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Studie för att utvärdera negativa händelser, förändring i sjukdomsaktivitet och hur oral ABBV-101 rör sig genom kroppen hos vuxna deltagare med B-cellsmalignitet

2 november 2026 uppdaterad av: AbbVie

Första i människa-studie för att utvärdera säkerhet, farmakokinetik och preliminär effekt av BTK Degrader, ABBV-101, hos deltagare med B-cellsmaligniteter

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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

135

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Frankrike
      • Paris, Frankrike, 75010
        • Hopital Saint-Louis /ID# 253663
    • Gironde
      • Bordeaux, Gironde, Frankrike, 33000
        • Institut Bergonie /ID# 253664
    • Herault
      • Montpellier, Herault, Frankrike, 34295
        • CHU Montpellier - Hopital Saint Eloi /ID# 253666
    • Nord
      • Lille, Nord, Frankrike, 59037
        • CHRU Lille - Hopital Claude Huriez /ID# 253665
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, Frankrike, 44000
        • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 256248
    • Val-de-Marne
      • Villejuif, Val-de-Marne, Frankrike, 94805
        • Institut Gustave Roussy /ID# 253662
  • Förenta staterna
    • Arizona
      • Tucson, Arizona, Förenta staterna, 85711
        • Arizona Oncology - Tucson - Wilmot Road /ID# 252351
    • California
      • Orange, California, Förenta staterna, 92868-3201
        • UC Irvine Medical Center /ID# 263020
      • Palo Alto, California, Förenta staterna, 94304
        • Stanford University - Palo Alto /ID# 249683
    • Colorado
      • Aurora, Colorado, Förenta staterna, 80012
        • Rocky Mountain Cancer Centers - Aurora /ID# 252237
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60611
        • Northwestern Medicine - Northwestern Memorial Hospital /ID# 249347
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02215-5400
        • Beth Israel Deaconess Medical Center /ID# 249302
    • New Jersey
      • New Brunswick, New Jersey, Förenta staterna, 08901
        • Rutgers Cancer Institute of New Jersey /ID# 249323
    • New York
      • Albany, New York, Förenta staterna, 12206-5013
        • New York Oncology Hematology - Albany Cancer Center /ID# 252240
      • Lake Success, New York, Förenta staterna, 11042
        • Northwell Health - Monter Cancer Center /ID# 250422
      • Rochester, New York, Förenta staterna, 14642-0001
        • University of Rochester Medical Center /ID# 249324
    • Ohio
      • Cincinnati, Ohio, Förenta staterna, 45267-2827
        • University of Cincinnati /ID# 249299
    • Oregon
      • Eugene, Oregon, Förenta staterna, 97401-6036
        • Oncology Assoc. of Oregon PC - WVCI and Research Ctr - Springfield /ID# 249309
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19104
        • University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 250341
    • Texas
      • Houston, Texas, Förenta staterna, 77030
        • MD Anderson Cancer Center /ID# 249293
  • 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
  • Kanada
    • Ontario
      • Toronto, Ontario, Kanada, M5G 2M9
        • University Health Network_Princess Margaret Cancer Centre /ID# 253483
    • Quebec
      • Montreal, Quebec, Kanada, H2X 3E4
        • Centre Hospitalier De L'Universite De Montreal - Hopital Saint-Luc /ID# 253428
  • 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
  • Storbritannien
    • Cambridgeshire
      • Cambridge, Cambridgeshire, Storbritannien, CB2 2QQ
        • Addenbrookes Hospital /ID# 256242
    • England
      • Leicester, England, Storbritannien, LE1 5WW
        • Leicester Royal Infirmary /ID# 255171
    • Greater London
      • London, Greater London, Storbritannien, SE5 9RS
        • Kings College Hospital NHS Foundation Trust /ID# 253670
      • London, Greater London, Storbritannien, NW1 2BU
        • UCLH NHS FT - University College Hospital /ID# 260202
  • 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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: ABBV-101

Oral:Tablet

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants with Adverse Events (AE)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Maximum Observed Serum Concentration (Cmax) of ABBV-101
Tidsram: Up to Approximately 88 Months

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AbbVie

Utredare

  • Studierektor: ABBVIE INC., AbbVie

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

9 juni 2023

Primärt slutförande (Beräknad)

1 mars 2031

Avslutad studie (Beräknad)

1 mars 2031

Studieregistreringsdatum

Först inskickad

22 februari 2023

Först inskickad som uppfyllde QC-kriterierna

22 februari 2023

Första postat (Faktisk)

3 mars 2023

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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