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NCT05176665 | RECRUITING | Neoplasms

EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers
Sponsor:

Shanghai -Tipmab Biotherputics., Ltd.

Brief Summary:

This study is to evaluate the safety and antitumor activity of EMB-01 in advanced/metastatic gastrointestinal cancers, including gastric cancer, hepatocellular cancer, cholangiocarcinoma and colorectal cancer.

Condition or disease

Neoplasms

Neoplasm Metastasis

Metastatic Gastrointestinal Carcinoid Tumor

Intervention/treatment

EMB-01

Phase

PHASE1

PHASE2

Detailed Description:

This is an open-label, Phase Ib/II, multi-stage study of EMB-01 in patients with advanced gastrointestinal tumors including gastric cancer, hepatocellular cancer, cholangiocarcinoma cancer and colorectal cancer, who have EGFR/cMET gene alterations or protein over expression and progressed on available standard therapies and for whom no standard therapy exists that would confer clinical benefit. All patients will be prescreened for cMET and EGFR genetic alterations and protein expression. Only those who met the molecular pre-screening criteria will proceed to clinical screening to determine the eligibility. The study will consist of Phase Ib part and Phase II part, both phases will consist of a molecular prescreening period, screening period, treatment period, safety follow-up period, and disease progression follow-up.

Study Type : INTERVENTIONAL
Estimated Enrollment : 152 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Phase Ib/II, Open-Label Study of EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers
Actual Study Start Date : 2021-10-21
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • Molecular Pre-screening Inclusion criteria
  • 1. cMET amplification in tumor sample; OR
  • 2. cMET overexpression in tumor sample; OR
  • 3. EGFR overexpression in tumor sample; OR
  • 4. Other EGFR or cMET gene alteration in blood sample (circulating tumor DNA, ctDNA).
  • In Phase II, CRC patients must provide blood sample for NGS test, but may not provide tumor samples at prescreening visit. CRC patients don't need to meet the above criteria of EGFR/cMET amplification, overexpression or gene aberration.
  • Screening Inclusion Criteria
  • 1. Able to understand and willing to sign the Informed Consent Form (ICF).
  • 2. Histologically/cytologically confirmed advanced/metastatic gastric cancer, HCC, BTC, and colorectal cancer with measurable disease (RECIST V1.1). To be eligible, patients must meet following criteria
    • 1. Have failed all standard of care therapies known to confer clinical benefit. Patients who is not tolerable on standard of care therapies, or no standard of care therapies available, or refused standard of care therapies are eligible.
    • 2. Have measurable disease as defined by RESIST v 1.1.
    • 3. Archival tumor tissue (formalin-fixed or paraffin-embedded, collected within 1 year) or a new biopsy collected in the molecular pre-screening visit.
    • 4. Must have adequate organ function.
    • 5. Regarding prior anti-tumor therapy
      • 1. Patients who have received any anticancer drugs approved or investigational, including chemotherapy, immune therapy, hormonal therapy (Exceptions: hormone-replacement therapy, testosterone or oral contraceptives), biologic therapy, must have stopped treatment at least 4 weeks or within 5 half -lives whichever shorter before first dose of EMB-01.
      • 2. 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 who have received prior targeted therapies must have stopped treatment for at least 4 weeks or within 5 half-lives, whichever is shorter before first dose of EMB-01.
      • 6. 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.
      • 7. ECOG score ≤1.
      Exclusion Criteria
      • Molecular Pre-screening Exclusion Criteria
      • Subject who meets any of the following criteria can't be proceeded to clinical screening
        • 1. Patients who are unwilling to sign the molecular pre-screening ICF.
        • 2. Patients for whom the results of central laboratory testing do not meet the molecular pre-screening inclusion criteria.
        • 3. Patients with a documented gene alteration including but not limited to HER2, KRAS, NRAS, BRAF, NTRK, ALK, RET, ROS1, and FGFR, etc. that is known to confer resistance to EGFR and/or cMET inhibitors.\* \* In Phase II, CRC patients with activated KRAS, NRAS or BRAF mutation should be excluded, but patients with other gene alterations do not need to be excluded.
        • Screening Exclusion Criteria
        • 1. Life expectancy \< 3 months.
        • 2. Patients with primary central nervous system (CNS) malignancy or symptomatic CNS (leptomeningeal or brain) metastases are not allowed. Patients with asymptomatic CNS metastases are eligible.
        • 3. Pregnant or nursing females.
        • 4. Patients who have had major surgery within the 28 days from the screening. Surgical wounds must be completely healed.
        • 5. Any other serious underlying medical (e.g. uncontrolled diabetes mellitus, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, cardiac conditions), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers

Location Details

NCT05176665

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

China, Beijing

Beijing cancer Hospital

Beijing, Beijing, China, 100142

RECRUITING

China, Guangdong

Nanfang Hospital

Guangzhou, Guangdong, China, 510515

RECRUITING

China,

Hunan Cancer Hospital

Changsha, China,

RECRUITING

China,

West China Hospital, Sichuan University

Chengdu, China,

RECRUITING

China,

The Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, China,

RECRUITING

China,

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, China,

RECRUITING

China,

Harbin Medical University Cancer Hospital

Harbin, China,

RECRUITING

China,

Shandong Cancer Hospital

Women, China,

RECRUITING

China,

Gansu Provincial Hospital

Lanzhou, China,

NOT YET RECRUITING

China,

The Affiliated hospital of Qingdao University

Qingdao, China,

RECRUITING

China,

Fudan University Shanghai Cancer Center

Shanghai, China,

NOT YET RECRUITING

China,

The First Affiliated Hospital of Xi'an Jiaotong University

XI'an, China,

RECRUITING

China,

First Affiliated Hospital of Zhengzhou University

Zhengzhou, China,