Recent Updates
Recently added Catalysts

ABBV-085

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |AbbVie Inc.|Last Updated: Apr 5, 2019

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment85

FDA Designations

No designations recorded

Clinical trial landscape

ABBV-085 · 1 trial · 4 indications

Phase 1 1
NCT02565758ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid TumorsAdvanced Solid Tumors
COMPLETED85 Analytics
PHASE1COMPLETED
ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Terminal elimination half life of ABBV-085.
UP to 24 months
Maximum observed plasma concentration (Cmax) of ABBV-085.
Up to 24 months
Number of participants with Adverse Events
Up to 24 months

Collect all adverse events at each visit.

Area under the curve (AUC) from time zero to the last measurable concentration AUC(0-t) of ABBV-085.
Up 24 months

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

Secondary Endpoints

Objective response rate (ORR)
Up to 24 months
Progression free survival (PFS)
Up to 24 months
Duration of overall response (DOR)
Up to 24 months
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A4 (ABBV-085)EXPERIMENTALABBV-085 administered on at 28 day cycle and enrolling at MD Anderson
Arm A3 (ABBV-085)EXPERIMENTALABBV-085 will be administered at every cycle (28-day cycles).

Interventions

NameTypeDescription
ABBV-085DRUGAdministered as an intravenous infusion in 28-day dosing cycles.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: 1. Participants with advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2. 3. Participants must have measurable disease per Response Evaluation Criteria In...

Countries:United StatesFranceSpain
Unlock Eligibility Criteria

Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about ABBV-085

What is ABBV-085 used for?

ABBV-085 is an investigational small molecule being studied for the treatment of advanced solid tumors, including undifferentiated pleomorphic sarcoma, squamous cell carcinoma of the head and neck, and carcinoma of the breast. It is in Phase 1 clinical development and has not been approved by the FDA.

Who makes ABBV-085?

ABBV-085 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is currently in Phase 1 clinical development for advanced solid tumors.

What phase is ABBV-085 in?

ABBV-085 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 1 trial has been completed, and the drug remains under investigation for advanced solid tumors.

What clinical trials is ABBV-085 in?

ABBV-085 has been studied in one clinical trial, NCT02565758, titled 'ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors.' This Phase 1 trial enrolled 85 participants and was completed. The trial was conducted in the United States, France, and Spain.

Is ABBV-085 an antibody drug conjugate?

The clinical trial for ABBV-085 describes it as an antibody drug conjugate, though the drug is also classified as a small molecule. It is being investigated for advanced solid tumors, including undifferentiated pleomorphic sarcoma, squamous cell carcinoma of the head and neck, and breast carcinoma.