Birinapant

DRUG10 trials

Sponsors

TetraLogic Pharmaceuticals, Abramson Cancer Center at Penn Medicine, Medivir, Jonsson Comprehensive Cancer Center, National Cancer Institute (NCI)

Conditions

Acute Myelogenous LeukemiaAcute Myeloid LeukemiaCancerChondrosarcomaChronic Lymphocytic LeukemiaChronic Myelomonocytic Leukemia (CMML)Colorectal CancerHepatitis B

Phase 1

Dose Escalation, Combination Chemotherapy Safety Study of Birinapant (TL32711), in Subjects With Advanced or Metastatic Solid Tumors

CompletedNCT01188499

TetraLogic PharmaceuticalsCancer

Start: 2010-10-31End: 2014-03-31Updated: 2016-05-30

A Phase I-II Open Label Non-Randomized Study Using TL32711 for Patients With Acute Myelogenous Leukemia, Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia

TerminatedNCT01486784

Abramson Cancer Center at Penn MedicineAcute Myelogenous Leukemia

Start: 2011-11-30End: 2015-04-30Updated: 2021-06-24

Birinapant With 5-azacitidine in MDS Subjects Who Are Naïve, Have Relapsed or Are Refractory to 5-azacitidine Therapy

CompletedNCT01828346

TetraLogic PharmaceuticalsMyelodysplastic Syndrome

Start: 2013-06-30End: 2015-11-30Updated: 2016-04-21

Study of Birinapant in Combination With Conatumumab in Subjects With Relapsed Ovarian Cancer

CompletedNCT01940172

TetraLogic PharmaceuticalsRelapsed Epithelial Ovarian Cancer, Relapsed Fallopian Tube Cancer, Relapsed Primary Peritoneal Cancer

Start: 2013-11-30End: 2015-12-31Updated: 2016-01-14

Phase I Safety and Tolerability Study of Birinapant in Chronic Hepatitis B

TerminatedNCT02288208

TetraLogic PharmaceuticalsHepatitis B

Start: 2014-11-30End: 2015-05-31Updated: 2016-02-05

Dose-escalation Study of Birinapant and Pembrolizumab in Solid Tumors

TerminatedNCT02587962

MedivirSolid Tumors

Start: 2017-08-04End: 2020-02-17Updated: 2021-01-14

Birinapant and Carboplatin in Treating Patients and Targeting Recurrent High Grade Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (HGSOC)

WithdrawnNCT02756130

Jonsson Comprehensive Cancer CenterHigh Grade Fallopian Tube Serous Adenocarcinoma, High Grade Ovarian Serous Adenocarcinoma, Primary Peritoneal High Grade Serous Adenocarcinoma +3

Start: 2018-08-01End: 2021-02-01Updated: 2025-05-13

Birinapant and Intensity Modulated Re-Irradiation Therapy in Treating Patients With Locally Recurrent Head and Neck Squamous Cell Carcinoma

Active, not recruitingNCT03803774

National Cancer Institute (NCI)Locally Recurrent Head and Neck Squamous Cell Carcinoma, Nasopharyngeal Squamous Cell Carcinoma, Sinonasal Squamous Cell Carcinoma

Start: 2019-09-25End: 2026-07-09Updated: 2025-11-07

Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants with Relapsed, Refractory, or Newly Diagnosed Cancers

TerminatedNCT04553692

IGM Biosciences, Inc.Acute Myeloid Leukemia, Chondrosarcoma, Chronic Lymphocytic Leukemia +5

Start: 2020-09-23End: 2025-01-20Updated: 2025-03-28

Phase 2

Study of Azacitidine With or Without Birinapant in Subjects With MDS or CMMoL

TerminatedNCT02147873

TetraLogic PharmaceuticalsChronic Myelomonocytic Leukemia (CMML), Myelodysplastic Syndrome (MDS)

Start: 2014-06-30End: 2016-06-30Updated: 2016-10-20

Related Papers

Synergistic effects of Smac mimetic APG-1387 with anti-PD-1 antibody are attributed to increased CD3 + NK1.1 + cell recruitment secondary to induction of cytokines from tumor cells

Cancer Cell International2024-05-243 citations

Abstract 1899: Novel combinations of aplitabart, a DR5 agonist IgM antibody, with ADCs or chemotherapeutic agents lead to robust anti-tumor responses in solid tumor models

Cancer Research2024-03-221 citations

Abstract C031: A randomized Phase 1b study of IGM-8444 in combination with FOLFIRI + bevacizumab compared to FOLFIRI + bevacizumab alone in second line metastatic colorectal cancer

Molecular Cancer Therapeutics2023-12-012 citations

Abstract A137: Pharmacokinetics and pharmacodynamics of IGM-8444, a first-in-class engineered pentameric DR5-targeting agonist IgM monoclonal antibody, in patients with R/R and newly diagnosed cancers

Molecular Cancer Therapeutics2023-12-01

Abstract 6123: Characterization of the synergistic tumor cytotoxicity of agonistic DR5 IgM antibody IGM-8444 with chemotherapeutic agents

Cancer Research2023-04-04

Abstract 1068: Anti-DR5 agonist IgM antibody IGM-8444 combined with SMAC mimetic birinapant induces strong synergistic tumor cytotoxicity

Cancer Research2022-06-152 citations

Abstract 52: Mechanistic evaluation of anti-DR5 IgM antibody IGM-8444 with potent tumor cytotoxicity, without in vitro hepatotoxicity

Cancer Research2021-07-011 citations

Determination of the recommended phase II dose of birinapant in combination with pembrolizumab: Results from the dose-escalation phase of BPT-201.

Journal of Clinical Oncology2019-05-207 citations

A phase 1/2 study with birinapant in combination with pembrolizumab.

Journal of Clinical Oncology2018-05-204 citations

A phase 2 study of azacitidine (5-AZA) with or without birinapant in subjects with higher risk myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML).

Journal of Clinical Oncology2016-05-2010 citations

A phase 1b, open-label, non-randomized multicenter study of birinapant in combination with conatumumab in subjects with relapsed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

Journal of Clinical Oncology2015-05-207 citations