Advanced/Metastatic Solid TumorsPhase 1NCT05607498
First in Human Study of EMB-07 in Locally Advanced/Metastatic Solid Tumors or Relapse/Refractory Lymphoma
A Phase 1 study testing EMB07 in people with Advanced/Metastatic Solid Tumors and Relapse/Refractory Lymphoma, run by EpimAb Biotherapeutics (Suzhou)Co., Ltd. at 10 sites in 2 countries.
Trial summary
For solid tumors and lymphoma, respectively: This study is to evaluate the safety and tolerability of EMB-07 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-07 will also be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced/Metastatic Solid Tumors, Relapse/Refractory Lymphoma
- What is being tested?
- EMB07
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 1 Mar 2023to 31 Mar 2026
- Phase
- Phase 1
- 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
- Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
- Male or female, and aged ≥ 18 years
- Treatment group A: Patients with histologically or cytologically locally advanced unresectable or metastatic solid tumors limiting to triple-negative breast cancer, lung adenocarcinoma, ovarian cancer, pancreatic cancer, colorectal cancer, gastric cancer, prostate cancer, bladder cancer, and uterus cancer. Treatment group B: Patients with histologically or cytologically relapse/refractory lymphoma limiting to chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), mantle cell lymphoma (MCL) and diffuse large B cell lymphoma (DLBCL).
- Treatment group A: Standard therapies do not exist, or are no longer effective, or are not tolerable or accessible to the patient measurable or evaluable disease per RECIST V1.1. Treatment group B: Presence of at least one two-dimensional measurable lesion confirmed by imaging (CT or MRI) (either lymph nodes lesions with any long diameter > 1.5 cm or extranodal lesions with any long diameter > 1.0 cm); for CLL patients whose baseline imaging evaluation determined that no two-dimensional measurable lesions, their peripheral blood monoclonal B lymphocytes should be ≥ 5.0×109/L.
- Patients must provide archival tumor samples, or a biopsy will be required if archival tumor sample is not available. Archival tumor sample must be taken ≤ 2 years prior to screening, otherwise a fresh tumor biopsy at screening is required.
- ECOG performance status 0 or 1
- Adequate organ function to participate in the trial.
- Recovery from adverse events (AEs) related to prior anticancer therapy.
Who cannot join
- Prior treatment with any agent targeting ROR1.
- History of Grade 4 immune-related adverse events (irAEs) or irAEs requiring discontinuation of prior therapies.
- Patient with primary central nervous system (CNS) malignancy or symptomatic CNS metastases. Patients with solid tumors with CNS metastases are eligible if they do not need to receive local radiation treatment at the discretion of investigator or if radiation therapy for CNS metastases is completed ≥ 4 weeks prior to study treatment.
- Anticancer therapy or radiation < 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment.
- Abuse on alcohol, cannabis-derived products, or other drugs.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
China8 sites, 8 recruiting
- Recruiting
Affiliated Hospital of Hebei University
Baoding
Youchao Jia
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Yuankai Shi
- Recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu
Yanli Yang
Huan Zhou
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan
Quchang Ouyang
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou
Sanfang Tu
- Recruiting
The Affiliated Tumour Hospital of Harbin Medical University
Harbin
Qingyuan Zhang
- Recruiting
Shandong Cancer Hospital
Shandong
Zengjun Li
Yuping Sun
- Recruiting
Tianjin Medical University Cancer Institue & Hospital
Tianjin
Lanfang Li
Australia2 sites, 2 recruiting
- Recruiting
Peninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria
Ganju
- Recruiting
One Clinical Research
Nedlands, Western Australia
Ariyapperuma
About this study
Official title: A First-in-human, Phase I, Open-Label Study of EMB-07, a Bi-specific Antibody Anti-CD3 and Receptor Tyrosine Kinase-like Orphan Receptor 1 (ROR1) in Patients With Locally Advanced/Metastatic Solid Tumors or Relapse/Refractory Lymphoma
For solid tumors and lymphoma, respectively: This study is to evaluate the safety and tolerability of EMB-07 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-07 will also be assessed.
Read the detailed description
This is a phase I, multicenter, open label, dose escalation, first in human study, designed to assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose for EMB-07 in patient with locally advanced/metastatic solid tumors or relapse/refractory Lymphoma . Pharmacokinetics, pharmacodynamics, immunogenicity and response will also be assessed.
- Being tested
- EMB07
- Keywords
- Phase I, Bispecific antibody, CD3, ROR1, EMB07, Dose escalation, Advanced/Metastatic Solid Tumors, Relapse/Refractory Lymphoma
- Medical subject headings
- Recurrence, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMB07Drug
EMB07 is a MAT-Fab bispecific antibody against CD3 and RORI
| Study group | Role | What they receive |
|---|---|---|
| EMB-07-Patients with solid tumor | Experimental | Patients with solid tumor will receive intravenous infusions of EMB-07 weekly (QW). Dose escalation will continue until the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is reached or all planned doses are administered. Receives: Drug: EMB07 |
| EMB07-Patients with lymphoma | Experimental | Patients with lymphoma will receive intravenous infusions of EMB-07 weekly (QW). Dose escalation will continue until the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is reached or all planned doses are administered. Receives: Drug: EMB07 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events as assessed by CTCAE V5.0.
Incidence and severity of AE.
Measured: Screening up to 30 days after the last dose.
Incidence of serious adverse events (SAE).
Incidence of SAE.
Measured: Screening up to 30 days after the last dose, or beyond 30 days if SAE is confirmed to be treatment related.
Incidence of dose interruptions.
Incidence of dose interruptions of EMB-07 during treatment as a measure of tolerability.
Measured: Screening up to 30 days after the last dose.
Dose intensity.
Actual amount of drug taken by patients divided by the planned amount.
Measured: Screening up to 30 days after the last dose.
The incidence of DLTs during the first cycle of treatment.
The dose limiting toxicities are based on drug related adverse events and are specifically defined in study protocol.
Measured: First infusion to the end of cycle 1. (each cycle is 28 days).
Secondary outcomes (10)
Overall response rate.
Overall response rate measured by RECIST V1.1, iWCLL-2018, Lugano 2014
Measured: From the date of dosing untill the date of first documented progression or date of death from any casue, whichever case first, expected average 6 months.
Area under the serum concentration-time curve (AUC) of EMB-07.
Blood samples for serum PK analysis will be obtained (AUC).
Measured: Through treatment until EOT visit, expected average 6 months.
Maximum serum concentration (Cmax) of EMB-07.
Blood samples for serum PK analysis will be obtained (Cmax).
Measured: Through treatment until EOT visit, expected average 6 months.
Trough concentration (Ctrough) of EMB-07.
Blood samples for serum PK analysis will be obtained (Ctrough).
Measured: Through treatment until EOT visit, expected average 6 months.
Average concentration over a dosing interval (Css, avg) of EMB-07.
Blood samples for serum PK analysis will be obtained (Css,avg).
Measured: Through treatment until EOT visit, expected average 6 months.
Terminal half-life (T1/2) of EMB-07.
Blood samples for serum PK analysis will be obtained (T1/2).
Measured: Through treatment until EOT visit, expected average 6 months.
Systemic clearance (CL) of EMB-07.
Blood samples for serum PK analysis will be obtained (CL).
Measured: Through treatment until EOT visit, expected average 6 months.
Steady state volume of distribution (Vss) of EMB-07.
Blood samples for serum PK analysis will be obtained (Vss).
Measured: Through treatment until EOT visit, expected average 6 months.
Progression free survival (PFS) of EMB-07 as assessed by RECIST 1.1, iWCLL-2018, Lugano 2014
From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months.
Measured: Through treatment discontinuation: an average of 6 months
Incidence and titer of anti-drug antibodies stimulated by EMB-07.
Antibodies to EMB-07 will be assessed to evaluate potential immunogenicity.
Measured: Up to End of Treatment Follow Up Period (30 days after the last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start1 Mar 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced/Metastatic Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EpimAb Biotherapeutics (Suzhou)Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607498
- Sponsor's protocol ID
- EMB07X101
- Status last verified
- Sep 2024
- First submitted
- 27 Oct 2022
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Phase I, Open-Label Study of EMB-07, a Bi-specific Antibody Anti-CD3 and Receptor Tyrosine Kinase-like Orphan Receptor 1 (ROR1) in Patients With Locally Advanced/Metastatic Solid Tumors or Relapse/Refractory Lymphoma
- ClinicalTrials.gov ID
- NCT05607498
- Acronym / sponsor ID
- EMB07X101
- Keywords
- Phase I, Bispecific antibody, CD3, ROR1, EMB07, Dose escalation, Advanced/Metastatic Solid Tumors, Relapse/Refractory Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- EpimAb Biotherapeutics (Suzhou)Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For solid tumors and lymphoma, respectively: This study is to evaluate the safety and tolerability of EMB-07 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-07 will also be assessed.
Detailed description
This is a phase I, multicenter, open label, dose escalation, first in human study, designed to assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose for EMB-07 in patient with locally advanced/metastatic solid tumors or relapse/refractory Lymphoma . Pharmacokinetics, pharmacodynamics, immunogenicity and response will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMB-07-Patients with solid tumor | Experimental | Drug: EMB07Patients with solid tumor will receive intravenous infusions of EMB-07 weekly (QW). Dose escalation will continue until the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is reached or all planned doses are administered. |
| EMB07-Patients with lymphoma | Experimental | Drug: EMB07Patients with lymphoma will receive intravenous infusions of EMB-07 weekly (QW). Dose escalation will continue until the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is reached or all planned doses are administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
- Male or female, and aged ≥ 18 years
- Treatment group A: Patients with histologically or cytologically locally advanced unresectable or metastatic solid tumors limiting to triple-negative breast cancer, lung adenocarcinoma, ovarian cancer, pancreatic cancer, colorectal cancer, gastric cancer, prostate cancer, bladder cancer, and uterus cancer. Treatment group B: Patients with histologically or cytologically relapse/refractory lymphoma limiting to chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), mantle cell lymphoma (MCL) and diffuse large B cell lymphoma (DLBCL).
- Treatment group A: Standard therapies do not exist, or are no longer effective, or are not tolerable or accessible to the patient measurable or evaluable disease per RECIST V1.1. Treatment group B: Presence of at least one two-dimensional measurable lesion confirmed by imaging (CT or MRI) (either lymph nodes lesions with any long diameter > 1.5 cm or extranodal lesions with any long diameter > 1.0 cm); for CLL patients whose baseline imaging evaluation determined that no two-dimensional measurable lesions, their peripheral blood monoclonal B lymphocytes should be ≥ 5.0×109/L.
- Patients must provide archival tumor samples, or a biopsy will be required if archival tumor sample is not available. Archival tumor sample must be taken ≤ 2 years prior to screening, otherwise a fresh tumor biopsy at screening is required.
Key exclusion criteria (5 listed)
- Prior treatment with any agent targeting ROR1.
- History of Grade 4 immune-related adverse events (irAEs) or irAEs requiring discontinuation of prior therapies.
- Patient with primary central nervous system (CNS) malignancy or symptomatic CNS metastases. Patients with solid tumors with CNS metastases are eligible if they do not need to receive local radiation treatment at the discretion of investigator or if radiation therapy for CNS metastases is completed ≥ 4 weeks prior to study treatment.
- Anticancer therapy or radiation < 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment.
- Abuse on alcohol, cannabis-derived products, or other drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMB07EMB07 is a MAT-Fab bispecific antibody against CD3 and RORI | Drug | EMB-07-Patients with solid tumor, EMB07-Patients with lymphoma |
Primary outcome
Incidence and severity of adverse events as assessed by CTCAE V5.0.
Time frame: Screening up to 30 days after the last dose.
Incidence and severity of AE.
Incidence of serious adverse events (SAE).
Time frame: Screening up to 30 days after the last dose, or beyond 30 days if SAE is confirmed to be treatment related.
Incidence of SAE.
Incidence of dose interruptions.
Time frame: Screening up to 30 days after the last dose.
Incidence of dose interruptions of EMB-07 during treatment as a measure of tolerability.
Dose intensity.
Time frame: Screening up to 30 days after the last dose.
Actual amount of drug taken by patients divided by the planned amount.
The incidence of DLTs during the first cycle of treatment.
Time frame: First infusion to the end of cycle 1. (each cycle is 28 days).
The dose limiting toxicities are based on drug related adverse events and are specifically defined in study protocol.
10 secondary outcomes
Overall response rate.
Time frame: From the date of dosing untill the date of first documented progression or date of death from any casue, whichever case first, expected average 6 months.
Area under the serum concentration-time curve (AUC) of EMB-07.
Time frame: Through treatment until EOT visit, expected average 6 months.
Maximum serum concentration (Cmax) of EMB-07.
Time frame: Through treatment until EOT visit, expected average 6 months.
Trough concentration (Ctrough) of EMB-07.
Time frame: Through treatment until EOT visit, expected average 6 months.
Average concentration over a dosing interval (Css, avg) of EMB-07.
Time frame: Through treatment until EOT visit, expected average 6 months.
Terminal half-life (T1/2) of EMB-07.
Time frame: Through treatment until EOT visit, expected average 6 months.
Systemic clearance (CL) of EMB-07.
Time frame: Through treatment until EOT visit, expected average 6 months.
Steady state volume of distribution (Vss) of EMB-07.
Time frame: Through treatment until EOT visit, expected average 6 months.
Progression free survival (PFS) of EMB-07 as assessed by RECIST 1.1, iWCLL-2018, Lugano 2014
Time frame: Through treatment discontinuation: an average of 6 months
Incidence and titer of anti-drug antibodies stimulated by EMB-07.
Time frame: Up to End of Treatment Follow Up Period (30 days after the last dose)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EMB07 in people with Advanced/Metastatic Solid Tumors and Relapse/Refractory Lymphoma, run by EpimAb Biotherapeutics (Suzhou)Co., Ltd. at 10 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 8 inclusion and 5 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 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China, Australia. 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 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.
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 Sai Lou (+8613758235260, slou@epimab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events as assessed by CTCAE V5.0. (time frame: Screening up to 30 days after the last dose.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.