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

NCT05141747 | Unknown Phase 2

• 1 other identifier: MRG002-007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Locally Advanced Gastric Cancer; Metastatic HER2 Positive Gastroesophageal Junction Cancer

Keywords

MRG002; Antibody Drug Conjugate (ADC); HER2; Gastric/Gastroesophageal Junction Cancer

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR)

  ORR is defined as the percentage of patients with a complete response (CR) and partial response (PR) according to RECIST v1.1.

  Baseline to study completion, up to 24 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.

  Baseline to 45 days after the lase dose of study treatment.

Secondary Outcomes (6)

• Progression Free Survival (PFS)

  Baseline to study completion, up to 24 months.

• Overall Survival (OS)

  Baseline to study completion, up to 24 months.

• Duration of Response (DoR)

  Baseline to study completion, up to 24 months.

• Disease Control Rate (DCR)

  Baseline to study completion, up to 24 months.

• Pharmacokinetics (PK) Parameter of MRG002: concentration-time curve

  Baseline to 30 days after the last dose of study treatment

Study Arms (1)

MRG002

EXPERIMENTAL

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

Drug: MRG002

Interventions

MRG002 DRUG

Administrated intravenously

MRG002

Eligibility Criteria

• Age: 18 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.
• Life expectancy ≥ 3 months.
• Patients with histologically or cytologically confirmed gastric/ gastroesophageal junction cancer.
• 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.
• 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.
• Willing and able to provide adequate archival tumor tissue samples for HER2 status confirmation by central laboratory.
• 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.
• Patients must have at least one measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
• 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.
• Organ function must meet the basic requirements.

You may not qualify if:

• Patients with the following pathological diagnosis: squamous cell carcinoma, carcinoid tumor, neuroendocrine carcinoma, undifferentiated carcinoma, or other unclassifiable gastric cancer.
• Peripheral neuropathy ≥ Grade 2 per CTCAE 5.0.
• Prior treatment with HER2-targeted ADC.
• 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.
• Presence of untreated or uncontrolled central nervous system (CNS) metastases.
• Patients received chemotherapy, biological therapy, radical radiotherapy or other anti-tumor treatment within 3 weeks prior to the first dose of the study drug.
• Any severe cardiac dysfunction, history of myocardial infarction, stroke, or transient ischemic attack (TIA) within 6 months prior to enrollment.
• Pulmonary embolism or deep venous thrombosis within 3 months prior to the first dose of the study drug.
• Tumor lesions with bleeding tendency or treated with blood transfusion within 2 weeks prior to the first dose of the study drug.
• Toxicities due to prior anti-cancer therapy have not resolved to ≤ Grade 1 (CTCAE v5.0).
• Concurrent malignancy within 5 years prior to enrollment.
• Uncontrolled high blood pressure and diabetes.
• History of ventricular tachycardia or torsades de pointes. Any clinically significant abnormalities in rhythm, conduction, or morphology on the resting ECG.
• 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.
• 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.

Sponsors & Collaborators

• Shanghai Miracogen Inc.: lead

Study Sites (3)

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

Beijing, Beijing Municipality, 100000, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410000, China

RECRUITING

Shanghai Oriental Hospital

Shanghai, Shanghai Municipality, 200000, China

NOT YET RECRUITING

Study Officials

• Aiping Zhou, MD

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

  PRINCIPAL INVESTIGATOR

• Jin Li, MD

  Shanghai Oriental Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Program Director

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 2, 2021
• Study Start: January 19, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)