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

11 juni 2026 bijgewerkt door: Shanghai EpimAb Biotherapeutics Co., Ltd.

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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).

Studietype

Ingrijpend

Inschrijving (Geschat)

50

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • Werving
        • Sixth Affiliated Hospital of Sun Yat-sen University
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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).
Biologisch: EMB-15
EMB-15 is a recombinant humanized bi-specific antibody against ALPP/ALPG and CD3

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidentie van ernstige bijwerkingen (SAE)
Tijdsspanne: Screening tot follow-up (30 dagen na de laatste dosis)
Incidentie van SAE.
Screening tot follow-up (30 dagen na de laatste dosis)
Dosis intensiteit
Tijdsspanne: Screening tot follow-up (30 dagen na de laatste dosis)
Werkelijke hoeveelheid geneesmiddel ingenomen door patiënten gedeeld door de geplande hoeveelheid.
Screening tot follow-up (30 dagen na de laatste dosis)
incidence and severity of adverse events as assessed by CTCAE v6.0 and ASTCT.
Tijdsspanne: Screening up to follow-up (30 days after the last dose)
Incidence and severity of AE.
Screening up to follow-up (30 days after the last dose)
Incidence of dose interruptions
Tijdsspanne: 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.
Screening up to follow-up (30 days after the last dose)
The incidence of DLTs during the DLT evaluation period.
Tijdsspanne: 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.
First infusion to the end of Cycle 1 (each cycle is 28 days)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Area under the serum concentration-time curve (AUC) of EMB-15
Tijdsspanne: Through treatment until EOT visit, expected average 6 months
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
Tijdsspanne: Through treatment until EOT visit, expected average 6 months
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
Tijdsspanne: Through treatment until EOT visit, expected average 6 months
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
Tijdsspanne: Through treatment until EOT visit, expected average 6 months
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
Tijdsspanne: Through treatment until EOT visit, expected average 6 months.
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
Tijdsspanne: Through treatment until EOT visit, expected average 6 months.
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
Tijdsspanne: Through treatment until EOT visit, expected average 6 months
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
Tijdsspanne: 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
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
Tijdsspanne: 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
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
Tijdsspanne: Up to End of Treatment Follow Up Period (30 days after the last dose)
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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Shanghai EpimAb Biotherapeutics Co., Ltd.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

26 mei 2026

Primaire voltooiing (Geschat)

31 mei 2029

Studie voltooiing (Geschat)

30 oktober 2029

Studieregistratiedata

Eerst ingediend

19 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

19 mei 2026

Eerst geplaatst (Werkelijk)

26 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

11 juni 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • EMB15X101

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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