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Birinapant

Phase 1Small molecule

TTetraLogic Pharmaceuticals

1

Indications

12

Total Trials

1

Active Trials

0

Competitors

Pipeline

Status by Indication[3][1]

Indication

Locally Recurrent Head and Neck Squamous Cell CarcinomaActive, not recruiting

Locally Recurrent Head and Neck Squamous Cell CarcinomaPhase 1

Active, not recruiting

Timeline

Expected Milestones

Q3 2027

Phase 1Active, not recruiting

Locally Recurrent Head and Neck Squamous Cell Carcinoma

NCT03803774

Clinical

Trials by Indication[1]

MDS1 trial

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

Terminated·TTetraLogic Pharmaceuticals·Phase 2·NCT02147873·118 enrolled

Refractory1 trial

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

Completed·TTetraLogic Pharmaceuticals·Phase 1/2·NCT01828346·21 enrolled

Pembrolizumab1 trial

Dose-escalation Study of Birinapant and Pembrolizumab in Solid Tumors

Terminated·MMedivir·Phase 1/2·NCT02587962·34 enrolled

Acute Lymphoblastic Leukemia1 trial

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

Terminated·—·Phase 1/2·NCT01486784·27 enrolled

Peritoneal Cancer1 trial

Birinapant for Advanced Ovarian, Fallopian Tube, and Peritoneal Cancer

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT01681368·11 enrolled

7 more indications

Lymphoma1 trial

Dose Escalation Safety Study of TL32711 in Adults With Refractory Solid Tumors or Lymphoma

Completed·TTetraLogic Pharmaceuticals·Phase 1·NCT00993239·50 enrolled

Primary Peritoneal Cancer1 trial

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

Withdrawn·JJonsson Comprehensive Cancer Center·Phase 1/2·NCT02756130

Advanced or Metastatic Solid Tumors1 trial

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

Completed·TTetraLogic Pharmaceuticals·Phase 1/2·NCT01188499·176 enrolled

Ovarian Cancer1 trial

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

Completed·TTetraLogic Pharmaceuticals·Phase 1·NCT01940172·27 enrolled

Newly Diagnosed1 trial

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

Terminated·IIGM Biosciences, Inc.·Phase 1·NCT04553692·272 enrolled

Chronic Hepatitis1 trial

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

Terminated·TTetraLogic Pharmaceuticals·Phase 1·NCT02288208·7 enrolled

Locally Recurrent Head and Neck Squamous Cell Carcinoma1 trial

Birinapant and Intensity Modulated Re-Irradiation Therapy (IMRRT) for Locoregionally Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT03803774·13 enrolled

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for Birinapant. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Birinapant compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Birinapant. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — TetraLogic Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 1[1]
Company: TTetraLogic Pharmaceuticals

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