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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 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

50

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510655
        • Rekruttering
        • Sixth Affiliated Hospital of Sun Yat-sen University
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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).
Biologisk: EMB-15
EMB-15 is a recombinant humanized bi-specific antibody against ALPP/ALPG and CD3

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Forekomst av alvorlige bivirkninger (SAE)
Tidsramme: Screening frem til oppfølging (30 dager etter siste dose)
Forekomst av SAE.
Screening frem til oppfølging (30 dager etter siste dose)
Doseintensitet
Tidsramme: Screening frem til oppfølging (30 dager etter siste dose)
Faktisk mengde legemiddel tatt av pasienter delt på planlagt mengde.
Screening frem til oppfølging (30 dager etter siste dose)
incidence and severity of adverse events as assessed by CTCAE v6.0 and ASTCT.
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Area under the serum concentration-time curve (AUC) of EMB-15
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Shanghai EpimAb Biotherapeutics Co., Ltd.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

26. mai 2026

Primær fullføring (Antatt)

31. mai 2029

Studiet fullført (Antatt)

30. oktober 2029

Datoer for studieregistrering

Først innsendt

19. mai 2026

Først innsendt som oppfylte QC-kriteriene

19. mai 2026

Først lagt ut (Faktiske)

26. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. juni 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • EMB15X101

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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