Locally Advanced or Metastatic Solid TumorsPhase 1NCT07607054
A First-in-human Phase I Study to Evaluate EMB-15 in Patients With Locally Advanced or Metastatic Solid Tumors.
A Phase 1 study testing EMB-15 in people with Locally Advanced or Metastatic Solid Tumors, run by Shanghai EpimAb Biotherapeutics Co., Ltd. at 1 site in China.
Trial summary
The primary purpose of this study is to evaluate safety and tolerability profile of EMB-15, identify the recommended Phase 2 dose(s) (RP2Ds) for EMB-15. Pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and the anti-tumor activity of EMB-15 will also be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Solid Tumors
- What is being tested?
- EMB-15
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2026to 30 Oct 2029
- Phase
- Phase 1
- 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
- 1) Able to understand and willing to sign an ICF 2) Males or females with the age ≥ 18 years 3) Life expectancy > 3 months. 4) ECOG performance status 0 or 1 5) Patients must have histologically or cytologically confirmed locally advanced or metastatic solid tumors, without standard therapy.
- 6) Patients must provide archived tumor samples collected within 1 year. 7) Adequate hematological and organ function.
Who cannot join
- Patients meeting any of the following criteria will not be enrolled:
- Any prior ALPP/ALPG targeting therapy
- Has received anticancer therapy, radiotherapy, or investigational drug within < 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment;
- Active autoimmune disease or history of autoimmune disease
- Concurrent malignancy < 5 years prior to study entry
- active infection
- Severe or uncontrolled cardiovascular disease requiring treatment
- Other severe medical conditions
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
Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
Mingfei Zhang, 86-21-61951000, mfzhang@epimab.com
About this study
Official title: A First-in-Human, Phase I, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Antitumor Activity of EMB-15 in Patients With Locally Advanced or Metastatic Solid Tumors
The primary purpose of this study is to evaluate safety and tolerability profile of EMB-15, identify the recommended Phase 2 dose(s) (RP2Ds) for EMB-15. Pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and the anti-tumor activity of EMB-15 will also be assessed.
Read the detailed description
This is a first-in-human (FIH), open-label, Phase I, multicenter dose escalation study to identify the RP2D and to evaluate the safety, tolerability, pharmacokinetics, and antitumor activities of EMB-15 in adult patients with locally advanced/metastatic solid tumors who have progressed on available standard of care or for which no standard therapy exists.This is an open-label, non-randomized dose-escalation study comprising a dose-escalation phase and a dose-expansion phase. It's planned to recruit approximately 50 patients (the final number will be determined depending on the number of dose levels) with locally advanced or metastatic solid tumors. The trial consists of a screening period (Day -28 to Day -1), a step-up dose period (applicable only to doses with higher CRS risk, lasting 7 days or longer), a treatment period (28 days per cycle, up to 2 years), and a safety follow-up period (30 days after the last dose).
- Being tested
- EMB-15
- Keywords
- Phase 1, EMB-15
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMB-15Biological
EMB-15 is a recombinant humanized bi-specific antibody against ALPP/ALPG and CD3
| Study group | Role | What they receive |
|---|---|---|
| EMB-15 | Experimental | This is an open-label, non-randomized dose-escalation study comprising a dose-escalation phase and a dose-expansion phase. It's planned to recruit approximately 50 patients (the final number will be determined depending on the number of dose levels) with locally advanced or metastatic solid tumors. The trial consists of a screening period (Day -28 to Day -1), a step-up dose period (applicable only to doses with higher CRS risk, lasting 7 days or longer), a treatment period (28 days per cycle, up to 2 years), and a safety follow-up period (30 days after the last dose). Receives: Biological: EMB-15 |
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 v6.0 and ASTCT.
Incidence and severity of AE.
Measured: Screening up to follow-up (30 days after the last dose)
Incidence of serious adverse events (SAE)
Incidence of SAE.
Measured: Screening up to follow-up (30 days after the last dose)
Incidence of dose interruptions
Incidence of dose interruptions of EMB-15 during treatment as a measure of tolerability.
Measured: Screening up to follow-up (30 days after the last dose)
Dose intensity
Actual amount of drug taken by patients divided by the planned amount.
Measured: Screening up to follow-up (30 days after the last dose)
The incidence of DLTs during the DLT evaluation period.
The Dose Limiting Toxicities (DLTs) 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)
Area under the serum concentration-time curve (AUC) of EMB-15
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-15
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-15
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-15
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-15
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-15
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-15
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-15 as assessed by RECIST 1.1
Preliminary anti-tumor activity of EMB-15 will be obtained (PFS).
Measured: 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
Duration of response of EMB-15 as assessed by RECIST 1.1
Preliminary anti-tumor activity of EMB-15 will be obtained (DOR).
Measured: 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
Incidence and titer of anti-drug antibodies stimulated by EMB-15
Antibodies to EMB-15 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 posted26 May 2026
- Study start26 May 2026 (estimated)
- Primary completion31 May 2029 (estimated)
- Study completion30 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT07607054
- Sponsor's protocol ID
- EMB15X101
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 15 Jun 2026
- Results posted
- 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 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Phase I, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Antitumor Activity of EMB-15 in Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07607054
- Acronym / sponsor ID
- EMB15X101
- Keywords
- Phase 1, EMB-15
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai EpimAb Biotherapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 May 2026 (estimated)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 30 Oct 2029 (estimated)
- First posted
- 26 May 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.
The primary purpose of this study is to evaluate safety and tolerability profile of EMB-15, identify the recommended Phase 2 dose(s) (RP2Ds) for EMB-15. Pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and the anti-tumor activity of EMB-15 will also be assessed.
Detailed description
This is a first-in-human (FIH), open-label, Phase I, multicenter dose escalation study to identify the RP2D and to evaluate the safety, tolerability, pharmacokinetics, and antitumor activities of EMB-15 in adult patients with locally advanced/metastatic solid tumors who have progressed on available standard of care or for which no standard therapy exists.This is an open-label, non-randomized dose-escalation study comprising a dose-escalation phase and a dose-expansion phase. It's planned to recruit approximately 50 patients (the final number will be determined depending on the number of dose levels) with locally advanced or metastatic solid tumors. The trial consists of a screening period (Day -28 to Day -1), a step-up dose period (applicable only to doses with higher CRS risk, lasting 7 days or longer), a treatment period (28 days per cycle, up to 2 years), and a safety follow-up period (30 days after the last dose).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMB-15 | Experimental | Biological: EMB-15This is an open-label, non-randomized dose-escalation study comprising a dose-escalation phase and a dose-expansion phase. It's planned to recruit approximately 50 patients (the final number will be determined depending on the number of dose levels) with locally advanced or metastatic solid tumors. The trial consists of a screening period (Day -28 to Day -1), a step-up dose period (applicable only to doses with higher CRS risk, lasting 7 days or longer), a treatment period (28 days per cycle, up to 2 years), and a safety follow-up period (30 days after the last dose). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1) Able to understand and willing to sign an ICF 2) Males or females with the age ≥ 18 years 3) Life expectancy > 3 months. 4) ECOG performance status 0 or 1 5) Patients must have histologically or cytologically confirmed locally advanced or metastatic solid tumors, without standard therapy.
- 6) Patients must provide archived tumor samples collected within 1 year. 7) Adequate hematological and organ function.
Key exclusion criteria (8 listed)
- Patients meeting any of the following criteria will not be enrolled:
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 |
|---|---|---|
| EMB-15EMB-15 is a recombinant humanized bi-specific antibody against ALPP/ALPG and CD3 | Biological | EMB-15 |
Primary outcome
incidence and severity of adverse events as assessed by CTCAE v6.0 and ASTCT.
Time frame: Screening up to follow-up (30 days after the last dose)
Incidence and severity of AE.
Incidence of serious adverse events (SAE)
Time frame: Screening up to follow-up (30 days after the last dose)
Incidence of SAE.
Incidence of dose interruptions
Time frame: Screening up to follow-up (30 days after the last dose)
Incidence of dose interruptions of EMB-15 during treatment as a measure of tolerability.
Dose intensity
Time frame: Screening up to follow-up (30 days after the last dose)
Actual amount of drug taken by patients divided by the planned amount.
The incidence of DLTs during the DLT evaluation period.
Time frame: First infusion to the end of Cycle 1 (each cycle is 28 days)
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and are specifically defined in study protocol.
10 secondary outcomes
Area under the serum concentration-time curve (AUC) of EMB-15
Time frame: Through treatment until EOT visit, expected average 6 months
Maximum serum concentration (Cmax) of EMB-15
Time frame: Through treatment until EOT visit, expected average 6 months
Trough concentration (Ctrough) of EMB-15
Time frame: Through treatment until EOT visit, expected average 6 months
Average concentration over a dosing interval (Css, avg)of EMB-15
Time frame: Through treatment until EOT visit, expected average 6 months
Terminal half-life (T1/2) of EMB-15
Time frame: Through treatment until EOT visit, expected average 6 months.
Systemic clearance (CL) of EMB-15
Time frame: Through treatment until EOT visit, expected average 6 months.
Steady state volume of distribution (Vss) of EMB-15
Time frame: Through treatment until EOT visit, expected average 6 months
Progression free survival (PFS) of EMB-15 as assessed by RECIST 1.1
Time frame: 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
Duration of response of EMB-15 as assessed by RECIST 1.1
Time frame: 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
Incidence and titer of anti-drug antibodies stimulated by EMB-15
Time frame: Up to End of Treatment Follow Up Period (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 15 Jun 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EMB-15 in people with Locally Advanced or Metastatic Solid Tumors, 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 2 inclusion and 8 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 15 Jun 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 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?
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 Xi Yang (86-21-61951000, xyang@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 v6.0 and ASTCT. (time frame: Screening up to follow-up (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 15 Jun 2026.