A Study of MRG002 in the Treatment of Patients With HER2-positive Advanced Solid Tumors

NCT04941339 | Unknown Phase 1

• 1 other identifier: MRG002-001
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-positive advanced solid tumors.

Conditions

Advanced Solid Tumor

Keywords

MRG002; Antibody Drug Conjugate (ADC); HER2; Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Maximum Tolerated Dose (MTD)

  The highest dose confirmed wherein ≤ 1/6 of patients in a treatment cohort experiences a dose-limiting toxicity (DLT).

  DLT will be evaluated during the first treatment cycle (Day 1-28)

• Recommended Phase II Dose (RP2D)

  The dose level of MRG002 recommended for further clinical studies based on assessment of the safety, efficacy and PK data from this study.

  Baseline to study completion (up to 6 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 49 days after the last dose of study treatment

Secondary Outcomes (8)

• Objective Response Rate (ORR)

  Baseline to study completion (up to 6 months)

• Duration of Response (DoR)

  Baseline to study completion (up to 6 months)

• Progression Free Survival (PFS)

  Baseline to study completion (up to 6 months)

• Pharmacokinetics (PK) parameter of MRG002: Cmax

  Baseline to 21 days after the last dose of study treatment

• Pharmacokinetics (PK) parameter of MRG002: Tmax

  Baseline to 21 days after the last dose of study treatment

Study Arms (1)

MRG002

EXPERIMENTAL

All patients in Phase Ia (dose escalation) and Phase Ib (dose expansion) will be administrated MRG002 on Day 1 of every 3 weeks (21-day cycle).

Drug: MRG002

Interventions

MRG002 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:

• Understands and provides written informed consent and willing to follow the requirements specified in protocol;
• Both genders;
• Aged 18 to 75 (including 18 and 75);
• Expected survival time ≥ 12 weeks;
• Patients with histologically and/or cytologically confirmed HER2-positive solid tumors who have failed standard therapy or for whom no standard therapy exists or for whom standard therapy is not appropriate at current stage;
• Patients must have at least one evaluable lesion (Phase Ia) or measurable lesion (Phase Ib) according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1);
• The score of ECOG for performance status is 0 or 1;
• Prior anti-tumor treatment-related AEs (NCI CTCAE v5.0 Criteria) have recovered to ≤ Grade 1 (except alopecia);
• No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%;
• Organ functions must meet the basic requirements;
• Coagulation function must meet the basic requirements;
• Cumulative anthracycline dose ≤ 360 mg/m2 doxorubicin or its equivalent, 720 mg/m2 epirubicin.

You may not qualify if:

• Received radiotherapy, chemotherapy, biotherapy, immunotherapy, or other anti-tumor drugs within 3 weeks prior to the first dose of MRG002 treatment;
• History of severe cardiac disease;
• Clinically significant abnormalities in rhythm, conduction, and resting ECG morphology;
• Patients with poorly controlled hypertension or clinically significant vascular disease;
• History of moderate to severe dyspnea at rest due to advanced cancer or their complications, severe primary lung disease, or current need of continuous oxygen therapy, or any history of interstitial lung disease (ILD) or pneumonitis;
• Nausea and vomiting of any kind difficult to control, or chronic gastrointestinal disease;
• Patients with symptoms of central nervous system or brain metastasis or received treatment for central nervous system or brain metastasis within 3 months prior to the first dose of MRG002 treatment;
• Major surgery not fully recovery within 4 months prior to the first dose of MRG002 treatment;
• History of hypersensitivity to any component of MRG002 or history of hypersensitivity of ≥ Grade 3 to trastuzumab injection;
• Evidence of active infection of hepatitis B or hepatitis C;
• History of immunodeficiency, including human immunodeficiency virus (HIV) infection, or other immunodeficiency disease, or history of organ transplantation;
• Any serious and/or uncontrolled disease or other condition that, considered by the investigator and sponsor, may compromise the patient's participation in this study;
• Received systemic corticosteroids within 4 weeks prior to the first dose of MRG002 treatment;
• Female patients 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 6 months after the last dose of study treatment.
• Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator.

Sponsors & Collaborators

• Shanghai Miracogen Inc.: lead

Study Sites (1)

Shanghai Oriental Hospital

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

Study Officials

• Jin Li, Doctor

  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 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2021
• First Posted: June 28, 2021
• Study Start: November 21, 2018
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: December 3, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)