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
Public ClinicalTrials.gov record NCT05753501. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 will include a dose escalation phase to determine the maximum administered dose (MAD)/Maximum tolerated dose (MTD) of ABBV-101. Dose expansion part 2A will follow to further determine the safety and change in disease activity in participants with first line treatment (1L\[non-US only\]), second line or later of treatment (2L)+ CLL/SLL or third line or later of treatment (3L+) non-GCB DLBCL receiving ABBV-101 alone. Dose expansion Part 2B (non-US only) will follow to determine the safety and change in disease activity in participants with 1L or 2L+ CLL/SLL receiving ABBV-101 in combination with oral venetoclax. Approximately 390 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 100 month study duration. In the dose expansion phase of the study participants receive oral ABBV-101 alone or oral ABBV-101 at a dose determined in the dose escalation phase in combination with oral venetoclax, as part of the approximately 100 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.
Study identification
- NCT ID
- NCT05753501
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 135 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 8, 2023
- Primary completion
- Feb 28, 2031
- Completion
- Feb 28, 2031
- Last update posted
- Aug 5, 2026
2023 – 2031
United States locations
- U.S. sites
- 14
- U.S. states
- 11
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Oncology - Tucson - Wilmot Road /ID# 252351 | Tucson | Arizona | 85711 | — |
| UC Irvine Medical Center /ID# 263020 | Orange | California | 92868-3201 | — |
| Stanford University - Palo Alto /ID# 249683 | Palo Alto | California | 94304 | — |
| Rocky Mountain Cancer Centers - Lone Tree /ID# 252237 | Lone Tree | Colorado | 80124 | — |
| Northwestern University Feinberg School of Medicine /ID# 249347 | Chicago | Illinois | 60611-2927 | — |
| Beth Israel Deaconess Medical Center /ID# 249302 | Boston | Massachusetts | 02215-5400 | — |
| Rutgers Cancer Institute of New Jersey /ID# 249323 | New Brunswick | New Jersey | 08901 | — |
| New York Oncology Hematology - Albany Cancer Center /ID# 252240 | Albany | New York | 12206-5013 | — |
| Northwell Health - Monter Cancer Center /ID# 250422 | Lake Success | New York | 11042 | — |
| University of Rochester Medical Center /ID# 249324 | Rochester | New York | 14642-0001 | — |
| UC Health - Cincinnati /ID# 249299 | Cincinnati | Ohio | 45267-2800 | — |
| Oncology Assoc. of Oregon PC - WVCI and Research Ctr - Springfield /ID# 249309 | Eugene | Oregon | 97401-6036 | — |
| University of Pennsylvania /ID# 250341 | Philadelphia | Pennsylvania | 19104 | — |
| MD Anderson Cancer Center /ID# 249293 | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 37 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05753501, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 5, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05753501 live on ClinicalTrials.gov.