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Undersøgelse for at evaluere uønskede hændelser, ændring i sygdomsaktivitet og hvordan oral ABBV-101 bevæger sig gennem kroppen hos voksne deltagere med B-celle malignitet

2. november 2026 opdateret af: AbbVie

Første-i-menneske-undersøgelse til evaluering af sikkerheden, farmakokinetikken og den foreløbige effektivitet af BTK Degrader, ABBV-101, hos deltagere med B-celle malignitet

Non-Hodgkin's lymphoma (NHL) is a cancer that arises from the transformation of normal B and T lymphocytes (white blood cells). The purpose of this study is to assess the safety, pharmacokinetics, and preliminary efficacy of ABBV-101 in adult participants in relapsed or refractory (R/R) non-Hodgkin's lymphomas: chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), diffuse large b-cell lymphoma (DLBCL), non-germinal center B cell (GCB) DLBCL, mantle cell lymphoma (MCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), Waldenström macroglobulinemia (WM), or transformed indolent NHL. Adverse events will be assessed.

ABBV-101 is an investigational drug being developed for the treatment of NHL. This study is a dose escalation phase to determine the maximum administered dose (MAD)/Maximum tolerated dose (MTD) of ABBV-101. Approximately 200 adult participants with multiple NHL subtypes will be enrolled in the study in sites world wide.

Participants will receive escalating oral doses of ABBV-101, until the MAD/MTD is determined, as part of the approximately 88 month study duration.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

135

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network_Princess Margaret Cancer Centre /ID# 253483
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Centre Hospitalier De L'Universite De Montreal - Hopital Saint-Luc /ID# 253428
  • Det Forenede Kongerige
    • Cambridgeshire
      • Cambridge, Cambridgeshire, Det Forenede Kongerige, CB2 2QQ
        • Addenbrookes Hospital /ID# 256242
    • England
      • Leicester, England, Det Forenede Kongerige, LE1 5WW
        • Leicester Royal Infirmary /ID# 255171
    • Greater London
      • London, Greater London, Det Forenede Kongerige, SE5 9RS
        • Kings College Hospital NHS Foundation Trust /ID# 253670
      • London, Greater London, Det Forenede Kongerige, NW1 2BU
        • UCLH NHS FT - University College Hospital /ID# 260202
  • Forenede Stater
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85711
        • Arizona Oncology - Tucson - Wilmot Road /ID# 252351
    • California
      • Orange, California, Forenede Stater, 92868-3201
        • UC Irvine Medical Center /ID# 263020
      • Palo Alto, California, Forenede Stater, 94304
        • Stanford University - Palo Alto /ID# 249683
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80012
        • Rocky Mountain Cancer Centers - Aurora /ID# 252237
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern Medicine - Northwestern Memorial Hospital /ID# 249347
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215-5400
        • Beth Israel Deaconess Medical Center /ID# 249302
    • New Jersey
      • New Brunswick, New Jersey, Forenede Stater, 08901
        • Rutgers Cancer Institute of New Jersey /ID# 249323
    • New York
      • Albany, New York, Forenede Stater, 12206-5013
        • New York Oncology Hematology - Albany Cancer Center /ID# 252240
      • Lake Success, New York, Forenede Stater, 11042
        • Northwell Health - Monter Cancer Center /ID# 250422
      • Rochester, New York, Forenede Stater, 14642-0001
        • University of Rochester Medical Center /ID# 249324
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45267-2827
        • University of Cincinnati /ID# 249299
    • Oregon
      • Eugene, Oregon, Forenede Stater, 97401-6036
        • Oncology Assoc. of Oregon PC - WVCI and Research Ctr - Springfield /ID# 249309
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 250341
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • MD Anderson Cancer Center /ID# 249293
  • Frankrig
      • Paris, Frankrig, 75010
        • Hopital Saint-Louis /ID# 253663
    • Gironde
      • Bordeaux, Gironde, Frankrig, 33000
        • Institut Bergonie /ID# 253664
    • Herault
      • Montpellier, Herault, Frankrig, 34295
        • CHU Montpellier - Hopital Saint Eloi /ID# 253666
    • Nord
      • Lille, Nord, Frankrig, 59037
        • CHRU Lille - Hopital Claude Huriez /ID# 253665
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, Frankrig, 44000
        • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 256248
    • Val-de-Marne
      • Villejuif, Val-de-Marne, Frankrig, 94805
        • Institut Gustave Roussy /ID# 253662
  • Israel
    • Central District
      • Tsrifin, Central District, Israel, 70300
        • Yitzhak Shamir Medical Center /ID# 254566
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 91120
        • Hadassah Medical Center-Hebrew University /ID# 251123
    • Tel Aviv
      • Ramat Gan, Tel Aviv, Israel, 5265601
        • The Chaim Sheba Medical Center /ID# 251122
      • Tel Aviv, Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center /ID# 259608
  • Italien
      • Bergamo, Italien, 24127
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII /ID# 260317
      • Bologna, Italien, 40138
        • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 255172
    • Milano
      • Milan, Milano, Italien, 20132
        • IRCCS Ospedale San Raffaele /ID# 253531
      • Milan, Milano, Italien, 20162
        • ASST Grande Ospedale Metropolitano Niguarda /ID# 253532
    • Piedmont
      • Turin, Piedmont, Italien, 10126
        • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 253530
  • Japan
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East /ID# 250684
    • Kyoto
      • Kyoto, Kyoto, Japan, 606-8507
        • Kyoto University Hospital /ID# 261837
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital /ID# 250680
      • Koto-ku, Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 260375
  • Spanien
      • Barcelona, Spanien, 08035
        • Hospital Universitario Vall de Hebron /ID# 260447
      • Madrid, Spanien, 28034
        • Hospital Universitario Ramon y Cajal /ID# 260450
      • Madrid, Spanien, 28040
        • Hospital Universitario Fundacion Jimenez Diaz /ID# 253654
      • Madrid, Spanien, 28050
        • Hospital Universitario HM Sanchinarro /ID# 253655
      • Salamanca, Spanien, 37711
        • Hospital Universitario de Salamanca /ID# 253656
    • Madrid
      • Majadahonda, Madrid, Spanien, 28222
        • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 260196
  • Tyskland
      • Berlin, Tyskland, 12203
        • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 257431
      • Hamburg, Tyskland, 20246
        • Universitaetsklinikum Hamburg-Eppendorf /ID# 264566
    • Baden-Wurttemberg
      • Ulm, Baden-Wurttemberg, Tyskland, 89081
        • Universitaetsklinikum Ulm /ID# 253742
    • Bavaria
      • Würzburg, Bavaria, Tyskland, 97080
        • Universitaetsklinikum Wuerzburg /ID# 254636
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Tyskland, 18057
        • Universitaetsmedizin Rostock /ID# 259657
    • Saarland
      • Homburg, Saarland, Tyskland, 66424
        • Universitaetsklinikum des Saarlandes /ID# 257435

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

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • For Dose Escalation only (including backfill): Participants have received at least two prior systemic therapies, have no available therapies known to provide clinical benefit (e.g., standard chemotherapy or HCT), have measurable disease requiring treatment, and have a documented diagnosis for one of the following third line or later B-cell malignancies, from one of the following world health organization (WHO)-defined histologies (Swerdlow et al 2016):

    • Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)

      1. For Dose Escalation backfill only - Bruton's tyrosine kinase inhibitor (BTKi)/Bruton's tyrosine kinase degrader (BTKd)-naïve CLL/SLL. Participants with a documented diagnosis of CLL/SLL who have received at least one prior systemic therapy that cannot be a BTK inhibitor or degrader, and, with the exception of BTK pathway agents, have no available therapies known to provide clinical benefit (e.g., standard chemotherapy or HCT), and have measurable disease requiring treatment.
      2. For Dose Escalation backfill only - BTKi/BCL-2i combination regimen-exposed 2L CLL/SLL. Participants with a documented diagnosis of CLL/SLL who have received one prior systemic therapy with a BTKi and BCL-2i combination regimen, have no available therapies known to provide clinical benefit (e.g., standard chemotherapy or HCT), and have measurable disease requiring treatment.

    • Chimeric antigen receptor T-cells (CAR-T)/hematopoietic cell transplant (HCT) relapsed/refractory (R/R) or ineligible diffuse large b-cell lymphoma (DLBCL) from the following histologies: DLBCL not otherwise specified (NOS) (germinal center B cell [GCB] and non-GCB DLBCL), T-cell/histiocyte-rich large B-cell lymphoma, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, anaplastic lymphoma kinase positive (ALK+) large B-cell lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma NOS.

    • Mantle cell lymphoma (MCL)

    • Follicular lymphoma [FL] (grades 1-3b)

    • Marginal zone lymphoma [MZL] (splenic, extranodal, and nodal)

    • Waldenström macroglobulinemia (WM)

    • Transformed indolent non-Hodgkin's lymphoma (iNHL)

  • Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2. For EU only: Participant has an ECOG PS of 0 or 1.

  • Participant has a life expectancy >= 12 weeks.

  • Prior Bruton's tyrosine kinase inhibitor (BTKi) is allowed.

  • Adequate hematologic, renal, and hepatic function per the protocol.

Exclusion Criteria:

  • Previously treated with a Bruton's tyrosine kinase (BTK) degrader, except ABBV-101.
  • Known active central nervous system (CNS) disease, or primary CNS lymphoma. Participants with prior CNS disease that have been effectively treated may be eligible.
  • Uncontrolled active systemic infection requiring systemic treatment that is ongoing or was completed <= 14 days before the first dose of study drug, or active cytomegalovirus infection.

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: Dose Escalation: ABBV-101

Participants with relapsed or refractory (R/R) Non-Hodgkin's lymphoma (NHL) will receive escalating doses of ABBV-101, until the maximum administered dose (MAD)/Maximum tolerated dose (MTD) is determined, as part of the approximately 88 month study duration.
Medicin: ABBV-101

Oral:Tablet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants with Adverse Events (AE)
Tidsramme: Up to Approximately 88 Months

AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Up to Approximately 88 Months
Change in Laboratory Parameters
Tidsramme: Up to Approximately 88 Months

Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported.
Up to Approximately 88 Months
Change in Vital Signs
Tidsramme: Up to Approximately 88 Months

Number of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported.
Up to Approximately 88 Months
Change in Electrocardiogram (ECG)
Tidsramme: Up to Approximately 88 Months

12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.
Up to Approximately 88 Months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum Observed Serum Concentration (Cmax) of ABBV-101
Tidsramme: Up to Approximately 88 Months

Maximum observed serum concentration of ABBV-101.
Up to Approximately 88 Months
Time to Cmax (Tmax) of ABBV-101
Tidsramme: Up to Approximately 88 Months

Time to Cmax of ABBV-101.
Up to Approximately 88 Months
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-101
Tidsramme: Up to Approximately 88 Months

Area under the serum concentration versus time curve (AUC) of ABBV-101.
Up to Approximately 88 Months
Number of Participants with Response of Partial Response (PR) or Better Response (Overall Response) per Disease-Specific Criteria
Tidsramme: Up to Approximately 88 Months

Number of participants with response of PR or better response (overall response) per disease-specific criteria.
Up to Approximately 88 Months
Duration of Response (DOR)
Tidsramme: Up to Approximately 88 Months

DOR is defined for participants achieving PR or better as the time from the initial response per Investigator review to disease progression or death of any cause, whichever occurs earlier.
Up to Approximately 88 Months

Samarbejdspartnere og efterforskere

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

Sponsor

AbbVie

Efterforskere

  • Studieleder: ABBVIE INC., AbbVie

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)

9. juni 2023

Primær færdiggørelse (Anslået)

1. marts 2031

Studieafslutning (Anslået)

1. marts 2031

Datoer for studieregistrering

Først indsendt

22. februar 2023

Først indsendt, der opfyldte QC-kriterier

22. februar 2023

Først opslået (Faktiske)

3. marts 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • M23-647
  • 2023 (U.S. NIH-bevilling/kontrakt)
  • 2023-503594-38-00 (Ctis)

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

produkt fremstillet i og eksporteret fra U.S.A.

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 .

Abonner