A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously-Treated Solid Tumors and Hematologic Malignancies
NCT ID: NCT03082209
Last Updated: 2022-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
153 participants
INTERVENTIONAL
2017-03-20
2022-01-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Only chemotherapy combination (ABBV-621 + FOLFIRI) enrolling participants with RAS-mutant CRC who have received one prior line of therapy is open for enrollment.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Chemotherapy combination: ABBV-621 + FOLFIRI + Bevacizumab
Participants with KRAS-mutant CRC are administered with ABBV-621 in combination with bevacizumab plus FOLFIRI
ABBV-621
Intravenous (IV)
Bevacizumab
IV infusion
FOLFIRI
IV infusion
Chemotherapy combination: ABBV-621+FOLFIRI
Participants with RAS-mutant CRC who have received one prior line of therapy will be administered ABBV-621 in combination FOLFIRI.
ABBV-621
Intravenous (IV)
FOLFIRI
IV infusion
Dose Optimization: ABBV-621 + Venetoclax for AML
Additional participants with AML will be enrolled and will be treated with a combination of ABBV-621 and venetoclax.
ABBV-621
Intravenous (IV)
Venetoclax
tablet, oral
Dose Optimization: ABBV-621 Monotherapy for AML
Participants with Acute Myeloid Leukemia (AML) will be treated with ABBV-621 monotherapy.
ABBV-621
Intravenous (IV)
Dose Optimization: ABBV-621 + Venetoclax for DLBCL
Participants with diffuse large B-cell lymphoma (DLBCL) will be treated with a combination of ABBV-621 and venetoclax.
ABBV-621
Intravenous (IV)
Venetoclax
tablet, oral
Dose Optimization for Pancreatic Cancer
Participants with pancreatic cancer will be treated with single-agent ABBV-621 to enable selection of the recommended Phase 2 dose (RP2D).
ABBV-621
Intravenous (IV)
Dose Optimization for KRAS-mutant CRC
Participants with colorectal cancer (CRC) will be treated with single-agent ABBV-621 to enable selection of the RP2D.
ABBV-621
Intravenous (IV)
Dose Escalation
ABBV-621 via intravenous administration at escalating dose levels in participants with solid tumors including Non-Hodgkin Lymphoma (NHL).
ABBV-621
Intravenous (IV)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ABBV-621
Intravenous (IV)
Venetoclax
tablet, oral
Bevacizumab
IV infusion
FOLFIRI
IV infusion
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participant in dose escalation or dose optimization cohort must have received at least one prior systemic therapy, and must have relapsed or progressed after, or failed to respond to any/all available effective therapy or therapies.
* Participant in chemotherapy cohorts with CRC must have progressed after or failed to respond to initial systemic therapy.
* Must have measurable disease (by Response Evaluation Criteria In Solid Tumors \[RECIST\] 1.1 for those with solid tumors; by Lugano classification for those with NHL), except those with AML, who must have histologically confirmed relapsed or refractory disease.
* Must agree to provide the following samples for biomarker analysis:
* All participants: archived tumor tissue (if available).
* Participants in Dose Optimization (excluding AML): pre- and on-treatment fresh tissue biopsies. (Note: fresh tissue biopsies will be optional for participants with solid tumor or NHL in Dose Escalation and will be collected only if consent is provided)
* All participants with AML: pre- and on-treatment bone marrow aspirates (BMA)
* Participants in chemotherapy combination cohorts: participants must provide a fresh biopsy if an archival biopsy is not available
* Participant in chemotherapy cohorts with CRC must have confirmed RAS mutation
* Must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 - 2. Participants in chemotherapy combination cohorts must have ECOG Performance Score of 0 - 1.
* Must have adequate hematologic, renal and hepatic function.
Exclusion Criteria
* Presence of primary hepatobiliary malignancy, including cholangiocarcinoma or hepatocellular carcinoma, gallbladder carcinoma, cancer of ampulla of Vater.
* Receipt of any systemic anti-cancer agent, including investigational anti-cancer products, within 21 days prior to study drug administration or 3 half-lives, whichever is longer.
* Participant with a history of cirrhosis or other indication of significant possible hepatic dysfunction. Note: Those with non-alcoholic steatohepatitis (NASH) should be discussed with the AbbVie TA MD before enrollment.
* Participant with a positive diagnosis of hepatitis A, B, or C.
* Dose Optimization combination cohorts only: Prior receipt, at any time, of a BCL-2 inhibitor
* Dose Optimization combination cohorts only: Participant has received strong or moderate CYP3A inhibitors or inducers within 7 days prior to the initiation of study treatment.
* Dose Optimization combination cohorts only: Participant has malabsorption syndrome or other condition that precludes enteral route of administration.
* Dose Optimization combination cohorts only: Participant has promyelocytic leukemia (M3).
* CRC chemotherapy cohort only: Participant with minor surgical procedures, such as fine needle aspirations or core biopsies, within 7 days prior to first dose of study drug are excluded.
* Participants in CRC chemotherapy combination cohort only: cardiomyopathy, coronary/peripheral artery bypass graft, aneurysm or aneurysm repair, angioplasty, pulmonary hypertension, cerebrovascular accident or transient ischemic attack, within 1 year of first dose of study drug.
* Chemotherapy combination CRC participants only: Prior receipt of an irinotecan-based chemotherapy.
* Chemotherapy combination CRC participants only: Disease progression within 3-months of initiating first-line therapy.
* Chemotherapy combination CRC participants only: history of Gilbert's syndrome or UG1T1A1 genotypes.
* Chemotherapy combination with bevacizumab participants only: clinically significant conditions that may place the participant at higher risk with anti-angiogenic therapy.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AbbVie
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Yale University /ID# 158029
New Haven, Connecticut, United States
The University of Chicago Medical Center /ID# 158030
Chicago, Illinois, United States
Ingalls Memorial Hosp /ID# 171221
Harvey, Illinois, United States
Univ Michigan Med Ctr /ID# 207134
Ann Arbor, Michigan, United States
Rhode Island Hospital /ID# 171157
Providence, Rhode Island, United States
Vanderbilt University Medical Center /ID# 215000
Nashville, Tennessee, United States
MD Anderson Cancer Center /ID# 202187
Houston, Texas, United States
Millennium Oncology /ID# 214981
Houston, Texas, United States
South Texas Accelerated Research Therapeutics /ID# 160574
San Antonio, Texas, United States
Medical College of Wisconsin /ID# 171152
Milwaukee, Wisconsin, United States
National Cancer Center Hospital East /ID# 160596
Kashiwa-shi, Chiba, Japan
Yamagata University Hospital /ID# 200681
Yamagata, Yamagata, Japan
Erasmus Medisch Centrum /ID# 160869
Rotterdam, South Holland, Netherlands
Universitair Medisch Centrum Groningen /ID# 169748
Groningen, , Netherlands
Maastricht Universitair Medisch Centrum /ID# 214935
Maastricht, , Netherlands
Universitair Medisch Centrum Utrecht /ID# 169747
Utrecht, , Netherlands
Hospital Universitario Vall d'Hebron /ID# 170809
Barcelona, , Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 200106
Madrid, , Spain
Hospital Universitario HM Sanchinarro /ID# 165136
Madrid, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Biesdorf C, Guan X, Siddani SR, Hoffman D, Boehm N, Medeiros BC, Doi T, de Jonge M, Rasco D, Menon RM, Polepally AR. Pharmacokinetics and immunogenicity of eftozanermin alfa in subjects with previously-treated solid tumors or hematologic malignancies: results from a phase 1 first-in-human study. Cancer Chemother Pharmacol. 2024 Apr;93(4):329-339. doi: 10.1007/s00280-023-04613-9. Epub 2023 Nov 30.
Tahir SK, Calvo E, Carneiro BA, Yuda J, Shreenivas A, Jongen-Lavrencic M, Gort E, Ishizawa K, Morillo D, Biesdorf C, Smith M, Cheng D, Motwani M, Sharon D, Uziel T, Modi DA, Buchanan FG, Morgan-Lappe S, Medeiros BC, Phillips DC. Activity of eftozanermin alfa plus venetoclax in preclinical models and patients with acute myeloid leukemia. Blood. 2023 Apr 27;141(17):2114-2126. doi: 10.1182/blood.2022017333.
LoRusso P, Ratain MJ, Doi T, Rasco DW, de Jonge MJA, Moreno V, Carneiro BA, Devriese LA, Petrich A, Modi D, Morgan-Lappe S, Nuthalapati S, Motwani M, Dunbar M, Glasgow J, Medeiros BC, Calvo E. Eftozanermin alfa (ABBV-621) monotherapy in patients with previously treated solid tumors: findings of a phase 1, first-in-human study. Invest New Drugs. 2022 Aug;40(4):762-772. doi: 10.1007/s10637-022-01247-1. Epub 2022 Apr 25.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-003887-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M15-913
Identifier Type: -
Identifier Source: org_study_id