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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Primary Purpose

Status

Recruiting

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

ABBV-101

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

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

NCT ID

NCT05753501

First Posted

February 22, 2023

Last Updated

June 29, 2023

Sponsor

AbbVie

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

Hematologic Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial