A Study of MRG002 in the Treatment of Patients With HER2-expressed Advanced Malignant Solid Tumors.

NCT ID: NCT05338957

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-05
• Study Completion Date: 2024-12-31

Brief Summary

The objective of this study is to assess the safety and tolerability of MRG002 in combination with HX008 in patients with HER2-expressed advanced malignant solid tumors; and to , explore the maximum tolerated dose (MTD), and to determine the recommended phase II dose (RP2D) of combination therapy; , and to evaluate the preliminary efficacy, pharmacokinetics, and immunogenicity of combination therapy in the targeted study population.

Conditions

Advanced Malignant Solid Tumors

Study Design

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

Study Groups

MRG002+HX008

MRG002 will be administrated via intravenous infusion at 1.8，,2.2, or 2.6 mg/kg , (if appropriate) once on Day 1 of every 3 weeks (21-day cycle), up to 24 months.

HX008 will be administrated via intravenous infusion at 3 mg/kg once on Day 1 of every 3 weeks (21-day- cycle), up to 24 months.

Group Type: EXPERIMENTAL

MRG002+HX008

Intervention Type: DRUG

Administrated intravenously

Interventions

MRG002+HX008

Administrated intravenously

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Willing to sign the informed consent form and follow the requirements specified in the protocol.

2. Aged 18 to 75 (including 18 and 75), both genders.

3. Life expectancy ≥ 12 weeks.

4. Patients with histopathological or cytological confirmed HER2-expressed advanced solid tumors, and with at least one measurable lesion according to the Response Criteria in Solid Tumors (RECIST v1.1).

5. The score of ECOG for performance status is 0 or 1.

6. The toxicity of previous anti-tumor treatment has recovered to ≤ Grade 1 as defined by NCI-CTCAEv5.0.

7. No severe cardiac dysfunction.

8. Organ functions must meet the basic requirements.

9. Cumulative dose of anthracycline ≤ 450 mg/m2 doxorubicin or its equivalent.

Exclusion Criteria

1. Prior treatment with chemotherapy, biological therapy, immunotherapy, radiotherapy, investigational drugs, attenuated live vaccines, immunomodulators, CYP3A4 inhibitors/inducers, antibody-drug conjugates, etc.

2. Treatment with immune checkpoint inhibitors or tumor vaccines within 60 days prior to the first dose.

3. Treatment with systemic corticosteroids or other immunosuppressive drugs within 14 days prior to the first dose or during the study period.

4. History of severe cardiac disease.

5. Poorly controlled hypertension and hyperglycemia.

6. Presence of peripheral neuropathy ≥ Grade 2.

7. History of moderate or severe dyspnea at rest due to advanced malignant tumor or its complications or severe primary pulmonary disease, or current need of continuous oxygen therapy, or current interstitial lung disease or pneumonia.

8. Central nervous system metastasis.

9. Received major surgery within 4 weeks prior to the first dose without complete recovery.

10. History of hypersensitivity to any component of MRG002 or HX008 or known history of hypersensitivity of ≥ Grade 3 to macromolecular protein products/monoclonal antibodies.

11. Evidence of active infection.

12. History of primary immunodeficiency or autoimmune disease.

13. 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.

14. Previous history of other primary malignancies.

15. Other conditions inappropriate for participation in this study, as deemed by 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

Jin Li, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Oriental Hospital

Locations

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status: RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

Site Status: RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, China

Site Status: RECRUITING

Shanghai Oriental Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Program Director

Role: CONTACT

clinicaltrials@miracogen.com.cn

86-21-61637960

Facility Contacts

Suxia Luo, Doctor

Role: primary

Zhenyang Liu, Doctor

Role: primary

Yuping Sun, Doctor

Role: primary

Jin Li, Doctor

Role: primary

lijin@csco.org.cn

021-38804518

Ying yuan, Doctor

Role: primary

Other Identifiers

MRG002/HX008-C001

Identifier Type: -

Identifier Source: org_study_id