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A Study of MRG004A in Patients With Tissue Factor Positive Advanced or Metastatic Solid Tumors

12. maj 2026 opdateret af: Lepu Biopharma Co., Ltd.

An Open-Label, Multi-center, Phase I/II Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Anti-Tumor Activity and Pharmacokinetics of MRG004A in Patients With Tissue Factor Positive Advanced or Metastatic Solid Tumors

The objective of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of MRG004A in patients with Tissue Factor positive advanced or metastatic solid tumors.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study consists of two parts. Part A is a dose escalation study to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of MRG004A. Part B is a disease specific multi-cohort dose expansion study to further assess the efficacy and safety of MRG004A at confirmed RP2D.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

39

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Orange, California, Forenede Stater, 92868-3201
        • Chao Family Comprehensive Cancer Center
    • New York
      • New York, New York, Forenede Stater, 10065
        • Memorial Sloan Kettering 60th Street Outpatient Center
    • Ohio
      • Canton, Ohio, Forenede Stater, 44718
        • Gabrail Cancer Center Research
      • Cincinnati, Ohio, Forenede Stater, 45219
        • The Christ Hospital Cancer Center
    • Pennsylvania
      • Gettysburg, Pennsylvania, Forenede Stater, 17325
        • Gettysburg Cancer Center
    • Virginia
      • Fairfax, Virginia, Forenede Stater, 22031
        • Virginia Cancer Specialists
  • Kina
    • Hunan
      • Changsha, Hunan, Kina, 410013
        • Hunan Cancer Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 201321
        • Fudan University Shanghai Cancer Center
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310003
        • The First Affiliated Hospital, College of Medicine, Zhejiang University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Understands and provides written informed consent and willing to follow the requirements specified in protocol.
  2. Age ≥18 years.
  3. Life expectancy ≥6 months.
  4. For Part B patients, documented Tissue Factor (TF) presence in tumor biopsy specimens obtained from archival or re-biopsy specimens by immunohistochemistry (IHC) protein expression.
  5. Must have histologically or cytologically confirmed unresectable or metastatic cancer with documented disease progression during prior therapy, or relapse or progression following approved standard therapy for their tumor types- Part A and Part B.
  6. Part B: Patients who have documented progression during or relapse following standard therapy, no further treatment options that are known to improve survival, and participation in a clinical trial is a reasonable therapeutic option.
  7. Patients must have measurable disease per RECIST v1.1.
  8. ECOG performance status of 0 or 1.
  9. Acceptable bone marrow, hepatic, cardiac, renal, and coagulation function.
  10. A negative serum pregnancy test if female and aged between 18-55 years old.
  11. Patients, both females and males, of reproductive potential must agree to use adequate contraception during and for 180 days after the last infusion of MRG004A.

Exclusion Criteria:

  1. Archival or biopsy tumor shows TF IHC membrane or cytosolic score of zero, no TF-positive expression or no TF-positive staining in Part B patients.
  2. Toxicities (except alopecia & fatigue) due to prior antitumor therapy are greater than CTCAE v5.0 Grade 1.
  3. Toxicities due to prior radiotherapy that have not resolved to Grade ≤ 1 CTCAE v5.0 at least 21 days prior to the first treatment.
  4. Untreated, unstable or uncontrolled central nervous system (CNS) metastases.
  5. Any other type of anti-cancer therapy within 21 days of the first dose of study treatment. Use of any other type of anti-cancer treatment is prohibited throughout the study.
  6. Patients with increased bleeding risk.
  7. Presence of severe cardiac dysfunction.
  8. Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug.
  9. Concurrent malignancy within 5 years prior to entry.
  10. Uncontrolled or poorly controlled hypertension.
  11. History of ventricular tachycardia, or torsade des pointes.
  12. History of moderate to severe dyspnea at rest.
  13. Major surgery within 4 weeks of the first dose of study treatment and not fully recovered. Minor surgery within 2 weeks prior to study treatment.
  14. Known allergic reactions to any component or excipient of MRG004A or known allergic reactions to other prior anti-TF (including investigational) or other monoclonal antibody ≥ Grade 3.
  15. Patients who have any known liver disease, including chronic hepatitis B, hepatitis C, autoimmune hepatic disorders, primary biliary cirrhosis or sclerosing cholangitis; Patients who have concurrent, serious, uncontrolled infections or known infection with HIV, or have a diagnosed acquired immunodeficiency syndrome (AIDS); or an uncontrolled autoimmune disease, or have undergone organ transplant.
  16. Active uncontrolled bacterial, viral, fungal, rickettsial, or parasitic infection.
  17. Use of systemic corticosteroids within 4 weeks prior to the first dose of treatment.
  18. Use of strong CYP3A4 inhibitors or inducers with MRG004A.
  19. Other excluded medications or treatment: therapeutic anti-coagulative, or long-term anti-platelet treatment; multivitamins, calcium, vitamin D, and prophylactic anti-RANKL (denosumab) and zoledronic acid therapies for bone metastases are allowed.
  20. Any patient with a positive pregnancy or is breast-feeding.
  21. Any severe and/or uncontrolled systemic disease that at the discretion of investigator and sponsor makes it undesirable for the patient to participate in this study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: MRG004A
All patients in Part A (dose escalation) and Part B (dose expansion) will be administrated MRG004A on Day 1 of every 3 weeks (21-day cycle).
Medicin: MRG004A
Administrated intravenously

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum Tolerated Dose (MTD)
Tidsramme: DLT will be evaluated during the first treatment cycle (Day 1-21)
The highest dose confirmed wherein less than 2 out of 6, or < 33% of evaluable patients in a treatment cohort experiences dose-limiting toxicity (DLT).
DLT will be evaluated during the first treatment cycle (Day 1-21)
Recommended Phase II Dose (RP2D)
Tidsramme: Baseline to study completion (up to 24 months)
The dose level of MRG004A recommended for further clinical studies based on assessment of the safety, efficacy and PK data from Part A of this study.
Baseline to study completion (up to 24 months)
Objective Response Rate (ORR)
Tidsramme: Baseline to study completion (up to 24 months)
The proportion of patients who achieve complete response (CR) or partial response (PR) as assessed by the Independent Central Review (ICR).
Baseline to study completion (up to 24 months)
Adverse Events (AEs)
Tidsramme: From signing informed consent until 45 days after the last dose of MRG004A
Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.
From signing informed consent until 45 days after the last dose of MRG004A

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Responsens varighed (DOR)
Tidsramme: Baseline til studieafslutning (op til 24 måneder)
Tidsintervallet mellem datoen for den tidligste kvalificerende respons og datoen for sygdomsprogression eller død for enhver årsag, alt efter hvad der sker tidligere.
Baseline til studieafslutning (op til 24 måneder)
Disease Control Rate (DCR)
Tidsramme: Baseline to study completion (up to 24 months)
The proportion of patients who achieve CR, PR, or stable disease (SD) ≥ 6 weeks based on RECIST v1.1.
Baseline to study completion (up to 24 months)
Progression Free Survival (PFS)
Tidsramme: Baseline to study completion (up to 24 months)
The time from the date of first study dose to disease progression or death whichever occurs first.
Baseline to study completion (up to 24 months)
Overall Survive (OS)
Tidsramme: Baseline to study completion (up to 24 months)
The time from start of study treatment to date of death as a result of any cause.
Baseline to study completion (up to 24 months)
Pharmacokinetics (PK) Parameter of MRG004A: Cmax
Tidsramme: Baseline to 30 days after the last dose of study treatment
Maximum observed plasma concentration.
Baseline to 30 days after the last dose of study treatment
Pharmacokinetics (PK) Parameter of MRG004A: Tmax
Tidsramme: Baseline to 30 days after the last dose of study treatment
Time to reach the maximum plasma concentration.
Baseline to 30 days after the last dose of study treatment
Pharmacokinetics (PK) Parameter of MRG004A: AUClast
Tidsramme: Baseline to 30 days after the last dose of study treatment
Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration.
Baseline to 30 days after the last dose of study treatment
Forekomst af antistof antistof (ADA)
Tidsramme: Baseline til 30 dage efter den sidste dosis af undersøgelsesbehandlingen
Andelen af ​​patienter med positiv ADA-immunogenicitet resultater.
Baseline til 30 dage efter den sidste dosis af undersøgelsesbehandlingen

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Lepu Biopharma Co., Ltd.

Efterforskere

  • Ledende efterforsker: Nashat Y Gabrail, MD, Gabrail Cancer Center Research

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. juli 2021

Primær færdiggørelse (Faktiske)

20. marts 2024

Studieafslutning (Faktiske)

26. juli 2024

Datoer for studieregistrering

Først indsendt

8. april 2021

Først indsendt, der opfyldte QC-kriterier

11. april 2021

Først opslået (Faktiske)

13. april 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MRG004A-001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Avancerede eller metastatiske solide tumorer

Kliniske forsøg med MRG004A

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Sponsorer og samarbejdspartnere

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Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner