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Trials |  |
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- | eftozanermin alfa (ABBV-621) / AbbVie, Apogenix
Trial completion date, Trial primary completion date, Combination therapy: Study to Determine Recommended Phase 2 Dose of Intravenous (IV) Eftozanermin Alfa in Combination With IV or Subcutaneous (SC) Bortezomib and Oral Dexamethasone Tablet and to Assess Change in Disease Symptoms in Adult Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Aug 13, 2024
P1, N=40, Active, not recruiting, Sponsor: AbbVie
Trial completion date: Jul 2024 --> Jan 2025 | Trial primary completion date: Jul 2024 --> Jan 2025
- | eftozanermin alfa (ABBV-621) / AbbVie, Apogenix
Phase classification, Trial completion date, Trial primary completion date, Combination therapy: Study to Determine Recommended Phase 2 Dose of Intravenous (IV) Eftozanermin Alfa in Combination With IV or Subcutaneous (SC) Bortezomib and Oral Dexamethasone Tablet and to Assess Change in Disease Symptoms in Adult Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Jun 17, 2024
P1, N=40, Active, not recruiting, Sponsor: AbbVie
Trial completion date: Jul 2024 --> Jan 2025 | Trial primary completion date: Jul 2024 --> Jan 2025 Phase classification: P1b --> P1 | Trial completion date: Oct 2024 --> Jul 2024 | Trial primary completion date: Oct 2024 --> Jul 2024
- | eftozanermin alfa (ABBV-621) / AbbVie, Apogenix
Trial completion date, Trial primary completion date, Combination therapy: Study to Determine Recommended Phase 2 Dose of Intravenous (IV) Eftozanermin Alfa in Combination With IV or Subcutaneous (SC) Bortezomib and Oral Dexamethasone Tablet and to Assess Change in Disease Symptoms in Adult Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Apr 4, 2023
P1b, N=40, Active, not recruiting, Sponsor: AbbVie
Phase classification: P1b --> P1 | Trial completion date: Oct 2024 --> Jul 2024 | Trial primary completion date: Oct 2024 --> Jul 2024 Trial completion date: Aug 2023 --> Oct 2024 | Trial primary completion date: Aug 2023 --> Oct 2024
- | eftozanermin alfa (ABBV-621) / AbbVie, Apogenix, TLY012 / D&D Pharmatech, ONC201 / Chimerix
Journal: Therapeutic targeting of TRAIL death receptors. (Pubmed Central) - Mar 2, 2023
In this review, we summarize the successes and shortcomings of first- and second-generation TRAIL pathway-based therapies, concluding with an overview of the discovery and clinical introduction of ONC201, a compound with a unique mechanism of action that represents a new generation of TRAIL pathway-based approaches. We discuss preclinical and clinical findings in different tumor types and provide a unique perspective on translational directions of the field.
- | Venclexta (venetoclax) / Roche, AbbVie, eftozanermin alfa (ABBV-621) / AbbVie, Apogenix
Preclinical, Journal, IO biomarker: Activity of eftozanermin alfa plus venetoclax in preclinical models and patients with acute myeloid leukemia. (Pubmed Central) - Feb 1, 2023
P1
These data indicate that combination therapy with eftoza plus venetoclax to simultaneously activate the extrinsic and intrinsic apoptosis-signaling pathways may improve clinical benefit compared with venetoclax monotherapy in relapsed/refractory AML with an acceptable toxicity profile. Registered at www.clinicaltrials.gov as NCT03082209.
- || eftozanermin alfa (ABBV-621) / AbbVie, Apogenix
Enrollment closed, Combination therapy: Study to Determine Recommended Phase 2 Dose of Intravenous (IV) Eftozanermin Alfa in Combination With IV or Subcutaneous (SC) Bortezomib and Oral Dexamethasone Tablet and to Assess Change in Disease Symptoms in Adult Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Oct 14, 2022
P1b, N=40, Active, not recruiting, Sponsor: AbbVie
Registered at www.clinicaltrials.gov as NCT03082209. Recruiting --> Active, not recruiting
- || eftozanermin alfa (ABBV-621) / AbbVie, Apogenix
P1 data, Clinical Trial,Phase I, Journal, Monotherapy: Eftozanermin alfa (ABBV-621) monotherapy in patients with previously treated solid tumors: findings of a phase 1, first-in-human study. (Pubmed Central) - Jul 23, 2022
P1
The 7.5-mg/kg QW regimen was selected for future studies on the basis of safety findings, pharmacodynamic effects, and biomarker modulations. (Trial registration number: NCT03082209 (registered: March 17, 2017)).
- | eftozanermin alfa (ABBV-621) / AbbVie, Apogenix
Trial primary completion date, Combination therapy: Study to Determine Recommended Phase 2 Dose of Intravenous (IV) Eftozanermin Alfa in Combination With IV or Subcutaneous (SC) Bortezomib and Oral Dexamethasone Tablet and to Assess Change in Disease Symptoms in Adult Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Jul 14, 2022
P1b, N=40, Recruiting, Sponsor: AbbVie
(Trial registration number: NCT03082209 (registered: March 17, 2017)). Trial primary completion date: Jan 2023 --> Aug 2023
- | eftozanermin alfa (ABBV-621) / AbbVie, Apogenix
Trial completion date, Combination therapy: Study to Determine Recommended Phase 2 Dose of Intravenous (IV) Eftozanermin Alfa in Combination With IV or Subcutaneous (SC) Bortezomib and Oral Dexamethasone Tablet and to Assess Change in Disease Symptoms in Adult Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - May 3, 2022
P1b, N=40, Recruiting, Sponsor: AbbVie
Trial primary completion date: Jan 2023 --> Aug 2023 Trial completion date: Jan 2023 --> Aug 2023
- ||| eftozanermin alfa (ABBV-621) / AbbVie, Apogenix
Trial completion: A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously-Treated Solid Tumors and Hematologic Malignancies (clinicaltrials.gov) - Mar 25, 2022
P1, N=153, Completed, Sponsor: AbbVie
Trial completion date: Jan 2023 --> Aug 2023 Active, not recruiting --> Completed
- | eftozanermin alfa (ABBV-621) / AbbVie, Apogenix
Journal: Hexavalent TRAIL fusion protein eftozanermin alfa optimally clusters apoptosis-inducing TRAIL receptors to induce on-target antitumor activity in solid tumors. (Pubmed Central) - Dec 16, 2021
P1
To build upon the OR of ABBV-621 monotherapy in CRC (45%; 10/22) and pancreatic cancer (35%; 7/20), we subsequently demonstrated that inherent resistance to ABBV-621 treatment could be overcome in combination with chemotherapeutics or with selective inhibitors of BCL-XL. In summary, these data provide a pre-clinical rationale for the ongoing Phase-1 clinical trial (NCT03082209) evaluating the activity of ABBV-621 in cancer patients.
- || eftozanermin alfa (ABBV-621) / AbbVie, Apogenix
Enrollment closed, Trial completion date, Trial primary completion date: A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously-Treated Solid Tumors and Hematologic Malignancies (clinicaltrials.gov) - Oct 20, 2021
P1, N=153, Active, not recruiting, Sponsor: AbbVie
In summary, these data provide a pre-clinical rationale for the ongoing Phase-1 clinical trial (NCT03082209) evaluating the activity of ABBV-621 in cancer patients. Recruiting --> Active, not recruiting | Trial completion date: Aug 2022 --> Feb 2022 | Trial primary completion date: Aug 2022 --> Feb 2022
- pevonedistat (MLN4924) / Takeda, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
[VIRTUAL] The combinatorial activity of Eftozanermin ABBV621, a novel and potent TRAIL receptor agonist fusion protein, in pre-clinical models of hematologic malignancies () - Mar 11, 2021 - Abstract #AACR2021AACR_2036;
P1
Additionally, synergistic activity was observed with ABBV-621 with either bendamustine (BED) or rituximab (RTX) alone, or BED/RTX together...The pre-clinical data presented here support expanding the indications and settings where ABBV-621 may have utility. A clinical trial assessing the activity of ABBV-621 in combination with bortezomib and dexamethasone in R/R MM patients is planned.
- || eftozanermin alfa (ABBV-621) / AbbVie, Apogenix
Enrollment open, Combination therapy: Study to Determine Recommended Phase 2 Dose of Intravenous (IV) Eftozanermin Alfa in Combination With IV or Subcutaneous (SC) Bortezomib and Oral Dexamethasone Tablet and to Assess Change in Disease Symptoms in Adult Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Dec 3, 2020
P1b, N=40, Recruiting, Sponsor: AbbVie
A clinical trial assessing the activity of ABBV-621 in combination with bortezomib and dexamethasone in R/R MM patients is planned. Not yet recruiting --> Recruiting
- Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
[VIRTUAL] The Combinatorial Activity of Eftozanermin (ABBV-621), a Novel and Potent TRAIL Receptor Agonist Fusion Protein, in Pre-Clinical Models of Hematologic Malignancies () - Nov 5, 2020 - Abstract #ASH2020ASH_5135;
P1
Additionally, synergistic activity was observed with ABBV-621 with either bendamustine (BED) or rituximab (RTX) alone, or BED/RTX together...A clinical trial assessing the activity of ABBV-621 in combination with bortezomib and dexamethasone in R/R MM patients is planned...The design, study conduct, and financial support for this research were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the publication.
- bortezomib / Generic mfg.
[VIRTUAL] A Phase 1b, Open-Label Study of Eftozanermin Alfa in Combination with Bortezomib and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma (Poster Hall (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_1214;
P1
Biomarker analyses may include evaluation of death receptor 4/5 expression, chromosomal abnormalities, and minimal residual disease status. Approximately 20 sites in 6 countries are planned to be involved in the study, which is anticipated to start in September 2020.
- Darzalex IV (daratumumab) / J&J
[VIRTUAL] Ex Vivo Drug Sensitivity and Functional Genomics Platform Identifies Novel Combinations Targeting Intrinsic and Extrinsic Apoptotic Signaling Pathways in Multiple Myeloma (Poster Hall (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_1134;
An ex vivo functional genomic screen of MM patient specimens demonstrated the usefulness of this approach to identify candidate drugs and potential predictive biomarkers for continued evaluation in clinical trials. This approach confirmed known mechanisms of drug sensitivity and identified new ones, including a novel characterized immune-mediated synergy between Ven and daratumumab, and potential combination strategy for Eftoza and proteasome inhibitors.
- || eftozanermin alfa (ABBV-621) / AbbVie, Apogenix
New P1 trial, Combination therapy: Study to Determine Recommended Phase 2 Dose of Intravenous (IV) Eftozanermin Alfa in Combination With IV or Subcutaneous (SC) Bortezomib and Oral Dexamethasone Tablet and to Assess Change in Disease Symptoms in Adult Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Sep 29, 2020
P1b, N=40, Not yet recruiting, Sponsor: AbbVie
- eftozanermin alfa (ABBV-621) / AbbVie, Apogenix
[VIRTUAL] First-In-Human Study of a Trail Receptor Agonist Fusion Protein, Eftozanermin Alfa, in Patients with Relapsed/Refractory Acute Myeloid Leukemia and Diffuse Large B-Cell Lymphoma () - Sep 14, 2020 - Abstract #SOHO2020SOHO_352;
Antitumor activity was observed in patients with AML treated with eftoza-VEN at 3.75- or 7.5-mg/kg doses. Abstract was previously published at EHA25.
- | ABBV-621 / AbbVie, Apogenix
Preclinical, Journal: Enhancing radiation response by a second-generation TRAIL receptor agonist using a new in vitro organoid model system. (Pubmed Central) - Jun 28, 2020
Lastly, in the long-term survival assays, we demonstrated a radiosensitizing effect of APG-880 with dose enhancement factors between 1.3 and 1.5. In a new, clinically relevant CRC-organoid model system we demonstrated a more than additive combined effect between the second-generation TRAIL receptor agonist APG-880 and radiation.
- Venclexta (venetoclax) / Roche, AbbVie
[VIRTUAL] FIRST-IN-HUMAN STUDY OF A TRAIL RECEPTOR AGONIST FUSION PROTEIN, EFTOZANERMIN ALFA, IN PATIENTS WITH RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA AND DIFFUSE LARGE B-CELL LYMPHOMA () - May 16, 2020 - Abstract #EHA2020EHA_796;
P1
Venetoclax (VEN) is a potent, highly selective BCL-2 inhibitor approved for treatment of adults with chronic lymphocytic leukemia and newly diagnosed acute myeloid leukemia (AML)...Antitumor activity was observed in pts with AML treated with eftoza-VEN at 3.75- or 7.5-mg/kg doses. Updated data will be presented at the meeting.
- ABBV-621 / AbbVie, Apogenix
[VIRTUAL] Pharmacodynamic effects in blood and tumor tissue of eftozanermin alfa, a tumor necrosis factor-related apoptosis-inducing ligand receptor agonist. () - Apr 29, 2020 - Abstract #ASCO2020ASCO_3816;
P1
Pharmacodynamic effect of eftoza was successfully demonstrated in blood and tumor tissue, including induction of apoptosis and modulation of PI3K and MEK signaling pathways. Research Funding: AbbVie, Inc.
- || eftozanermin alfa (ABBV-621) / AbbVie, Apogenix
Trial completion date, Trial primary completion date: A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously-Treated Solid Tumors and Hematologic Malignancies (clinicaltrials.gov) - Apr 22, 2020
P1, N=205, Recruiting, Sponsor: AbbVie
Research Funding: AbbVie, Inc. Trial completion date: Dec 2021 --> Aug 2022 | Trial primary completion date: Feb 2021 --> Aug 2022
- Venclexta (venetoclax) / Roche, AbbVie
First-in-Human Study of Abbv-621, a TRAIL Receptor Agonist Fusion Protein, in Patients (Pts) with Relapsed/Refractory (RR) Acute Myeloid Leukemia (AML) and Diffuse Large B-Cell Lymphoma (DLBCL) (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_5654;
P1
Venetoclax (VEN), a highly selective small-molecule BCL2 inhibitor, has shown antitumor activity in combination therapy in AML and DLBCL . ABBV-621 was tolerated and showed antitumor activity in combination with VEN in pts with RR AML.
- ABBV-621 / AbbVie, Apogenix
First-in-human study of ABBV-621 in patients (pts) with previously treated sold tumours: Dose-optimization cohorts (Poster Area (Hall 4)) - Sep 11, 2019 - Abstract #ESMO2019ESMO_1480;
P1
Clinical trial identification: NCT03082209. Legal entity responsible for the study: AbbVie Inc.
- | eftozanermin alfa (ABBV-621) / AbbVie, Apogenix
Trial completion date, Trial primary completion date: A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously-Treated Solid Tumors and Hematologic Malignancies (clinicaltrials.gov) - Aug 15, 2019
P1, N=205, Recruiting, Sponsor: AbbVie
Legal entity responsible for the study: AbbVie Inc. Trial completion date: Jul 2020 --> Dec 2021 | Trial primary completion date: Jul 2020 --> Feb 2021
- || eftozanermin alfa (ABBV-621) / AbbVie, Apogenix
Enrollment change, Trial completion date, Trial primary completion date: A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously-Treated Solid Tumors and Hematologic Malignancies (clinicaltrials.gov) - May 21, 2019
P1, N=155, Recruiting, Sponsor: AbbVie
Trial completion date: Jul 2020 --> Dec 2021 | Trial primary completion date: Jul 2020 --> Feb 2021 N=235 --> 155 | Trial completion date: Feb 2021 --> Jul 2020 | Trial primary completion date: Feb 2021 --> Jul 2020
- || eftozanermin alfa (ABBV-621) / AbbVie, Apogenix
Enrollment change: A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously-Treated Solid Tumors and Hematologic Malignancies (clinicaltrials.gov) - Mar 13, 2019
P1, N=235, Recruiting, Sponsor: AbbVie
N=235 --> 155 | Trial completion date: Feb 2021 --> Jul 2020 | Trial primary completion date: Feb 2021 --> Jul 2020 N=155 --> 235
- || eftozanermin alfa (ABBV-621) / AbbVie, Apogenix
Enrollment change: A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously-Treated Solid Tumors and Hematologic Malignancies (clinicaltrials.gov) - Apr 3, 2018
P1, N=92, Recruiting, Sponsor: AbbVie
N=155 --> 235 N=150 --> 92
- || eftozanermin alfa (ABBV-621) / AbbVie, Apogenix
Enrollment change: A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously-Treated Solid Tumors and Hematologic Malignancies (clinicaltrials.gov) - Feb 28, 2018
P1, N=150, Recruiting, Sponsor: AbbVie
N=150 --> 92 N=92 --> 150
- ||| eftozanermin alfa (ABBV-621) / AbbVie, Apogenix
New P1 trial: A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously-Treated Solid Tumors and Hematologic Malignancies (clinicaltrials.gov) - Mar 16, 2017
P1, N=92, Recruiting, Sponsor: AbbVie