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Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies

Primary Purpose

Hematologic Cancer

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ABBV-101
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Cancer focused on measuring 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), Mantle cell lymphoma (MCL), Follicular lymphoma (FL), Marginal zone lymphoma (MZL), Waldenström macroglobulinemia (WM), Transformed Indolent non-Hodgkin's lymphoma (INHL), Hematologic Cancer, ABBV-101

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. 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. Exclusion Criteria: 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.

Sites / Locations

  • Arizona Oncology Associates, PC-HOPE/ID# 252351Recruiting
  • Rocky Mountain Cancer Centers /ID# 252237
  • Rocky Mountain Cancer Centers/ID# 252237Recruiting
  • New York Oncology Hematology - Albany Cancer Center /ID# 252240Recruiting
  • Northwell Health - Monter Cancer Center /ID# 250422
  • University of Rochester Cancer Center /ID# 249324
  • Oncology Assoc. of Oregon PC - WVCI and Research Ctr - Springfield/ID# 249309Recruiting
  • University of Pennsylvania /ID# 250341
  • MD Anderson Cancer Center /ID# 249293
  • The Chaim Sheba Medical Center /ID# 251122Recruiting
  • Hadassah Medical Center-Hebrew University /ID# 251123Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Dose Escalation ABBV-101

Dose Expansion ABBV-101 R/R Chronic Lymphocytic Lymphoma (CLL)

Dose Expansion ABBV-101 R/R non-GCB DLBCL

Arm Description

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 60 month study duration.

Participants with R/R CLL will receive ABBV-101 at the dose determined in the dose escalation arm, as part of the approximately 60 month study duration.

Participants with R/R non-germinal center B cell (GCB) diffuse large B-cell lymphoma (DLBCL) will receive ABBV-101 at the dose determined in the dose escalation arm, as part of the approximately 60 month study duration.

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events (AE)
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.
Change in Laboratory Parameters
Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported.
Change in Vital Signs
Number of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported.
Change in Electrocardiogram (ECG)
12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.

Secondary Outcome Measures

Maximum Observed Serum Concentration (Cmax) of ABBV-101
Maximum observed serum concentration of ABBV-101.
Time to Cmax (Tmax) of ABBV-101
Time to Cmax of ABBV-101.
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-101
Area under the serum concentration versus time curve (AUC) of ABBV-101.
Number of Participants with Response of Partial Response (PR) or Better per Disease-Specific Criteria
Number of participants with response of PR or better per disease-specific criteria.
Duration of Response (DOR)
DOR is defined for participants achieving a complete response (CR)/PR as the time from the initial response per investigator review to disease progression or death of any cause, whichever occurs earlier.

Full Information

First Posted
February 22, 2023
Last Updated
June 29, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT05753501
Brief Title
Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies
Official Title
First-in-Human Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of the BTK Degrader, ABBV-101, in Participants With B-cell Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2023 (Actual)
Primary Completion Date
June 7, 2027 (Anticipated)
Study Completion Date
June 7, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 188 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 60 month study duration. In the dose expansion phase of the study participants receive oral ABBV-101, as part of the approximately 60 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Cancer
Keywords
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), Mantle cell lymphoma (MCL), Follicular lymphoma (FL), Marginal zone lymphoma (MZL), Waldenström macroglobulinemia (WM), Transformed Indolent non-Hodgkin's lymphoma (INHL), Hematologic Cancer, ABBV-101

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation ABBV-101
Arm Type
Experimental
Arm Description
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 60 month study duration.
Arm Title
Dose Expansion ABBV-101 R/R Chronic Lymphocytic Lymphoma (CLL)
Arm Type
Experimental
Arm Description
Participants with R/R CLL will receive ABBV-101 at the dose determined in the dose escalation arm, as part of the approximately 60 month study duration.
Arm Title
Dose Expansion ABBV-101 R/R non-GCB DLBCL
Arm Type
Experimental
Arm Description
Participants with R/R non-germinal center B cell (GCB) diffuse large B-cell lymphoma (DLBCL) will receive ABBV-101 at the dose determined in the dose escalation arm, as part of the approximately 60 month study duration.
Intervention Type
Drug
Intervention Name(s)
ABBV-101
Intervention Description
Oral:Tablet
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events (AE)
Description
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.
Time Frame
Up to Approximately Two Years
Title
Change in Laboratory Parameters
Description
Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported.
Time Frame
Up to Approximately Two Years
Title
Change in Vital Signs
Description
Number of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported.
Time Frame
Up to Approximately Two Years
Title
Change in Electrocardiogram (ECG)
Description
12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.
Time Frame
Up to Approximately Two Years
Secondary Outcome Measure Information:
Title
Maximum Observed Serum Concentration (Cmax) of ABBV-101
Description
Maximum observed serum concentration of ABBV-101.
Time Frame
Up to Approximately One Year
Title
Time to Cmax (Tmax) of ABBV-101
Description
Time to Cmax of ABBV-101.
Time Frame
Up to Approximately One Year
Title
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-101
Description
Area under the serum concentration versus time curve (AUC) of ABBV-101.
Time Frame
Up to Approximately One Year
Title
Number of Participants with Response of Partial Response (PR) or Better per Disease-Specific Criteria
Description
Number of participants with response of PR or better per disease-specific criteria.
Time Frame
Up to Approximately Two Years
Title
Duration of Response (DOR)
Description
DOR is defined for participants achieving a complete response (CR)/PR as the time from the initial response per investigator review to disease progression or death of any cause, whichever occurs earlier.
Time Frame
Up to Approximately Two Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Oncology Associates, PC-HOPE/ID# 252351
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284-1812
Country
United States
Individual Site Status
Recruiting
Facility Name
Rocky Mountain Cancer Centers /ID# 252237
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Rocky Mountain Cancer Centers/ID# 252237
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Individual Site Status
Recruiting
Facility Name
New York Oncology Hematology - Albany Cancer Center /ID# 252240
City
Albany
State/Province
New York
ZIP/Postal Code
12206-5013
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwell Health - Monter Cancer Center /ID# 250422
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Rochester Cancer Center /ID# 249324
City
Rochester
State/Province
New York
ZIP/Postal Code
14642-0001
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Oncology Assoc. of Oregon PC - WVCI and Research Ctr - Springfield/ID# 249309
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401-6036
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pennsylvania /ID# 250341
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
MD Anderson Cancer Center /ID# 249293
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
The Chaim Sheba Medical Center /ID# 251122
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah Medical Center-Hebrew University /ID# 251123
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M23-647
Description
Related info

Learn more about this trial

Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies

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