Informations générales (source: ClinicalTrials.gov)
First-in-Human Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of the BTK Degrader, ABBV-101, in Participants With B-cell Malignancies
Interventional
Phase 1
AbbVie (Voir sur ClinicalTrials)
juin 2023
mars 2031
06 août 2025
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: third line or later of treatment (3L) +
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
will include a dose escalation phase to determine the maximum administered dose
(MAD)/Maximum tolerated dose (MTD) of ABBV-101 and a dose expansion phase to determine
the change in disease activity in participants with CLL or non-GCB DLBCL. Approximately
244 adult participants with multiple NHL subtypes will be enrolled in the study in sites
world wide.
In the Dose Escalation phase of the study participants will receive escalating oral doses
of ABBV-101, until the MAD/MTD is determined, as part of the approximately 88 month study
duration. In the dose expansion phase of the study participants receive oral ABBV-101, 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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 256248 - 44000 - Nantes - Pays-de-la-Loire - France | Contact (sur clinicalTrials) | ||||
| CHRU Lille - Hopital Claude Huriez /ID# 253665 - 59037 - Lille - Nord - France | Contact (sur clinicalTrials) | ||||
| CHU Montpellier - Hopital Saint Eloi /ID# 253666 - 34295 - Montpellier Cedex 5 - Herault - France | Contact (sur clinicalTrials) | ||||
| Hôpital Saint-Louis /ID# 253663 - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonie /ID# 253664 - 33000 - Bordeaux - Gironde - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- For Dose Escalation (Part 1) only: Participants with documented diagnosis for one of
the following 3L+ B-cell malignancies, from one of the following WHO-defined
histologies (Swerdlow et al 2016):
- Chronic lymphocytic leukemia (CLL)
- Small lymphocytic lymphoma (SLL)
- 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)
- For Dose Expansion (Part 2) only: Participants with documented diagnosis of CLL who
are 3L+ including those with Bruton's tyrosine kinase (BTK) mutations or CAR-T/HCT
R/R or ineligible non-GCB DLBCL who are 3L+ with histology based on criteria
established by the World Health Organization (WHO).
- 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.
- Participants with prior central nervous system (CNS) disease that have been
effectively treated may be eligible.
- For Dose Escalation (Part 1) only: Participants with documented diagnosis for one of
the following 3L+ B-cell malignancies, from one of the following WHO-defined
histologies (Swerdlow et al 2016):
- Chronic lymphocytic leukemia (CLL)
- Small lymphocytic lymphoma (SLL)
- 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)
- For Dose Expansion (Part 2) only: Participants with documented diagnosis of CLL who
are 3L+ including those with Bruton's tyrosine kinase (BTK) mutations or CAR-T/HCT
R/R or ineligible non-GCB DLBCL who are 3L+ with histology based on criteria
established by the World Health Organization (WHO).
- 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.
- Participants with prior central nervous system (CNS) disease that have been
effectively treated may be eligible.
- Previously treated with a Bruton's tyrosine kinase (BTK) degrader.
- Known active CNS disease, or primary CNS lymphoma.
- Uncontrolled active systemic infection, or active cytomegalovirus infection, known
history of human immunodeficiency virus (HIV), active hepatitis B or C infection or
less than 12 weeks since achieving undetectable viral load in cases of prior active
hepatitis C.