Neoplasms

Digestive System Diseases

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Stomach Neoplasms

Breast Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

IMM2902 Phase 1a Dose escalation: 0.03, 0.1, 0.25, 0.5, 1.0, 1.5, and 2.0 mg/kg through intravenous administration weekly up to 48 weeks.

Phase 1b Dose expansion: A disease-specific dose expansion study in patients with locally advanced (unresectable) and/or metastatic breast with HER2-overexpression (Cohort 1) or HER2-low (Cohort 2), gastric/esophageal/gastroesophageal junction (GEJ) cancer with HER2-overexpression (Cohort 3) or HER2-low (Cohort 4) and other solid tumors with HER2-overexpression (Cohort 5) is aimed at further defining safety and characterizing efficacy. Dose expansion is through intravenous administration weekly up to 48 weeks.

a recombinant bispecific monoclonal antibody with high affinity to the dual targets, HER2 and CD47

IMM2902

Rachel Qianwen Shao

Frank Xiaodong Gan

Haley

Jala

Cheng Huang, MD

This trial is a first-in-human, open label, multi-center, dose escalation phase 1a study followed by a disease-specific dose expansion phase 1b study to evaluate the safety, efficacy, and pharmacokinetics (PK) of IMM2902, a HER2/SIRPα bispecific mAb-Trap antibody-receptor fusion protein, in patients with HER2-expressing advanced solid tumor.

IMM2902, a HER2/SIRPα Bispecific mAb-Trap Antibody-receptor Fusion Protein, in Patients With HER2-expressing Advanced Solid Tumors

A Phase 1, Open-Label, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of IMM2902 in Patients With HER2-Expressing Advanced Solid Tumors

All toxicities will be graded according to the NCI CTCAE Version 5.0, which provides additional guidance for AEs not specifically mentioned in CTCAE. A DLTs is defined as any Grade 3 or greater AE that is assessed as related to study treatment that occurs during the 4-week DLTs observation period.

Toxicity will be evaluated according to the NCI CTCAE Version 5.0.

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Cholangiocarcinoma

Lung Neoplasms

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Phase 1 is the dose escalation part, patients with HER2 expressing solid tumors will be enrolled in groups of different dose levels, to explore MTD, RP2D, safety, and preliminary efficacy of IMM2902.

Phase 2 is the cohort expansion part, patients with HER2 overexpressing advanced solid tumors will be enrolled in three cohorts, to explore the safety and efficacy of IMM2902.

Dinglu Chen

Jianming Xu

Jiong Wu

This trial is an open-label, multicenter, first-in-human dose-escalation and cohort expansion Phase I/II clinical study to evaluate the safety, tolerability and preliminary efficacy of IMM2902 in the treatment of HER2-expressing advanced solid tumors

IMM2902 in Patients With Advanced Solid Tumors Expressing HER2

An Open-label, Multicenter, First-in-human Dose-escalation and Cohort Expansion Phase I/II Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of IMM2902 in the Treatment of HER2-expressing Advanced Solid Tumors

Observe the safety and tolerability of IMM2902 in patients with advanced solid tumors expressing human epidermal growth factor receptor 2 (HER2), so as to determine the MTD

Observe the safety and tolerability of IMM2902 in patients with advanced solid tumors expressing human epidermal growth factor receptor 2 (HER2), so as to determine the RP2D

proportion of subjects whose tumors achieved CR and PR after treatment

the proportion of subjects whose tumors achieved CR, PR and SD after treatment

the time from the beginning of recording an objective response to the first occurrence of tumor progression, or death from any cause

the time from the start of treatment to tumor progression or death from any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
IMM2902, a HER2/SIRPα Bispecific mAb-Trap Antibody-receptor Fusion Protein, in Patients With HER2-expressing Advanced Solid Tumors	NCT05076591	Advanced Solid ... Advanced Breast... Advanced Gastri...	IMM2902	18 Years -	ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
IMM2902 in Patients With Advanced Solid Tumors Expressing HER2	NCT05805956	Advanced Solid ... Advanced Lung C... Advanced Gastri... Advanced Cholan...	IMM2902	18 Years - 75 Years	ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Spots Global Cancer Trial Database for imm2902

Every month we try and update this database with for imm2902 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for imm2902

Every month we try and update this database with for imm2902 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for imm2902 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.