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ABBV-075

Phase 1

Cancer | Small molecule | Oncology |AbbVie Inc.|Last Updated: Nov 29, 2019

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment128

FDA Designations

No designations recorded

Clinical trial landscape

ABBV-075 · 1 trial · 8 indications

Phase 1 1
NCT02391480A Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With CancerCancer
COMPLETED128 Analytics
PHASE1COMPLETED
A Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Cancer
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Tolerated Dose of ABBV-075
Minimum first cycle of dosing (28 days) up to one year for dose escalation segment.

Maximum tolerated dose is defined as the highest dose level at which less than 2 of 6 participants experience the same dose limiting toxicity. If more than 2 participants experience a different dose limiting toxicity, the maximum tolerated dose may be further evaluated or determined to be exceeded based on discussions with the investigators and medical monitors.

Time to Cmax (peak time, Tmax) for ABBV-075
Approximately 24 hours following a single dose of ABBV-075 up to approximately 2 years.
Number of participants with adverse events
Screening, Cycle 1 Day 1, 8 and 15, then Day 1 of each cycle up to approximately 2 years.
Maximum observed plasma concentration (Cmax) of ABBV-075
Approximately 24 hours following a single dose of ABBV-075 up to approximately 2 years.
Area under the curve (AUC)
Cycle 1 Day 1 Pre-dose, 1, 2, 3, 4, 6, 8 and 24 hours post ABBV-075 dosing, and on Cycle 1 Day 15 at 14, 17, 20 hours post dose.

Area under the plasma concentration versus time curve from time 0 (pre-dose) to the time of the last measurable concentration (AUC 0-t).

Secondary Endpoints

Duration of overall response (DOR)
At screening, every 8 weeks from Cycle 1 Day 1, and at the Final visit up to approximately 2 years.
Objective Response Rate (ORR)
At screening, every 8 weeks from Cycle 1 Day 1, and at the Final visit up to approximately 2 years.
Progression Free Survival (PFS)
Screening, every 8 weeks from Cycle 1 Day 1, and at the Final visit up to approximately 2 years.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ABBV-075EXPERIMENTALDose escalation cohorts of ABBV-075 monotherapy
ABBV-075 and venetoclax combinationEXPERIMENTALExpansion cohorts of ABBV-075 and venetoclax combination therapy
ABBV-075 expansionEXPERIMENTALExpansion cohorts of ABBV-075 monotherapy

Interventions

NameTypeDescription
ABBV-075DRUGABBV-075 Oral tablets
VenetoclaxDRUGVenetoclax tablets, film-coated
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: 1. Participant in the dose escalation cohorts must have histological confirmation of locally advanced or metastatic solid tumor that is either refractory after standard of care therapy for the disease or for which standard of care therapy or does not exist. 2. Participants in th...

Countries:United States
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Frequently asked questions about ABBV-075

What is ABBV-075 used for?

ABBV-075 is an investigational small molecule being developed for the treatment of cancer. It has been studied in patients with various cancer types, including breast cancer, non-small cell lung cancer, acute myeloid leukemia, multiple myeloma, prostate cancer, small cell lung cancer, and non-Hodgkin lymphoma.

Who makes ABBV-075?

ABBV-075 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is an investigational small molecule in the oncology therapeutic area.

What phase is ABBV-075 in?

ABBV-075 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to evaluate its safety and pharmacokinetics in patients with cancer.

What clinical trials is ABBV-075 in?

ABBV-075 has been studied in one clinical trial, identified as NCT02391480, titled "A Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Cancer." This Phase 1 trial was completed in the United States and enrolled 128 participants aged 18 years and older.

Is ABBV-075 FDA approved?

ABBV-075 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial. The trial was designed to evaluate safety and pharmacokinetics, and the drug remains in clinical development for the treatment of cancer.