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ABBV-399

Phase 1

Advanced Solid Tumors Cancer | Small molecule | Oncology |AbbVie Inc.|Last Updated: Mar 14, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Clinical trial landscape

ABBV-399 · 1 trial · 1 indication

Phase 1 1
NCT03311477A Study to Evaluate the Safety and Pharmacokinetics ABBV-399 in Japanese Participants With Solid TumorsAdvanced Solid Tumors Cancer
COMPLETED9 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety and Pharmacokinetics ABBV-399 in Japanese Participants With Solid Tumors
Advanced Solid Tumors CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

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

AUC (0-t) is defined as area under the concentration versus time curve from time zero (pre-dose) to the time of the last measurable concentration.

Maximum Tolerated Dose (MTD) or maximally administered dose (MAD) for ABBV-399
Up to 21 days

MTD/MAD is defined as the highest dose level at which less than 2 of 6 (or \< 33% if cohort is expanded beyond 6) participants experience a dose limiting toxicity.

Terminal elimination half life (t1/2)
Up to 24 months
Maximum Observed Concentration (Cmax)
Up to 24 months

Maximum observed concentration (Cmax)

Time to Cmax (Tmax)
Up to 24 months

Secondary Endpoints

Progression-Free Survival (PFS) Time
Up to 24 months
Objective Response Rate (ORR)
Up to 24 months
Duration of response (DOR)
Up to 24 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ABBV-399EXPERIMENTALABBV-399 via intravenous administration at escalating dose levels.

Interventions

NameTypeDescription
ABBV-399DRUGIntravenous infusion
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Participant with histologically confirmed advanced solid tumor. * Participant must have advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit. * Participant has an Eastern Cooperative Oncol...

Countries:Japan
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Frequently asked questions about ABBV-399

What is ABBV-399 used for?

ABBV-399 is an investigational small molecule being studied for the treatment of advanced solid tumors cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its safety and pharmacokinetics in patients with advanced solid tumors.

Who makes ABBV-399?

ABBV-399 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in patients with advanced solid tumors.

What phase is ABBV-399 in?

ABBV-399 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development for advanced solid tumors cancer.

What clinical trials is ABBV-399 in?

ABBV-399 has one completed Phase 1 clinical trial, identified as NCT03311477. This study evaluated the safety and pharmacokinetics of ABBV-399 in Japanese participants with solid tumors. The trial enrolled 9 participants and was conducted in Japan.

Is ABBV-399 FDA approved?

ABBV-399 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for advanced solid tumors cancer. The drug has completed a Phase 1 trial, but it remains under investigation and has not received regulatory approval.