A First-in-human Phase I Study to Evaluate EMB-15 in Patients With Locally Advanced or Metastatic Solid Tumors.
11. Juni 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Intervention / Behandlung
Detaillierte Beschreibung
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).
Studientyp
Interventionell
Einschreibung (Geschätzt)
50
Phase
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Xi Yang
- Telefonnummer: 86-21-61951000
- E-Mail: xyang@epimab.com
Studienorte
-
-
Guangdong
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Guangzhou, Guangdong, China, 510655
- Rekrutierung
- Sixth Affiliated Hospital of Sun Yat-sen University
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Kontakt:
- Mingfei Zhang
- Telefonnummer: 86-21-61951000
- E-Mail: mfzhang@epimab.com
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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:
- 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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Sequenzielle Zuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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).
|
EMB-15 is a recombinant humanized bi-specific antibody against ALPP/ALPG and CD3
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Auftreten schwerwiegender unerwünschter Ereignisse (SAE)
Zeitfenster: Screening bis zur Nachuntersuchung (30 Tage nach der letzten Dosis)
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Auftreten von SAE.
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Screening bis zur Nachuntersuchung (30 Tage nach der letzten Dosis)
|
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Dosisintensität
Zeitfenster: Screening bis zur Nachuntersuchung (30 Tage nach der letzten Dosis)
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Tatsächliche Medikamentenmenge, die von Patienten eingenommen wird, dividiert durch die geplante Menge.
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Screening bis zur Nachuntersuchung (30 Tage nach der letzten Dosis)
|
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incidence and severity of adverse events as assessed by CTCAE v6.0 and ASTCT.
Zeitfenster: Screening up to follow-up (30 days after the last dose)
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Incidence and severity of AE.
|
Screening up to follow-up (30 days after the last dose)
|
|
Incidence of dose interruptions
Zeitfenster: 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.
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Screening up to follow-up (30 days after the last dose)
|
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The incidence of DLTs during the DLT evaluation period.
Zeitfenster: First infusion to the end of Cycle 1 (each cycle is 28 days)
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The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and are specifically defined in study protocol.
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First infusion to the end of Cycle 1 (each cycle is 28 days)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Area under the serum concentration-time curve (AUC) of EMB-15
Zeitfenster: 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
|
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Maximum serum concentration (Cmax) of EMB-15
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Through treatment until EOT visit, expected average 6 months.
|
Blood samples for serum PK analysis will be obtained (T1/2)
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Through treatment until EOT visit, expected average 6 months.
|
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Systemic clearance (CL) of EMB-15
Zeitfenster: Through treatment until EOT visit, expected average 6 months.
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Blood samples for serum PK analysis will be obtained (CL).
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Through treatment until EOT visit, expected average 6 months.
|
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Steady state volume of distribution (Vss) of EMB-15
Zeitfenster: Through treatment until EOT visit, expected average 6 months
|
Blood samples for serum PK analysis will be obtained (Vss).
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Through treatment until EOT visit, expected average 6 months
|
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Progression free survival (PFS) of EMB-15 as assessed by RECIST 1.1
Zeitfenster: 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
|
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Duration of response of EMB-15 as assessed by RECIST 1.1
Zeitfenster: 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
|
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Incidence and titer of anti-drug antibodies stimulated by EMB-15
Zeitfenster: Up to End of Treatment Follow Up Period (30 days after the last dose)
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Antibodies to EMB-15 will be assessed to evaluate potential immunogenicity.
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Up to End of Treatment Follow Up Period (30 days after the last dose)
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
26. Mai 2026
Primärer Abschluss (Geschätzt)
31. Mai 2029
Studienabschluss (Geschätzt)
30. Oktober 2029
Studienanmeldedaten
Zuerst eingereicht
19. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
19. Mai 2026
Zuerst gepostet (Tatsächlich)
26. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
15. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
11. Juni 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Plan für individuelle Teilnehmerdaten (IPD)
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NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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