A Phase 1 interventional study of EMB-15 in Locally Advanced or Metastatic Solid Tumors, sponsored by Shanghai EpimAb Biotherapeutics Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Shanghai EpimAb Biotherapeutics Co., Ltd. · Phase 1, Interventional, and Treatment
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.
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).
Shanghai EpimAb Biotherapeutics Co., Ltd. is the lead sponsor of 9 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
- 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.
Exclusion Criteria:
Patients meeting any of the following criteria will not be enrolled:
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).
Biological: EMB-15
EMB-15 is a recombinant humanized bi-specific antibody against ALPP/ALPG and CD3
incidence and severity of adverse events as assessed by CTCAE v6.0 and ASTCT.
Incidence and severity of AE.
Time frame: Screening up to follow-up (30 days after the last dose)
Incidence of serious adverse events (SAE)
Incidence of SAE.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: First infusion to the end of Cycle 1 (each cycle is 28 days)
Area under the serum concentration-time curve (AUC) of EMB-15
Blood samples for serum PK analysis will be obtained (AUC).
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
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
Preliminary anti-tumor activity of EMB-15 will be obtained (DOR).
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
Antibodies to EMB-15 will be assessed to evaluate potential immunogenicity.
Time frame: Up to End of Treatment Follow Up Period (30 days after the last dose)
Plan to share: No
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Shanghai EpimAb Biotherapeutics Co., Ltd.