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

NCT07607054 | Recruiting Phase 1

• 1 other identifier: EMB15X101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Locally Advanced or Metastatic Solid Tumors

Keywords

Phase 1; EMB-15

Outcome Measures

Primary Outcomes (5)

• 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 serious adverse events (SAE)

  Incidence of SAE.

  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)

• 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)

• 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 Outcomes (10)

• Area under the serum concentration-time curve (AUC) of EMB-15

  Through treatment until EOT visit, expected average 6 months

• Maximum serum concentration (Cmax) of EMB-15

  Through treatment until EOT visit, expected average 6 months

• Trough concentration (Ctrough) of EMB-15

  Through treatment until EOT visit, expected average 6 months

• Average concentration over a dosing interval (Css, avg)of EMB-15

  Through treatment until EOT visit, expected average 6 months

• Terminal half-life (T1/2) of EMB-15

  Through treatment until EOT visit, expected average 6 months.

Study Arms (1)

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).

Biological: EMB-15

Interventions

EMB-15 BIOLOGICAL

EMB-15 is a recombinant humanized bi-specific antibody against ALPP/ALPG and CD3

EMB-15

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.
• \) Patients must provide archived tumor samples collected within 1 year. 7) Adequate hematological and organ function.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai EpimAb Biotherapeutics Co., Ltd.: lead

Study Sites (1)

Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

Central Study Contacts

Xi Yang

CONTACT

86-21-61951000; xyang@epimab.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: May 26, 2026
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): October 30, 2029
• Last Updated: June 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)