A First-in-human Phase I Study to Evaluate EMB-15 in Patients With Locally Advanced or Metastatic Solid Tumors.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Locally Advanced or Metastatic Solid Tumors
• Intervention / Treatment: Biological: EMB-15

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xi Yang; Phone Number: 86-21-61951000; Email: xyang@epimab.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- 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:

  1. Any prior ALPP/ALPG targeting therapy
  2. Has received anticancer therapy, radiotherapy, or investigational drug within < 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment;
  3. Active autoimmune disease or history of autoimmune disease
  4. Concurrent malignancy < 5 years prior to study entry
  5. active infection
  6. Severe or uncontrolled cardiovascular disease requiring treatment
  7. Other severe medical conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: EMB-15; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of serious adverse events (SAE)	Incidence of SAE.	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.	Screening up to follow-up (30 days after the last dose)
incidence and severity of adverse events as assessed by CTCAE v6.0 and ASTCT.	Incidence and severity of AE.	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.	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.	First infusion to the end of Cycle 1 (each cycle is 28 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the serum concentration-time curve (AUC) of EMB-15	Blood samples for serum PK analysis will be obtained (AUC).	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)	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)	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).	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)	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).	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).	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).	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).	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.	Up to End of Treatment Follow Up Period (30 days after the last dose)

Collaborators and Investigators

• Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 26, 2026
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): October 30, 2029

Study Registration Dates

• First Submitted: May 19, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Phase 1; EMB-15
• Other Study ID Numbers: EMB15X101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No