AzTrials
AzTrials

B-cell LymphomaPhase 1NCT04804254

Study to Evaluate Adverse Events, Change in Disease Activity, Movement of Oral ABBV-623 and ABBV-992 Tablets in the Body of Adult Participants With B-cell Cancers

A Phase 1 study testing ABBV-623 and ABBV-992 in people with B-cell Lymphoma, run by AbbVie at 5 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

B-cell cancer is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The main objective of this study is to evaluate the safety and efficacy of ABBV-623 and ABBV-992 given alone and in combination in treating B-cell cancers. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-cell Lymphoma
What is being tested?
ABBV-623 and ABBV-992
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
5 sitesin 3 countries
Study dates
27 Apr 2021to 11 Jan 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have documented diagnosis for one of the following B-cell malignancies: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Mantle Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), Waldenström's macroglobulinemia (WM), diffuse large B-cell lymphoma (DLBCL), and follicular lymphoma (FL), with measurable disease requiring treatment.
  • Participants have relapsed or refractory to at least 2 prior systemic therapies.
  • Combination Dose Expansion Only: Participants with documented diagnosis of CLL/SLL with measurable disease requiring treatment per by International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • CLL/SLL, MCL, WM, MZL only: Prior Bruton's tyrosine kinase inhibitor (BTKi) exposure will be allowed if participant did not progress on active treatment and there is no evidence of resistance mutations.
  • Renal, liver and hematological function lab values as determined in the protocol.
  • For participants with prior BTK inhibitor exposure, no evidence of mutations which confer resistance to covalent BTK inhibitors.

Who cannot join

  • Participants with indolent forms of non-Hodgkin lymphoma (NHL) that require immediate cytoreduction.
  • Participants with prior B-cell lymphoma 2 (BCL2) inhibitor (BCL2i) exposure (except for participants in the ABBV-992 monotherapy cohort).

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

Israel2 sites

  • The Chaim Sheba Medical Center /ID# 226754

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 226755

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Turkey (Türkiye)2 sites

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 226087

    Ankara, 06200

  • Dokuz Eylul University Medical Faculty /ID# 226085

    Izmir, 35340

Other trials in Turkey (Türkiye)

Puerto Rico1 site

  • Hospital del Centro Comprensivo de Cancer de la UPR /ID# 225646

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: A Phase 1 First-in-Human, Multicenter, Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of ABBV-623 and ABBV-992 in Subjects With B-cell Malignancies

B-cell cancer is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The main objective of this study is to evaluate the safety and efficacy of ABBV-623 and ABBV-992 given alone and in combination in treating B-cell cancers. Adverse events, change in disease activity and how the drug moves through the body of adult participants with B-cell cancers will be evaluated.

ABBV-623 and ABBV-992 are investigational drugs being developed for the treatment of B-cell cancer. Study doctors assign participants to one of six groups, called treatment arms. Approximately 105 adult participants with a diagnosis of B-cell cancer will be enrolled in the study at approximately 50 sites worldwide.

Read more

Participants in the combination expansion treatment arms will receive oral tablets of ABBV-623 and/or ABBV-992 once daily for 24 months. All other arms are treated until progression.

Participants will attend regular visits during the study at a hospital or clinic. The effect of treatment will be evaluated by medical assessments and blood tests. Adverse events will be collected and assessed throughout the clinical trial.

Conditions
B-cell Lymphoma
Being tested
ABBV-623, ABBV-992
Keywords
ABBV-623, ABBV-992, B-cell lymphoma, Cancer, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Mantle Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), Waldenström's Macroglobulinemia (WM), Diffuse Large B-cell Lymphoma, Follicular Lymphoma
Medical subject headings
Lymphoma, B-Cell, Neoplasms, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone, Waldenstrom Macroglobulinemia, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-623Drug

    Oral Tablets

  • ABBV-992Drug

    Oral Tablets

Study groups in NCT04804254
Study groupRoleWhat they receive
Monotherapy in Dose Escalation: ABBV-623ExperimentalParticipants with Relapsed/Refractory (R/R) B-cell malignancies will receive escalating doses of ABBV-623.
Receives: Drug: ABBV-623
Monotherapy in Dose Escalation: ABBV-992ExperimentalParticipants with R/R B-cell malignancies will receive escalating doses of ABBV-992.
Receives: Drug: ABBV-992
Combination in Dose EscalationExperimentalParticipants with R/R B-cell malignancies will receive escalating doses of ABBV-623 and ABBV-992.
Receives: Drug: ABBV-623; Drug: ABBV-992
Monotherapy in Dose Expansion: ABBV-623ExperimentalParticipants with R/R B-cell malignancies will receive ABBV-623 at recommended Phase 2 dose (RP2D) determined in dose escalation phase.
Receives: Drug: ABBV-623
Monotherapy in Dose Expansion: ABBV-992ExperimentalParticipants with R/R B-cell malignancies will receive ABBV-992 at recommended Phase 2 dose (RP2D) determined in dose escalation phase.
Receives: Drug: ABBV-992
Combination in Dose ExpansionExperimentalParticipants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) will receive ABBV-623 and ABBV-992 at recommended Phase 2 dose (RP2D) determined in dose escalation phase.
Receives: Drug: ABBV-623; Drug: ABBV-992

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Adverse Events (AEs)

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

    Measured: Up to approximately 25 months.

  2. Dose Escalation: Maximum Observed Plasma Concentration (Cmax) of ABBV-623

    The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that ABBV-623 achieves in the blood after administration in a dosing interval.

    Measured: Up to approximately 96 weeks

  3. Dose Escalation: Area Under the Plasma Concentration- Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration of ABBV-623

    The area under the plasma concentration-time curve (AUC; measured in h*ng/mL/mg) is a method of measurement of the total exposure of ABBV-623 in blood plasma.

    Measured: Up to approximately 96 weeks

  4. Dose Escalation: Maximum Observed Plasma Concentration (Cmax) of ABBV-992

    The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that ABBV-992 achieves in the blood after administration in a dosing interval.

    Measured: Up to approximately 96 weeks.

  5. Dose Escalation: Area Under the Plasma Concentration- Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration of ABBV-992

    The area under the plasma concentration-time curve (AUC; measured in h*ng/mL/mg) is a method of measurement of the total exposure of ABBV-992 in blood plasma.

    Measured: Up to approximately 96 weeks

  6. Combination Dose Expansion: Overall Response Rate (ORR) (PR or Better by IWCLL Criteria) in Participants With R/R CLL/SLL

    ORR is the proportion of R/R CLL/SLL participants achieving a response of PR or better per IWCLL without the use of new anti-cancer therapy.

    Measured: Up to approximately 2 years

Secondary outcomes (13)

  1. Dose Escalation in Participants With R/R B-cell Malignancies: Percentage of Participants Achieving a Response of Partial Response (PR) or Better per Disease-Specific Response Criteria (e.g., IWCLL, Lugano, IWWM)

    Partial response (PR) as per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) , Lugano, International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria in protocol.

    Measured: Up to approximately 2 years

  2. Dose Escalation in Participants With R/R B-cell Malignancies: Duration of Response (DOR) for Participants With a Response of PR or Better

    Duration of Response (DOR) is defined as the time from the date of the participant's documented first response of PR or better to the date of documented disease progression or death due to the disease, whichever occurs first.

    Measured: Up to approximately 2 years

  3. Dose Escalation in Participants With R/R B-cell Malignancies: Time to Response (TTR)

    Time to response, defined as the length of time from the date of first dose of study drug to the date of first response of PR or better per disease-specific response criteria.

    Measured: Up to approximately 2 years

  4. Monotherapy Dose Expansion in Participants With R/R B-cell Malignancies: Achievement of a Response of PR or Better

    Partial response (PR) as per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) , Lugano, International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria in protocol.

    Measured: Up to approximately 2 years

  5. Monotherapy Dose Expansion in Participants With R/R B-cell Malignancies: Duration of Response (DOR) for Participants With a Response of PR or Better

    Duration of Response (DOR) is defined as the time from the date of the participant's documented first response of PR or better to the date of documented disease progression or death due to the disease, whichever occurs first.

    Measured: Up to approximately 2 years

  6. Monotherapy Dose Expansion in Participants With R/R B-cell Malignancies: Time to Response (TTR)

    Time to response, defined as the length of time from the date of first dose of study drug to the date of first response of PR or better per disease-specific response criteria.

    Measured: Up to approximately 2 years

  7. Combination Dose Expansion in Participants With CLL/SLL: Achievement of Bone Marrow Undetectable Minimal Residual Disease (uMRD)

    Undetectable minimal residual disease (uMRD) is described as less than one myeloma cell per million bone marrow cells.

    Measured: Up to approximately 6 months

  8. Combination Dose Expansion in Participants With CLL/SLL: Achievement of Bone Marrow Undetectable Minimal Residual Disease (uMRD)

    Undetectable minimal residual disease (uMRD) is described as less than one myeloma cell per million bone marrow cells.

    Measured: Up to approximately 1 Year

  9. Combination Dose Expansion in Participants With CLL/SLL: Percentage of Participants With Achievement of Peripheral Blood uMRD

    Peripheral blood Undetectable minimal residual disease (uMRD) is described as less than one CLL cell per 10,000 leukocytes (or below 10^-4) or as specified in the protocol.

    Measured: Up to approximately 96 weeks

  10. Combination Dose Expansion in Participants With CLL/SLL: Duration of Response for Participants With a Response of PR or Better

    Duration of response is defined as the time from the initial objective response to disease progression or death, whichever occurs first.

    Measured: Up to approximately 2 years

  11. Combination Dose Expansion in Participants With CLL/SLL: Time to Response

    Time to response is defined by the time between the date of the first drug intake and the date of the first assessment having documented the response.

    Measured: Up to approximately 2 years

  12. Combination Dose Expansion in Participants with CLL/SLL: Progression Free Survival

    Progression free survival (PFS) is defined as the duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first.

    Measured: Approximately 2 years after study drug discontinuation

  13. Combination Dose Expansion in Participants With CLL/SLL: Overall Survival

    Overall Survival is defined as the number of days from the date the participant was randomized to the date of death.

    Measured: Approximately 2 years after study drug discontinuation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2021
  2. Study start27 Apr 2021
  3. Primary completion11 Jan 2023
  4. Study completion11 Jan 2023

Why it stopped: Strategic considerations

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04804254
Sponsor's protocol ID
M20-208
Other IDs
2020-005196-12
Status last verified
Jan 2023
First submitted
16 Mar 2021
Last updated
3 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABBV-623 and ABBV-992 in people with B-cell Lymphoma, run by AbbVie at 5 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Israel, Turkey (Türkiye), Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Strategic considerations). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events (AEs) (time frame: Up to approximately 25 months.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04804254.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in