Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antibodies

Immunoglobulins

MRG002 will be administrated via intravenous infusion of 2.6 mg/kg once on Day 1 of every 3 weeks (21-day cycle).

MRG002

Program Director

Zefei Jiang, Doctor

Cuizhi Geng, Doctor

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-low locally advanced or metastatic BC.

The study will be conducted in two parts. The first part is efficacy exploration and the second part is efficacy verification. During the course of efficacy exploration, 33 subjects will be enrolled to preliminarily evaluate the safety and efficacy of MRG002. The second part will be adjusted according to the result of the first part. 29 subjects are planned to be enrolled. Considering the dropout rate of 10%, approximately 33 subjects are planned to be enrolled. A total of 66 subjects are planned to be enrolled in efficacy exploration and verification.

A Study of MRG002 in the Treatment of Patients With HER2-low Locally Advanced or Metastatic Breast Cancer (BC)

A Multicenter, Non-randomized, Open-label Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG002 in the Treatment of Patients With HER2-low Locally Advanced or Metastatic Breast Cancer (BC)

ORR was defined as the proportions of subjects with a complete response (CR) and partial response (PR). ORR will be assessed by Independent Review Committee (IRC) according to RECIST v1.1.

ORR was defined as the proportions of subjects with a complete response (CR) and partial response (PR). ORR will be assessed by investigator according to RECIST v1.1.

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

The proportions of subjects surviving without progression from the start of treatment to 6-month and 12-month duration.

TTR was defined as the duration from the start of treatment to the first onset of CR or PR in tumor evaluation.

DOR was 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 was defined as the proportions of subjects achieving CR, PR, and stable disease (SD) after treatment.

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

Incidence of AEs and serious adverse events (SAEs) will be assessed based on NCI-CTCAE v5.0.

Concentration-time curve will be depicted based on pharmacokinetics concentration set (PKCS).

The incidence of anti-drug antibody (ADA) analysis will be summarized for all patients who received at least one cycle study treatment.

Shanghai Miracogen Inc.

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Stomach Neoplasms

Carcinoma, Squamous Cell

Carcinoma, Renal Cell

Lung Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Renal Cell Carcinoma

Stomach Cancer

Ovarian Epithelial Cancer

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

Dostarlimab

GSK4381562

GSK4428859A

US GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Centre

Pamela N. Munster

Antoinette Tan

Debra L. Richardson

Anthony J Olszanski

Reva Elaine Schneider

Drew W Rasco

Vaia Florou

Samantha Bowyer

John Hilton

Lillian Siu

Ye Guo

Francois Ghiringhelli

Loic Lebellec

Toshihiko Doi

Noboru Yamamoto

Dong-Wan Kim

Byoung Chul Cho

Elena Garralda Cabanas

Victor Moreno Garcia

María José de Miguel Luken

Javier García Corbacho

Natalie Cook

Johann S De Bono

GSK Clinical Trials

This is a first time in-human (FTIH) study designed to investigate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of GSK4381562 in participants with select loco-regionally recurrent solid tumors or metastatic solid tumors where curative or standard treatment options have been exhausted.

3 Dose Escalation arms (Arm A: GSK4381562 alone; Arm B: GSK4381562 plus dostarlimab; Arm C: GSK4381562 plus dostarlimab plus GSK4428859A) and 1 new arm, Arm D (dostarlimab plus GSK4428859A). Additional participants may be enrolled in any study arms A, B or C in PK/Pharmacodynamic (PD) cohorts at putative recommended Phase 2 dose (RP2D) level and/or at previously cleared dose levels (up to 15 participants).

First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors

A Phase 1 First-Time-in-Human, Open-Label Study of GSK4381562 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Selected Advanced Solid Tumors

IPD for this study will be made available via the Clinical Study Data Request site.

Number of participants with adverse events leading to permanent discontinuation of study treatment or withdrawal from study by overall frequency will be assessed.

Overall response rate will be calculated as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. It is defined as the percentage of participants with a best overall confirmed complete response (CR) or partial response (PR) at any time as per disease-specific criteria.

GlaxoSmithKline

Anti-Arrhythmia Agents

Vasodilator Agents

Analgesics

Ado-Trastuzumab Emtansine

Trastuzumab

Adenosine

Maytansine

Antineoplastic Agents, Immunological

Tubulin Modulators

Antimitotic Agents

Immunotoxins

Immunoconjugates

Immunologic Factors

Trastuzumab Emtansine for Injection will be administrated via intravenous infusion of 3.6 mg/kg once on Day 1 of every 3 weeks (21-day cycle).

Trastuzumab Emtansine for Injection

Hongyan Ying

Yunjiang Liu, Doctor

Yuanting Gu

Qun Li

Xian Wang

Yunjinang Liu, Doctor

The primary objective of Phase II is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-positive, unresectable locally advanced or metastatic breast cancer. The primary objective of Phase III is to evaluate the efficacy and safety of MRG002 versus Trastuzumab Emtansine (T-DM1) in patients with HER2-positive unresectable locally advanced or metastatic breast cancer who have been previously treated with trastuzumab (or a biosimilar) and an anti-HER2 tyrosine kinase inhibitor (anti-HER2-TKI) and have progressed on or after the most recent therapy.

A Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer

PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause assessed by Independent Review Committee (IRC) according to RECIST v1.1.

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

DoR is defined as the time from first documented objective response (CR/PR) to the first onset of tumor progression or death of any nonsurgical cause.

DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (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.

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

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.

Plot of drug concentration changing with time after drug administration.

The proportion of patients with positive ADA immunogenicity results.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of MRG002 in the Treatment of Patients With HER2-low Locally Advanced or Metastatic Breast Cancer (BC)	NCT04742153	Advanced or Met...	MRG002	18 Years -	Shanghai Miracogen Inc.
First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors	NCT05277051	Neoplasms	GSK4381562 Dostarlimab GSK4428859A	18 Years -	GlaxoSmithKline
A Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer	NCT04924699	Advanced Breast... Metastatic Brea...	MRG002 Trastuzumab Emt...	18 Years - 75 Years	Shanghai Miracogen Inc.

Spots Global Cancer Trial Database for breast cancer (bc)