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NeoplasmsPhase 1/2NCT05176665

EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers

A Phase 1/2 study testing EMB-01 in people with Neoplasms and Neoplasm Metastasis, run by Shanghai EpimAb Biotherapeutics Co., Ltd. at 14 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
EMB-01
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
14 sitesin 2 countries
Study dates
21 Oct 2021to 31 Dec 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Molecular Pre-screening Inclusion criteria
  • cMET amplification in tumor sample; OR
  • cMET overexpression in tumor sample; OR
  • EGFR overexpression in tumor sample; OR
  • 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.
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  • Screening Inclusion Criteria
  • Able to understand and willing to sign the Informed Consent Form (ICF).
  • 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:
  • 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.
  • Have measurable disease as defined by RESIST v 1.1.
  • Archival tumor tissue (formalin-fixed or paraffin-embedded, collected within 1 year) or a new biopsy collected in the molecular pre-screening visit.
  • Must have adequate organ function.
  • Regarding prior anti-tumor therapy:
  • 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.
  • 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.
  • 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.
  • 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.
  • ECOG score ≤1.

Who cannot join

  • Molecular Pre-screening Exclusion Criteria
  • Subject who meets any of the following criteria can't be proceeded to clinical screening:
  • Patients who are unwilling to sign the molecular pre-screening ICF.
  • Patients for whom the results of central laboratory testing do not meet the molecular pre-screening inclusion criteria.
  • 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
Show all 11Show fewer
  • Life expectancy < 3 months.
  • 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.
  • Pregnant or nursing females.
  • Patients who have had major surgery within the 28 days from the screening. Surgical wounds must be completely healed.
  • 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.

Trial locations and contacts

14 sites in 2 countries.

Rong Wang, M.Sc contact

+86-21-61043299

CT.info@epimab.com

Di Hu, M.Sc contact

+862161043299

CT.info@epimab.com

14 sites in 2 countries

China13 sites, 13 recruiting

  • Beijing cancer Hospital

    Beijing, Beijing Municipality, 100142

    Lin Shen

    Recruiting

  • Hunan Cancer Hospital

    Changsha

    Shanzhi Gu

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu

    Meng Qiu

    Recruiting

  • Nanfang Hospital

    Guangzhou, Guangdong, 510515

    Yabing Guo

    Recruiting

  • The Sixth Affiliated Hospital of Sun Yat-Sen University

    Guangzhou

    Yanhong Deng

    Recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou

    Hongming Pan

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin

    Yanqiao Zhang

    Recruiting

  • Shandong Cancer Hospital

    Jinan

    Changzheng Li

    Recruiting

  • Gansu Provincial Hospital

    Lanzhou

    Weisheng Zhang

    Recruiting

  • The Affiliated hospital of Qingdao University

    Qingdao

    Zimin Liu

    Not yet recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai

    Zhiyu Chen

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

    Enxiao Li

    Not yet recruiting

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Yanru Qin

    Recruiting

Other trials in China

United States1 site, 1 recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Michael Lee

    Recruiting

Other trials in United States

About this study

Official title: Phase Ib/II, Open-Label Study of EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers

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.

Read the 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.

Being tested
EMB-01
Keywords
Human Bispecific antibody, Epidermal Growth Factor Receptor (EGFR), c-Mesenchymal-Epithelial Transition (cMet), Neoplasms， Neoplasm Metastasis, Neoplasm Metastasis, EMB-01，Tyrosine Kinase Inhibitor (TKI) Resistant
Medical subject headings
Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EMB-01Drug

    Also called FIT-013a

    EMB-01 at the RP2D of 1600 mg will be administered as an IV infusion once weekly (QW) throughout the study. One cycle is defined as 4 weeks (4 doses).

Study groups in NCT05176665
Study groupRoleWhat they receive
Phase Ib and Phase IIExperimentalThe study will consist of Phase Ib and Phase II. The study is planning to recruit approximately 152 patients in total for advanced/metastatic GI cancers, which include 24 patients in Phase Ib and up to approximately 128 patients in Phase II. For GC, HCC, and BTC groups, up to approximately 24 patients may be enrolled in Phase Ib and Phase II. For CRC group, up to approximately 80 patients may be enrolled in Phase Ib and Phase II with up to 40 patients in each subgroup.
Receives: Drug: EMB-01

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0

    Number of participants with Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0

    Measured: Phase 1b, screening up to follow-up (30 days after the last dose)

  2. Best Overall Response (BOR) as assessed by RECIST v1.1

    Best Overall Response (BOR) as assessed by RECIST v1.1

    Measured: Phase II, from the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

  3. Objective Response Rate (ORR) as assessed by RECIST v1.1

    Objective Response Rate (ORR) as assessed by RECIST v1.1

    Measured: Phase II, from the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

  4. Duration of Response (DoR) as assess by RECIST v1.1 as assess by RECIST v1.1

    Duration of Response (DoR) as assess by RECIST v1.1 as assess by RECIST v1.1

    Measured: Phase II, from the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

  5. Disease Control Rate (DCR) as assess by RECIST v1.1

    Disease Control Rate (DCR) as assess by RECIST v1.1

    Measured: Phase II, from the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

  6. Progression-Free Survival (PFS) as assess by RECIST v1.1

    Progression-Free Survival (PFS) as assess by RECIST v1.1

    Measured: Phase II, from the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

  7. Maximum serum concentration (Cmax) of EMB-01

    Maximum serum concentration (Cmax) of EMB-01

    Measured: Phase Ib only, up to 3 months after first study drug administration

  8. Trough serum concentration (Ctrough) of EMB-01

    Trough serum concentration (Ctrough) of EMB-01

    Measured: Phase Ib only, predose, through treatment completion, an average of 1 year

  9. Area under the concentration-time curve from time 0 (pre-dose) to the time of the dosing interval (AUC0-t)

    Area under the concentration-time curve from time 0 (pre-dose) to the time of the dosing interval (AUC0-t)

    Measured: Phase Ib only, up to 3 months after first study drug administration

  10. Area under the concentration-time curve from time 0 to infinity (AUC0-inf)

    Area under the concentration-time curve from time 0 to infinity (AUC0-inf)

    Measured: Phase Ib only, up to 3 months after first study drug administration

  11. Elimination half-life (T1/2)

    Elimination half-life (T1/2)

    Measured: Phase Ib only, up to 3 months after first study drug administration

  12. Systemic clearance (CL)

    Systemic clearance (CL)

    Measured: Phase Ib only, up to 3 months after first study drug administration

  13. Apparent volume of distribution at steady-state (Vss)

    Apparent volume of distribution at steady-state (Vss)

    Measured: Phase Ib only, up to 3 months after first study drug administration

  14. Accumulation Ratio (AR) after multiple dosing

    Accumulation Ratio (AR) after multiple dosing

    Measured: Phase Ib only, up to 3 months after first study drug administration

  15. Incidence of positive ADA

    Incidence of positive ADA

    Measured: Phase Ib only, up to the 30-day safety follow-up visit after EOT

  16. Clinical benefit rate(CBR) as assess by RECIST v1.1

    Clinical benefit rate(CBR) as assess by RECIST v1.1

    Measured: Phase II, from the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Secondary outcomes (10)

  1. Number of participants with Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0

    Number of participants with Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0

    Measured: Phase II, screening up to follow-up (30 days after the last dose)

  2. Maximum serum concentration (Cmax) of EMB-01

    Maximum serum concentration (Cmax) of EMB-01

    Measured: Phase II, up to 3 months after first study drug administration

  3. Trough serum concentration (Ctrough) of EMB-01

    Trough serum concentration (Ctrough) of EMB-01

    Measured: Phase II, predose, through treatment completion, an average of 1 year

  4. Incidence of positive ADA

    Incidence of positive ADA

    Measured: Phase II , up to the 30-day safety follow-up visit after EOT

  5. Best Overall Response (BOR) as assessed by RECIST v1.1

    Best Overall Response (BOR) as assessed by RECIST v1.1

    Measured: Phase Ib, from the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

  6. Objective Response Rate (ORR) as assessed by RECIST v1.1

    Objective Response Rate (ORR) as assessed by RECIST v1.1

    Measured: Phase Ib, from the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

  7. Duration of Response (DoR) as assess by RECIST v1.1 as assess by RECIST v1.1

    Duration of Response (DoR) as assess by RECIST v1.1 as assess by RECIST v1.1

    Measured: Phase Ib, from the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

  8. Disease Control Rate (DCR) as assess by RECIST v1.1

    Disease Control Rate (DCR) as assess by RECIST v1.1

    Measured: Phase Ib, from the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

  9. Progression-Free Survival (PFS) as assess by RECIST v1.1

    Progression-Free Survival (PFS) as assess by RECIST v1.1

    Measured: Phase Ib, from the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

  10. Clinical benefit rate(CBR) as assess by RECIST v1.1

    Clinical benefit rate(CBR) as assess by RECIST v1.1

    Measured: Phase Ib, from the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2022
  2. Study start21 Oct 2021
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
152 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05176665
Sponsor's protocol ID
EMB01X201
Status last verified
Aug 2024
First submitted
3 Nov 2021
Last updated
26 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing EMB-01 in people with Neoplasms and Neoplasm Metastasis, run by Shanghai EpimAb Biotherapeutics Co., Ltd. at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rong Wang, M.Sc (+86-21-61043299, CT.info@epimab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0 (time frame: Phase 1b, screening up to follow-up (30 days after the last dose)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05176665.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.

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