Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Osimertinib

Antibodies

Antibodies, Bispecific

Immunoglobulins

Mitogens

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

In Part 1 dose escalation, patients will receive EMB-01 IV once weekly and osimertinib PO QD on days 1-28. The treatment cycle repeats every 28 days in the absence of disease progression or unacceptable toxicity. Dose escalation will continue until the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) is reached, or all planned doses are administered.

In Part 2 dose expansion, patients will receive EMB-01 IV once weekly and osimertinib PO QD on days 1-28 at the recommended phase II dose (RP2D) regimen. The treatment cycle repeats every 28 days in the absence of disease progression or unacceptable toxicity.

EMB-01 is a bispecific antibody against epidermal growth factor receptor (EGFR) and the receptor tyrosine kinase Met (cMET).

EMB-01

Osimertinib is an approved, third-generation EGFR tyrosine kinase inhibitor

Xiaodong Sun, MD

Di Hu

Misako Nagasaka

Julia Kathleen Rotow

Yi-Long Wu

This phase Ib/II trial studies the side effects and best dose of EMB-01 when given together with osimertinib in patients with EGFR-mutant non-small cell lung cancer that has spread to other places in the body (advanced or metastatic) and has progressed on standard treatment. EMB-01 and osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth in this type of cancer. EMB-01 in combination with osimertinib may work better in treating patients with EGFR-mutant advanced non-small cell lung cancer.

PRIMARY OBJECTIVES:

I. To evaluate the maximum tolerated dose (MTD) and to establish the recommended phase II dose (RP2D) of EMB-01 given in combination with osimertinib in patients with advanced EGFR-mutant non-small cell lung cancer (NSCLC). (Phase Ib)

II. To preliminarily assess efficacy and further evaluate the safety and tolerability of EMB-01 plus osimertinib at the RP2D in advanced EGFR-mutant NSCLC patients who progressed on prior EGFR tyrosine kinase inhibitor (TKI) treatment. The primary endpoint is objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. (Phase II)

SECONDARY OBJECTIVES:

I. To assess the pharmacokinetics (PK) of EMB-01 and osimertinib.

II. To assess the immunogenicity of EMB-01 and osimertinib.

III. To evaluate preliminary antitumor activity of EMB-01 and osimertinib. (Phase I)

IV. To continue to evaluate the antitumor activity of EMB-01 and osimertinib such as progression free survival, best overall response, duration of response, and clinical benefit rate. (Phase II)

EXPLORATORY OBJECTIVES:

I. To explore the relationships between pharmacokinetics, biomarkers, adverse event profiles, and anticancer activity of EMB-01 combined with osimertinib.

OUTLINE: This is a phase Ib, dose-escalation study of EMB-01 and osimertinib followed by a phase II study.

Patients receive EMB-01 intravenously (IV) weekly. Patients also receive osimertinib orally (PO) once daily (QD) on days 1-28. Treatment cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

After the completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.

EMB-01 in Combination With Osimertinib in Patients With EGFR Mutant Lung Cancer

A Phase Ib/II, Open-Label, Multi-Center Study of EMB-01 in Combination With Osimertinib in Patients With Advanced/Metastatic EGFR Mutant Lung Cancer

Adverse events and serious adverse events as assessed by CTCAE v5.0

Objective response rate, measured by RECIST 1.1

Best overall response as assessed by RECIST v1.1

Duration of response as assessed by RECIST v1.1

Clinical benefit rate as assessed by RECIST v1.1

Progression free survival as assessed by RECIST v1.1

Maximum measured plasma concentration of EMB-01

Blood samples will be collected from patients post-treatment for assessment of the presence of anti-drug antibodies and neutralizing antibodies.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
EMB-01 in Combination With Osimertinib in Patients With EGFR Mutant Lung Cancer	NCT05498389	Metastatic Lung... Advanced Lung N... Stage IV Lung C... Stage IVA Lung ... Stage IVB Lung ... Stage III Lung ... Stage IIIA Lung... Stage IIIB Lung... EGFR Mutation-R...	EMB-01 Osimertinib	18 Years -	Shanghai EpimAb Biotherapeutics Co., Ltd.
EMB-01 in Combination With Osimertinib in Patients With EGFR Mutant Lung Cancer	NCT05498389	Metastatic Lung... Advanced Lung N... Stage IV Lung C... Stage IVA Lung ... Stage IVB Lung ... Stage III Lung ... Stage IIIA Lung... Stage IIIB Lung... EGFR Mutation-R...	EMB-01 Osimertinib	18 Years -	Shanghai EpimAb Biotherapeutics Co., Ltd.

Spots Global Cancer Trial Database for emb01

Every month we try and update this database with for emb01 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 emb01

Every month we try and update this database with for emb01 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 emb01 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.