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ABT-414

Phase 1

Glioblastoma Multiforme | Small molecule | Oncology |AbbVie Inc.|Last Updated: Sep 3, 2020

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment202

FDA Designations

No designations recorded

Clinical trial landscape

ABT-414 · 3 trials · 3 indications

Phase 1 3
NCT02590263Study Evaluating ABT-414 in Japanese Subjects With Malignant GliomaMalignant Glioma
COMPLETED53 Analytics
NCT01800695Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma MultiformeGlioblastoma Multiforme
COMPLETED202 Analytics
NCT01741727A Study of ABT-414 in Subjects With Solid TumorsSquamous Cell Tumors
COMPLETED57 Analytics
PHASE1COMPLETED
Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma
Malignant Glioma
NCT0259026353
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PHASE1COMPLETED
Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme
Glioblastoma Multiforme
NCT01800695202
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PHASE1COMPLETED
A Study of ABT-414 in Subjects With Solid Tumors
Squamous Cell Tumors
NCT0174172757
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Study Endpoints

Primary Endpoints

Percentage of participants with adverse events
At each visit for approximately 4 years
Number of Dose Limiting Toxicities
At each visit for approximately 1 year

Measurement by clinical lab results, vital signs, physical exam and electrocardiogram (ECG) during the Phase 1 portion of the study.

Progression-free survival
At each visit for approximately 1 year

Time to progression-free survival is defined as the number of days from the date of first dose to the date of earliest disease progression based on Response Assessment in Neuro-Oncology (RANO) criteria or to the date of death, if disease progression does not occur (except Arm B and Arm C of Phase 1 portion).

Area under the plasma concentration-time curve (AUC) of ABT-414
Multiple time points in Cycles 1, 2 and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment for approximately 1 year for recurrent subjects and in every week of Day 1 until Week 7 and end of treatment for the newly diagnosed subjects

Assessed during the Phase 1 portion of the study, the area under the plasma concentration-time curve (AUC) is a method of measurement to determine the total exposure of a drug in blood plasma.

Maximum plasma concentration (Cmax) of ABT-414
Multiple time points in Cycles 1, 2 and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment for approximately 1 year for recurrent subjects and in every week of Day 1 until Week 7 and end of treatment for the newly diagnosed subjects

Assessed during the Phase 1 portion of the study, the maximum plasma concentration (Cmax) is the highest concentration that a drug achieves in the blood after administration in a dosing interval.

Number and percentage of participants with adverse events
Every week for an expected average of 34 weeks

Measurement by clinical lab results, vital signs, physical exam, and electrocardiogram (ECG)

Maximum concentration of ABT-414
Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks

Measurement of the maximum concentration of ABT- 414 in the blood

Minimum Concentration of ABT-414
Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks

Measurement of the minimum concentration of ABT-414 in the blood

Half-life of ABT-414
Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks

Measurement of the clearance of ABT-414

Phase 1 - Safety (Number of subjects with adverse events and/or dose limiting toxicities)
Every 1-3 weeks for an average of 20 weeks

Evaluation of vital signs, clinical lab testing, adverse event monitoring, physical exam and electrocardiogram (ECG) (periodic) under different dosing schedules, drug infusion times, and manufacturing processes.

Phase 1 - Pharmacokinetic profile
Multiple timepoints Week 1 and Week 7

Cmax, Cmin, and half-life

Phase 2 - Efficacy
Every 6-9 weeks for an average of 20 weeks

Objective response per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST)

Secondary Endpoints

Objective Response Rate
At each visit for approximately 1 year
Overall Survival
At each visit for approximately 1 year
Duration of Overall Response
At each visit for approximately 1 year
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A of Phase 1 portionEXPERIMENTALABT-414 administered every other weeks monotherapy
Phase 2 portionEXPERIMENTALABT-414 administered every other weeks in combination with temozolomide
Arm C of Phase 1 portionEXPERIMENTALABT-414 administered every other weeks in combination with radiation and temozolomide
Arm B of Phase 1 portionEXPERIMENTALABT-414 administered every other weeks in combination with radiation and temozolomide
Arm AEXPERIMENTALABT-414 in combination with radiation and temozolomide
Arm BEXPERIMENTALABT-414 in combination with temozolomide
Arm CEXPERIMENTALABT-414 monotherapy
ABT-414EXPERIMENTALSubjects with solid tumors (Phase 1) and squamous non-small cell lung cancer (NSCLC) (Phase 2)

Interventions

NameTypeDescription
Whole Brain RadiationRADIATIONWhole Brain Radiation will be administered in over 30 fractions as per the procedure in each study site.
TemozolomideDRUGTemozolomide will be administered per label.
ABT-414DRUGABT-414 will be administered by intravenous infusion
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Eligibility Criteria

Age Range20 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * Japanese participants with WHO grade III or IV malignant glioma * 70 or above on Karnofsky Performance Status in Arm A of Phase 1 portion and Phase 2 portion * 80 or above on Karnofsky Performance Status in Arm B and Arm C of Phase 1 portion * Adequate bone marrow function * R...

Countries:JapanUnited StatesCanada
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Frequently asked questions about ABT-414

What is ABT-414 used for?

ABT-414 is an investigational small molecule being studied for the treatment of malignant glioma, glioblastoma multiforme, and squamous cell tumors. It is developed by AbbVie Inc. and is currently in Phase 1 clinical development.

Who makes ABT-414?

ABT-414 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is in Phase 1 clinical trials for oncology indications.

What phase is ABT-414 in?

ABT-414 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed for solid tumors, glioblastoma multiforme, and malignant glioma.

What clinical trials is ABT-414 in?

ABT-414 has been studied in three completed Phase 1 trials: NCT01741727 for squamous cell tumors, NCT01800695 for glioblastoma multiforme, and NCT02590263 for malignant glioma and glioblastoma multiforme in Japanese subjects. Total enrollment across these trials was 202 participants.

Is ABT-414 the same as depatuxizumab mafodotin?

ABT-414 is also known as depatuxizumab mafodotin, an antibody-drug conjugate targeting EGFR. It is being developed by AbbVie for the treatment of EGFR-amplified cancers, including glioblastoma multiforme.