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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.

MRG002+HX008

Program Director

Suxia Luo, Doctor

Zhenyang Liu, Doctor

Yuping Sun, Doctor

Jin Li, Doctor

Ying yuan, Doctor

Jin Li, MD

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.

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

An Open-label, Multi-center, Phase I/II Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of MRG002 in Combination With HX008 in Patients With HER2-expressed Advanced Malignant Solid Tumors.

DLT is defined as any of the treatment emergent adverse events (TEAE) as specified in the protocol that bear a definite, probable, or possible causal relationship to study drug administration within 28 days after the first dose.

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.

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

ORR is defined as the proportion of subjects with CR and PR according to RECIST v1.1.

DOR is defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause.

DCR is defined as the proportion of subjects achieving CR, PR, and SD after treatment.

PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.

TTR is defined as the time from the start of treatment until the first occurrence of CR or PR by tumor assessment.

OS is defined as the duration from the start of treatment to death of any cause.

Plot of drug concentration changing with time after drug administration.

The proportion of patients with positive ADA results.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of MRG002 in the Treatment of Patients With HER2-expressed Advanced Malignant Solid Tumors.	NCT05338957	Advanced Malign...	MRG002+HX008	18 Years - 75 Years	Shanghai Miracogen Inc.
A Study of MRG002 in the Treatment of Patients With HER2-expressed Advanced Malignant Solid Tumors.	NCT05338957	Advanced Malign...	MRG002+HX008	18 Years - 75 Years	Shanghai Miracogen Inc.

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