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Birinapant

Phase 2

Cancer | Small Molecules | Oncology |TetraLogic Pharmaceuticals Corporation|Trials Updated: May 30, 2016

Birinapant development status

Highest phase Phase 2 (NCT02147873)
Phase scored for TLOGPhase 1/2
Registered trials 8 across 4 sponsors since Aug 2010

Birinapant target and mechanism

Molecular targetBIRC3, BIRC2
Target classInhibitor
ModalitySmall Molecules
ChEMBLCHEMBL3039522

Also known as Birinapant (TL32711), TL32711

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials4
Total Enrollment274

FDA Designations

No designations recorded

Birinapant clinical trials

Birinapant · 4 trials · 5 indications

Phase 1/2 2Phase 1 2
NCT01828346Birinapant With 5-azacitidine in MDS Subjects Who Are Naïve, Have Relapsed or Are Refractory to 5-azacitidine TherapyMyelodysplastic Syndrome
COMPLETED21 Analytics
NCT01188499Dose Escalation, Combination Chemotherapy Safety Study of Birinapant (TL32711), in Subjects With Advanced or Metastatic Solid TumorsCancer
COMPLETED176 Analytics
PHASE1/PHASE2COMPLETED
Birinapant With 5-azacitidine in MDS Subjects Who Are Naïve, Have Relapsed or Are Refractory to 5-azacitidine Therapy
Myelodysplastic Syndrome
NCT0182834621
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PHASE1/PHASE2COMPLETED
Dose Escalation, Combination Chemotherapy Safety Study of Birinapant (TL32711), in Subjects With Advanced or Metastatic Solid Tumors
Cancer
NCT01188499176
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Study Endpoints

Primary Endpoints

Maximum tolerated dose (MTD)
6 months
Number of Subjects With Adverse Events as a Measure of Safety and Tolerability
1 Cycle (3-4 weeks)

Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters

Determination of Maximum Tolerated Dose (MTD)
28 Days
Define the MTD
4 weeks (Cycle 1)

Secondary Endpoints

Evaluation of Anti-tumor Efficacy
Every 2 cycles
Evaluation of Pharmacokinetics and Translational Biomarkers
Cycle 1 and Cycle 2
Clinical response as measured by RECIST (v1.1) criteria, CA 125 (GCIG criteria) and progression-free survival (PFS).
Up to 4 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TreatmentEXPERIMENTAL5-Azacitidine plus birinapant
Carboplatin/Paclitaxel + BirinapantEXPERIMENTALCarboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + birinapant (TL32711) once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).
Irinotecan + BirinapantEXPERIMENTALIrinotecan (350 mg/m2/IV) once every 3 (q3) weeks + birinapant (TL32711) once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).
Docetaxel + BirinapantEXPERIMENTALDocetaxel (75 mg/m2/IV) once every 3 (q3) weeks + birinapant (TL32711) once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).
Gemcitabine + BirinapantEXPERIMENTALGemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + birinapant (TL32711) once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).
Liposomal Doxorubicin + BirinapantEXPERIMENTALLiposomal doxorubicin (40 mg/m2/IV) every 4 weeks + birinapant (TL32711) once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).
Birinapant with ConatumumabEXPERIMENTAL -
Birinapant (TL32711)EXPERIMENTAL -

Interventions

NameTypeDescription
BirinapantDRUGDose escalation part: (Drug escalation dose levels) * Dose Level (1) - 13mg/m2 (twice a week for 3 of 4 weeks) * Dose Level (-1) - 11 mg/m2 (twice a week for 3 of 4 weeks) * Dose Level (2) - 13mg/m2 (twice weekly x 4 weeks) * Dose Level (3a) - 17mg/m2 (twice weekly × 4 weeks)OR * Dose Level (3b) - 17mg/m2 (twice a week for 3 of 4 weeks)
5-AzacitidineDRUGDose Level (0) - 75mg/m2 daily
ConatumumabDRUG10 mg/kg IV on Day 1 and 15 of each cycle
Birinapant (TL32711)DRUG30 minute intravenous (IV) infusion administered once weekly for three consecutive weeks followed by a one week off (Cycle) repeated every 4 weeks as tolerated
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Men or women more than 18 years of age. * Patients with high-risk Myelodysplastic Syndrome * Performance status of greater or equal to 2 by the Eastern Cooperative Oncology Group (ECOG) scale. * Subjects with high-risk MDS who are naïve to 5-Azacitidine or have previously rece...

Countries:United States
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Competitive Landscape -Cancer 13 trials

Top 5 of 9 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN1PHASE2Durvalumab
Nanobiotix SA Sponsored ADRNBTX1PHASE1NBTXR3
Olema Oncology, Inc.OLMA1PHASE1OP-3136, Palazestrant
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
Pfizer Inc.PFE1N/APalbociclib
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