RECRUITING

A Dose Escalation With Expansion Study of EMB-01 in Participants With Advanced/Metastatic Solid Tumors

Conditions

Neoplasms Neoplasm Metastasis Non-Small-Cell Lung Cancer Human Bispecific antibody,Epidermal Growth Factor Receptor (EGFR),c-Mesenchymal-Epithelial Transition (cMet),Neoplasms, Neoplasm Metastasis,Non-Small-Cell Lung Cancer (NSCLC), First-in-human,EMB-01, Tyrosine Kinase Inhibitor (TKI) Resistant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

First-in-human, Phase I/II, Multicenter, Open-Label Study of EMB-01 in Patients with Advanced/Metastatic Solid Tumors

Official Title

First-in-human, Phase I/II, Multicenter, Open-Label Study of EMB-01 in Patients With Advanced/Metastatic Solid Tumors

Quick Facts

Study Start:2018-12-13

Study Completion:2026-01-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03797391

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. The patient must sign the molecular pre-screening Inform Consent to allow for the molecular pre-screening process. All patients must have documented evidence of EGFR and/or cMet aberrations. 1. Able to understand and willing to sign the Informed Consent Form (ICF). 2. Histologically/cytologically confirmed advanced/metastatic solid tumors with measurable disease \[Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\]: 3. Must have adequate organ function. 4. Regarding prior anti-tumor therapy: 1. Must have stopped treatment at least 4 weeks or within 5 half-lives. 2. Generalized radiation therapy must have stopped 3 weeks before first dose of EMB 01, or local radiotherapy or radiation therapy for bone metastases must have stopped 2 weeks before first dose of EMB-01. No therapeutic radiopharmaceuticals are taken within 8 weeks before first dose of EMB-01. 3. Patients must have recovered to ≤Grade 1 from the adverse effects of such above treatment before beginning study treatment. 5. Female patient with fertility or male patient whose partner has fertility should use one or more contraceptive methods for contraception starting from screening period and continue throughout the study treatment and for 3 months. 6. ECOG score 0 or 1 for phase I, and ≤2 for phase II.	1. Patients who are unwilling to sign the molecular pre-screening ICF. 2. Patients for whom local EGFR and/or cMET data or the results of central laboratory testing do not meet the molecular pre-screening inclusion criteria. 1. Life expectancy \< 3 months. 2. Subject with primacy central nervous system (CNS) malignancy or symptomatic CNS (leptomeningeal or brain) metastases. 3. Pregnant or nursing females. 4. Subjects who have had major surgery within 28 days prior to screening. 5. Serious underlying medical conditions, including but not limited to un-controlled hypertension, other cardiovascular disease or diabetes, ongoing or active infection, psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere the compliance with study treatment.

Inclusion Criteria

Exclusion Criteria

1. The patient must sign the molecular pre-screening Inform Consent to allow for the molecular pre-screening process. All patients must have documented evidence of EGFR and/or cMet aberrations.
1. Able to understand and willing to sign the Informed Consent Form (ICF).
2. Histologically/cytologically confirmed advanced/metastatic solid tumors with measurable disease \[Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\]:
3. Must have adequate organ function.
4. Regarding prior anti-tumor therapy:
1. Must have stopped treatment at least 4 weeks or within 5 half-lives.
2. Generalized radiation therapy must have stopped 3 weeks before first dose of EMB 01, or local radiotherapy or radiation therapy for bone metastases must have stopped 2 weeks before first dose of EMB-01. No therapeutic radiopharmaceuticals are taken within 8 weeks before first dose of EMB-01.
3. Patients must have recovered to ≤Grade 1 from the adverse effects of such above treatment before beginning study treatment.
5. Female patient with fertility or male patient whose partner has fertility should use one or more contraceptive methods for contraception starting from screening period and continue throughout the study treatment and for 3 months.
6. ECOG score 0 or 1 for phase I, and ≤2 for phase II.

1. Patients who are unwilling to sign the molecular pre-screening ICF.
2. Patients for whom local EGFR and/or cMET data or the results of central laboratory testing do not meet the molecular pre-screening inclusion criteria.
1. Life expectancy \< 3 months.
2. Subject with primacy central nervous system (CNS) malignancy or symptomatic CNS (leptomeningeal or brain) metastases.
3. Pregnant or nursing females.
4. Subjects who have had major surgery within 28 days prior to screening.
5. Serious underlying medical conditions, including but not limited to un-controlled hypertension, other cardiovascular disease or diabetes, ongoing or active infection, psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere the compliance with study treatment.

Contacts and Locations

Study Contact

Xiaodong Sun, MD

CONTACT

+86-21-61043299

xdsun@epimab.com

Xuemei Xie

CONTACT

+86-21-61043299

xmxie@epimab.com

Study Locations (Sites)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

Gabrail Cancer Center Research

Canton, Ohio, 44718

United States

Collaborators and Investigators

Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-12-13

Study Completion Date2026-01-15

Study Record Updates

Study Start Date2018-12-13

Study Completion Date2026-01-15

Terms related to this study

Keywords Provided by Researchers

Human Bispecific antibody,
Epidermal Growth Factor Receptor (EGFR),
c-Mesenchymal-Epithelial Transition (cMet),
Neoplasms, Neoplasm Metastasis,
Non-Small-Cell Lung Cancer (NSCLC), First-in-human,
EMB-01, Tyrosine Kinase Inhibitor (TKI) Resistant

Additional Relevant MeSH Terms

Neoplasms
Neoplasm Metastasis
Non-Small-Cell Lung Cancer