.
• \. History of other primary malignancies. 9. History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.
• \. 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.
• \. 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.

Sponsors & Collaborators

• Shanghai Miracogen Inc.: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Interventions

Docetaxel; Paclitaxel; Gemcitabine; Injections; Pemetrexed

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Drug Administration Routes; Drug Therapy; Therapeutics; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Aiping Zhou, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Fangjian Zhou, MD

  Sun Yat-sen University Cancer Prevention Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Program Director

CONTACT

86-21-61637960; clinicaltrials@miracogen.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 6, 2023
• Study Start: April 6, 2023
• Primary Completion: October 1, 2025
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)