Combination TherapyPhase 1/2NCT07432022
A Phase I/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of the EMB-07 Combination Therapy in Patients With Aggressive B-Cell Non-Hodgkin Lymphoma
A Phase 1/2 study testing EMB07 and Rituximab/Gemcitabine/Oxaliplatin in people with Combination Therapy and Aggressive B-Cell Non-Hodgkin Lymphoma, run by Shanghai EpimAb Biotherapeutics Co., Ltd. at 1 site in China.
Trial summary
This is an open-label, multicenter, Phase I/II study designed to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of EMB-07 combination therapy in adult patients with aggressive B-cell non-Hodgkin lymphoma (B-NHL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Combination Therapy, Aggressive B-Cell Non-Hodgkin Lymphoma, EMB07
- What is being tested?
- EMB07 and Rituximab/Gemcitabine/Oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 30 Jun 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Ability to understand and voluntarily sign the Informed Consent Form (ICF);
- Patients aged ≥18 years;
- Life expectancy > 12 weeks;
- ECOG performance status score: ≤1 point during the dose escalation phase, ≤2 points during the dose expansion phase.
- Cohort A: Pathologically confirmed aggressive R/R B-NHL, including DLBCL, not otherwise specified (NOS), or DLBCL transformed from indolent lymphoma (e.g., follicular lymphoma) (t-DLBCL), or other aggressive B-NHL judged to potentially benefit from study treatment by the investigator and sponsor (e.g., high-grade B-cell lymphoma [HGBL], Richter transformation, other large B-cell lymphoma subtypes).
- Cohort B: Newly diagnosed, treatment-naïve DLBCL NOS confirmed by pathology, or t-DLBCL not previously treated with adequate (at least 2 cycles) R-CHOP therapy (excluding Richter transformation or HGBL with BCL2/MYC±BCL6 rearrangements). Patients with newly diagnosed DLBCL NOS should have an International Prognostic Index (IPI) score ≥2 and Ann Arbor stage ≥2. The sponsor will reserve the right to limit the number of t-DLBCL patients enrolled in the study. Other aggressive B-NHLs patients who may benefit from the study treatment can be enrolled after careful risk/benefit assessment by the sponsor and investigator.
Who cannot join
- Current or prior central nervous system (CNS) or meningeal involvement related to the underlying disease.
- Cohort A: Prior exposure to any ROR1-targeted agent (e.g., biologic or CAR-T); or Cohort A1: Prior exposure to Gemcitabine-based chemotherapy (≥ 2 consecutive cycles); or Cohort A2: Prior exposure to Polatuzumab Vedotin; or Cohorts A3 and A4: Refractory to prior Lenalidomide/Zanubrutinib or Chidamide therapy, respectively.
- Contraindications to any agent included in the combination therapy regimen.
- Cohort A: Candidates suitable for ASCT or CAR-T cell therapy.
- Cohort A: Use of any standard or investigational therapy for the underlying disease within 28 days before C1D1 or 5 half-lives (whichever is shorter), including chemotherapy, immunotherapy, radioimmunotherapy, non-palliative radiotherapy, or any other anti-tumor therapy. Only palliative radiotherapy to non-target lesions will be permitted.
- Cohort B: B-NHL with prior receipt of at least 2 consecutive cycles of R-CHOP (prior lymph node biopsy or local radiotherapy will not be an exclusion criterion).
Show all 32Show fewer
- Major surgery or live vaccine administration within 28 days prior to C1D1.
- History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation (except corneal transplantation). In addition, patients who received ASCT within 3 months before C1D1, CAR-T within 6 months before C1D1, or diagnosed with graft-versus-host disease (GVHD) will be excluded.
- Any AE related to prior therapy (excluding alopecia) that has not resolved to Grade ≤ 1 (per the Common Terminology Criteria for Adverse Events [CTCAE], Version 5.0) or baseline at C1D1.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening. Patients with positive HBsAg and/or positive HBcAb but negative HBV DNA will be eligible for enrollment. Patients with positive HCV antibody but negative HCV RNA are also eligible for enrollment.
- Known positive HIV serology or history of active viral infection
- Active infection requiring parenteral antibiotics, antivirals, or antifungals within 14 days before C1D1; prophylactic use of these agents (including parenteral administration) will be permitted.
- Prior malignancy requiring treatment or with evidence of recurrence within 5 years before C1D1 (except non-melanoma skin cancer or adequately treated carcinoma in situ of the cervix). Patients with a history of cancer treated with curative intent > 5 years before C1D1 and no evidence of recurrence will be eligible.
- Ischemic or hemorrhagic stroke of Grade ≥ 3, or gastrointestinal bleeding of Grade ≥ 3, within 6 months before C1D1.
- Active, unstable cardiovascular function:
- Myocardial infarction within 6 months before C1D1;
- Unstable angina within 3 months before C1D1;
- Clinically significant uncontrolled arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes);
- Mobitz type II second-degree or third-degree atrioventricular block;
- Congestive heart failure at class ≥ 3 per New York Heart Association (NYHA)
- Known left ventricular ejection fraction (LVEF) < 50%.
- Known or suspected history of hemophagocytic lymphohistiocytosis (HLH);
- Known history of progressive multifocal leukoencephalopathy;
- Active autoimmune disease requiring treatment
- Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid hormone replacement will be eligible.
- Type 1 diabetes mellitus well-controlled with insulin therapy will be permitted.
- Patients with a history of autoimmune hepatitis, systemic lupus erythematosus, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, granulomatosis with polyangiitis, Sjögren's syndrome, multiple sclerosis, or glomerulonephritis will be excluded.
- Patients with a history of immune thrombocytopenic purpura, autoimmune hemolytic anemia, Guillain-Barré syndrome, myasthenia gravis, myositis, rheumatoid arthritis, vasculitis, or other autoimmune diseases are excluded unless no systemic therapy has been required in the past 12 months.
- Prior systemic immunosuppressive medication (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 28 days before C1D1.
- Systemic corticosteroid use within 2 weeks before study treatment at a dose equivalent to > 10 mg/day Prednisone. Inhaled, topical, or ophthalmic steroids will be permitted. Short-term corticosteroid use (e.g., prophylaxis for intravenous contrast) will be permitted.
- Any other severe underlying medical condition (e.g., active gastric ulcer, uncontrolled seizures, cerebrovascular event, gastrointestinal bleeding, coagulation/thrombotic disorders with severe signs/symptoms, cardiac disease), or psychiatric, psychological, familial, or geographic factors that, in the investigator's judgment, possibly interfere with scheduled disease assessments, treatment, and follow-up, compromise patient compliance, or place the patient at high risk of treatment-related complications.
- Female patients who are pregnant or breastfeeding. Abuse of alcohol, cannabis-derived products, or other controlled substances.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Aerospace Central Hospital
Beijing, Beijing Municipality
Sijia Chen, 86-10-659971775, aschec@163.com
Yuankai Shi
About this study
Official title: A Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EMB-07 (a Bispecific Antibody Targeting CD3 and Receptor-tyrosine-kinase-like Orphan Receptor 1 [ROR1]) Combination Therapy in Patients With Aggressive B-cell Non-Hodgkin Lymphoma
This is an open-label, multicenter, Phase I/II study designed to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of EMB-07 combination therapy in adult patients with aggressive B-cell non-Hodgkin lymphoma (B-NHL). The study consists two phases: Phase I of dose escalation and Phase II of dose expansion. Approximately 115 patients will be enrolled in this study (i.e., 5 cohorts of approximately 23 patients per cohort). Multiple EMB-07-based combination regimens will be evaluated in patients with relapsed/refractory (R/R) aggressive B-NHL (Cohort A) and patients with newly diagnosed aggressive B-NHL (Cohort B).
- Being tested
- EMB07, Rituximab/Gemcitabine/Oxaliplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMB07Drug
EMB-07 is a bispecific antibody targeting CD3 and receptor-tyrosine-kinase-like orphan receptor 1 [ROR1]
Rituximab/Gemcitabine/OxaliplatinDrug
Rituximab is a monoclonal antibody drug specifically targeting the CD20 antigen. Gemcitabine is a chemotherapy drug classified as an antimetabolite. Oxaliplatin is a platinum-based chemotherapy drug.
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Dose Escalation, Phase II: Dose Expansion | Experimental | Phase I: Dose Escalation During the dose escalation, the planned starting dose of EMB-07 is 6 mg. A dose escalation scheme of "3+3" will be followed to determine DLT, MTD, and RP2CD.
Phase II: Dose Expansion For each cohort: During the dose-expansion, approximately 10 to 15 patients will be enrolled and administrated in each cohort to further characterize the safety profile and anti-tumor activity of the combination therapies.
Approximately 20 patients per cohort receiving RP2CD will be pooled from the dose escalation and dose expansion phases to evaluate preliminary efficacy signals. Receives: Drug: EMB07; Drug: Rituximab/Gemcitabine/Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of EMB-07（Phase I only）
Measured: Up to 28 days
Rate of Adverse Events (AE) and Serious Adverse Events (SAE)
Adverse events and serious adverse events as assessed by CTCAE v5.0
Measured: From enrollment up to 30 days after the last dose
Recommended phase II dose (RP2D) of EMB-07
Measured: Up to 28 days
Objective Response Rate (ORR)
Objective response rate, measured by Lugano 2014
Measured: From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
Secondary outcomes (11)
Duration of Response (DOR)
Time from first study drug dose to first documented disease progression (per Lugano 2014 criteria) or death from any cause, whichever occurs first.
Measured: From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years
Duration of Complete Response（DOCR）
Time from first study drug dose to first documented disease progression (per Lugano 2014 criteria) or death from any cause, whichever occurs first.
Measured: From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years
Time to Treatment Response（TTR）
Time from first study drug dose to first documented disease progression (per Lugano 2014 criteria) or death from any cause, whichever occurs first.
Measured: From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years
Time to Complete Response（TTCR）
Time from first study drug dose to first documented disease progression (per Lugano 2014 criteria) or death from any cause, whichever occurs first.
Measured: From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years
Event-Free Survival（EFS）
Time from first study drug dose to first documented disease progression (per Lugano 2014 criteria) or death from any cause, whichever occurs first.
Measured: From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years
Progression Free Survival (PFS)
Time from first study drug dose to first documented disease progression (per Lugano 2014 criteria) or death from any cause, whichever occurs first.
Measured: From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years
Overall Survival（OS）
Time from first study drug dose to first documented disease progression (per Lugano 2014 criteria) or death from any cause, whichever occurs first.
Measured: From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years
Maximum Plasma Concentration (Cmax) of EMB-07
Maximum observed plasma concentration of EMB-07, quantified by a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay using human plasma samples.
Measured: From predose up to 3 months after first dose
Time to Maximum Plasma Concentration (Tmax) of EMB-07
Time from study drug administration to the time of maximum measured plasma concentration of EMB-07, quantified by validated LC-MS/MS assay using human plasma samples.
Measured: From predose up to 30 days after the last dose
Trough Serum Concentration (Ctrough) of EMB-07
Minimum observed serum concentration of EMB-07, measured immediately prior to the next scheduled dose (trough), quantified by validated LC-MS/MS assay using human serum samples.
Measured: From predose up to 30 days after the last dose
Anti-Drug Antibody (ADA) Positive Rate of EMB-07
Percentage of subjects testing positive for anti-EMB-07 binding antibodies in serum samples, detected by a validated electrochemiluminescence (ECL) immunoassay.
Measured: From predose up to 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 posted25 Feb 2026
- Study start1 Apr 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Combination TherapyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai EpimAb Biotherapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432022
- Sponsor's protocol ID
- EMB07X102
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EMB-07 (a Bispecific Antibody Targeting CD3 and Receptor-tyrosine-kinase-like Orphan Receptor 1 [ROR1]) Combination Therapy in Patients With Aggressive B-cell Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT07432022
- Acronym / sponsor ID
- EMB07X102
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Shanghai EpimAb Biotherapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 25 Feb 2026 (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.
This is an open-label, multicenter, Phase I/II study designed to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of EMB-07 combination therapy in adult patients with aggressive B-cell non-Hodgkin lymphoma (B-NHL). The study consists two phases: Phase I of dose escalation and Phase II of dose expansion. Approximately 115 patients will be enrolled in this study (i.e., 5 cohorts of approximately 23 patients per cohort). Multiple EMB-07-based combination regimens will be evaluated in patients with relapsed/refractory (R/R) aggressive B-NHL (Cohort A) and patients with newly diagnosed aggressive B-NHL (Cohort B).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase I: Dose Escalation, Phase II: Dose Expansion | Experimental | Drug: EMB07, Drug: Rituximab/Gemcitabine/OxaliplatinPhase I: Dose Escalation During the dose escalation, the planned starting dose of EMB-07 is 6 mg. A dose escalation scheme of "3+3" will be followed to determine DLT, MTD, and RP2CD. Phase II: Dose Expansion For each cohort: During the dose-expansion, approximately 10 to 15 patients will be enrolled and administrated in each cohort to further characterize the safety profile and anti-tumor activity of the combination therapies. Approximately 20 patients per cohort receiving RP2CD will be pooled from the dose escalation and dose expansion phases to evaluate preliminary efficacy signals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to understand and voluntarily sign the Informed Consent Form (ICF);
- Patients aged ≥18 years;
- Life expectancy > 12 weeks;
- ECOG performance status score: ≤1 point during the dose escalation phase, ≤2 points during the dose expansion phase.
- Cohort A: Pathologically confirmed aggressive R/R B-NHL, including DLBCL, not otherwise specified (NOS), or DLBCL transformed from indolent lymphoma (e.g., follicular lymphoma) (t-DLBCL), or other aggressive B-NHL judged to potentially benefit from study treatment by the investigator and sponsor (e.g., high-grade B-cell lymphoma [HGBL], Richter transformation, other large B-cell lymphoma subtypes).
Key exclusion criteria (32 listed)
- Current or prior central nervous system (CNS) or meningeal involvement related to the underlying disease.
- Cohort A: Prior exposure to any ROR1-targeted agent (e.g., biologic or CAR-T); or Cohort A1: Prior exposure to Gemcitabine-based chemotherapy (≥ 2 consecutive cycles); or Cohort A2: Prior exposure to Polatuzumab Vedotin; or Cohorts A3 and A4: Refractory to prior Lenalidomide/Zanubrutinib or Chidamide therapy, respectively.
- Contraindications to any agent included in the combination therapy regimen.
- Cohort A: Candidates suitable for ASCT or CAR-T cell therapy.
- Cohort A: Use of any standard or investigational therapy for the underlying disease within 28 days before C1D1 or 5 half-lives (whichever is shorter), including chemotherapy, immunotherapy, radioimmunotherapy, non-palliative radiotherapy, or any other anti-tumor therapy. Only palliative radiotherapy to non-target lesions will be permitted.
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 |
|---|---|---|
| EMB07EMB-07 is a bispecific antibody targeting CD3 and receptor-tyrosine-kinase-like orphan receptor 1 [ROR1] | Drug | Phase I: Dose Escalation, Phase II: Dose Expansion |
| Rituximab/Gemcitabine/OxaliplatinRituximab is a monoclonal antibody drug specifically targeting the CD20 antigen. Gemcitabine is a chemotherapy drug classified as an antimetabolite. Oxaliplatin is a platinum-based chemotherapy drug. | Drug | Phase I: Dose Escalation, Phase II: Dose Expansion |
Primary outcome
Maximum tolerated dose (MTD) of EMB-07（Phase I only）
Time frame: Up to 28 days
Rate of Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame: From enrollment up to 30 days after the last dose
Adverse events and serious adverse events as assessed by CTCAE v5.0
Recommended phase II dose (RP2D) of EMB-07
Time frame: Up to 28 days
Objective Response Rate (ORR)
Time frame: From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
Objective response rate, measured by Lugano 2014
11 secondary outcomes
Duration of Response (DOR)
Time frame: From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years
Duration of Complete Response（DOCR）
Time frame: From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years
Time to Treatment Response（TTR）
Time frame: From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years
Time to Complete Response（TTCR）
Time frame: From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years
Event-Free Survival（EFS）
Time frame: From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years
Progression Free Survival (PFS)
Time frame: From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years
Overall Survival（OS）
Time frame: From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years
Maximum Plasma Concentration (Cmax) of EMB-07
Time frame: From predose up to 3 months after first dose
Time to Maximum Plasma Concentration (Tmax) of EMB-07
Time frame: From predose up to 30 days after the last dose
Trough Serum Concentration (Ctrough) of EMB-07
Time frame: From predose up to 30 days after the last dose
Anti-Drug Antibody (ADA) Positive Rate of EMB-07
Time frame: From predose up to 30 days after the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
Related trials for Combination Therapy
Recruiting
MRD-Guided Postoperative Surveillance and Adaptive Treatment for Resectable Lung Cancer
Lung Neoplasms, Neoadjuvant Therapy
Not yet recruitingPhase 3
Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma (Icc)
RecruitingPhase 1
Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, High Grade B-Cell Lymphoma
RecruitingPhase 3
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
Ganglioneuroblastoma, Nodular, Neuroblastoma
RecruitingPhase 2
Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
Lymphoplasmacytic Lymphoma, Waldenstrom Macroglobulinemia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EMB07 and Rituximab/Gemcitabine/Oxaliplatin in people with Combination Therapy and Aggressive B-Cell Non-Hodgkin Lymphoma, run by Shanghai EpimAb Biotherapeutics Co., Ltd. at 1 site in China.
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 6 inclusion and 32 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: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xikang Xu (86-21-61951000, xkxu@epimab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) of EMB-07（Phase I only） (time frame: Up to 28 days). The study lists 4 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 1 Sep 2026.