A Study of MRG002 in the Treatment of HER2-positive/HER2-low Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Cancer.

NCT ID: NCT05141747

Last Updated: 2022-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-19
• Study Completion Date: 2023-12-31

Brief Summary

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 as single agent in patients with HER2-positive /HER2-low locally advanced or metastatic gastric/ gastroesophageal junction cancer.

Detailed Description

There are two cohorts in this study. HER2-positive and HER2-low patients will be allocated to cohort 1 and cohort 2, respectively. When the 20th, 40th, or 60th patient in each cohort completed at least one post-baseline tumor assessment, the Safety Monitoring Committee will review the safety and efficacy of these patients to determine dose selection, enrollment continuation, study population, and sample size.

Conditions

Locally Advanced Gastric Cancer; Metastatic HER2 Positive Gastroesophageal Junction Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MRG002

MRG002 will be administrated by an IV infusion of 2.6 mg/kg on Day 1 of every 3 weeks (21-day cycle).

Group Type: EXPERIMENTAL

MRG002

Intervention Type: DRUG

Administrated intravenously

Interventions

MRG002

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.

3. Life expectancy ≥ 3 months.

4. Patients with histologically or cytologically confirmed gastric/ gastroesophageal junction cancer.

5. In Cohort 1, a positive HER2 test result defined as follows: IHC 3+ or IHC 2+ and ISH positive. In Cohort 2, low HER2 expression defined as follows: IHC 1+, or IHC 2+ and ISH negative.

6. Documented tumor progression or intolerance during or after at least one prior line of platinum- and/or fluoropyrimidine-based chemotherapy ± anti-HER2 (trastuzumab or equivalent) therapy.

7. Willing and able to provide adequate archival tumor tissue samples for HER2 status confirmation by central laboratory.

8. Cohort 1 patients, who have received prior anti-HER2 therapy, are willing to undergo fresh tissue biopsy to confirm HER2 status as assessed by the investigator to be feasible and safe.

9. Patients must have at least one measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

10. The score of ECOG for performance status is 0 or 1 with no deterioration within 2 weeks prior to the first dose of the study drug.

11. Organ function must meet the basic requirements.

Exclusion Criteria

1. Patients with the following pathological diagnosis: squamous cell carcinoma, carcinoid tumor, neuroendocrine carcinoma, undifferentiated carcinoma, or other unclassifiable gastric cancer.

2. Peripheral neuropathy ≥ Grade 2 per CTCAE 5.0.

3. Prior treatment with HER2-targeted ADC.

4. Known allergic reaction to any component or excipient of MRG002, or known allergic reaction to trastuzumab or other prior anti-HER2 or other monoclonal antibodies ≥ Grade 3.

5. Presence of untreated or uncontrolled central nervous system (CNS) metastases.

6. Patients received chemotherapy, biological therapy, radical radiotherapy or other anti-tumor treatment within 3 weeks prior to the first dose of the study drug.

7. Any severe cardiac dysfunction, history of myocardial infarction, stroke, or transient ischemic attack (TIA) within 6 months prior to enrollment.

8. Pulmonary embolism or deep venous thrombosis within 3 months prior to the first dose of the study drug.

9. Tumor lesions with bleeding tendency or treated with blood transfusion within 2 weeks prior to the first dose of the study drug.

10. Toxicities due to prior anti-cancer therapy have not resolved to ≤ Grade 1 (CTCAE v5.0).

11. Concurrent malignancy within 5 years prior to enrollment.

12. Uncontrolled high blood pressure and diabetes.

13. History of ventricular tachycardia or torsades de pointes. Any clinically significant abnormalities in rhythm, conduction, or morphology on the resting ECG.

14. History of moderate to severe dyspnea at rest due to advanced cancer or its complications, severe primary lung disease, current need for continuous oxygen therapy, or clinically active interstitial lung disease (ILD) or pneumonitis.

15. Patients who had undergone thoracotomy, laparotomy, or surgery requiring general anesthesia without complete recovery within 4 weeks prior to the first dose of the study drug.

16. Active hepatitis B, active hepatitis C, syphilis or human immunodeficiency virus (HIV) infection.

17. Active uncontrolled bacterial, viral, fungal, rickettsial, or parasitic infection requiring intravenous anti-infective therapy within 2 weeks prior to the first dose of study drug.

18. Any severe and/or uncontrolled systemic diseases.

19. Use of systemic corticosteroids within 4 weeks prior to the first dose of study drug.

20. Use of potent CYP3A4 inhibitors or potent CYP3A4 inducers within 2 weeks prior to the first dose of study drug or need to continue during the study.

21. Female patents 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 180 days after the last dose of study treatment.

22. Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator.

• Minimum Eligible Age: 18 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 Hospital Chinese Academy of Medical Sciences and Peking Union Medical College

Jin Li, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Oriental Hospital

Locations

Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

Site Status: NOT_YET_RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

Site Status: RECRUITING

Shanghai Oriental Hospital

Shanghai, Shanghai Municipality, China

Site Status: NOT_YET_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

Zhenyang Liu

Role: primary

liuzhenyang@hnca.org.cn

18673181133

Jin Li, MD

Role: primary

lijin@csco.org.cn

021-3880-4518

Other Identifiers

MRG002-007

Identifier Type: -

Identifier Source: org_study_id