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AB-106, digoxin

Phase 1

Solid Tumor | Small molecule | Oncology |Nuvation Bio Inc.|Last Updated: Nov 21, 2024

Target and mechanism

ModalitySmall molecule

Also known as AB-106

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials2
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

AB-106, digoxin · 2 trials · 1 indication

Phase 1 2
NCT05357820A Study of AB-106 in Chinese Healthy Adult Men Evaluated the Effects of Itraconazole and Rifampicin on AB-106 PKSolid Tumor
COMPLETED56 Analytics
NCT05357911A Study on the Effect of AB-106 on the Pharmacokinetics of DigoxinSolid Tumor
COMPLETED16 Analytics
PHASE1COMPLETED
A Study of AB-106 in Chinese Healthy Adult Men Evaluated the Effects of Itraconazole and Rifampicin on AB-106 PK
Solid TumorUnlock trial analytics
PHASE1COMPLETED
A Study on the Effect of AB-106 on the Pharmacokinetics of Digoxin
Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

AB-106 PK Exposure Parameters
29 days

Peak Plasma Concentration (Cmax)

The PK exposure parameters of digoxin
17 days

Area under the plasma concentration versus time curve (AUC)

Secondary Endpoints

AB-106 PK Parameters
29 days
Safety Assessment
47 days
The PK parameters of digoxin
17 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Itraconazole cohortEXPERIMENTAL -
Rifampicin cohortEXPERIMENTAL -
digoxin cohortEXPERIMENTAL -

Interventions

NameTypeDescription
AB-106, ItraconazoleDRUGsingle dose AB-106 at Day1, Itraconazole QD at Day14\~Day28, single dose AB-106 at Day17
AB-106, RifampicinDRUGsingle dose AB-106 at Day1, Itraconazole QD at Day14\~Day32, single dose AB-106 at Day21
AB-106, digoxinDRUGPeriod 1, single dose of 0.25mg digoxin; Period 2, Coadministrate AB-106 600mg and 0.25mg digoxin
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. The subject is willing to give written informed consent. 2. The subject is capable to communicate well with investigator and comply with comply with protocol throughout the study. 3. Aged between 18 to 55 at giving written informed consent. 4. Chinese male healthy subjects (N...

Countries:China
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumor")

Frequently asked questions about AB-106, digoxin

What is AB-106 used for?

AB-106 is an investigational small molecule being developed for oncology indications, specifically non-small cell lung cancer (NSCLC) and solid tumors. It is currently in Phase 2 clinical development for advanced NSCLC harboring ROS1 fusion gene, and has also been studied in healthy volunteers for pharmacokinetic effects.

Who makes AB-106?

AB-106 is being developed by Nuvation Bio Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol NUVB. The company is conducting clinical trials for this investigational oncology drug.

What phase is AB-106 in?

AB-106 is in Phase 2 clinical development. The most advanced trial is a Phase 2 study in patients with advanced non-small cell lung cancer harboring ROS1 fusion gene, which is active but not recruiting. Earlier Phase 1 studies have been completed.

What clinical trials is AB-106 in?

AB-106 has been studied in three clinical trials. The main trial is NCT04395677, a Phase 2 study in 173 patients with advanced NSCLC harboring ROS1 fusion gene in China. Two Phase 1 studies, NCT05357820 and NCT05357911, evaluated drug interactions in healthy volunteers and have been completed.

Is AB-106 FDA approved?

AB-106 is not FDA approved. It is an investigational drug currently in clinical development. The most advanced trial is a Phase 2 study in non-small cell lung cancer, which is active but not recruiting. No approval status has been reported.

What does AB-106 target?

AB-106 targets the ROS1 fusion gene in non-small cell lung cancer. The Phase 2 clinical trial specifically enrolls patients with advanced NSCLC harboring ROS1 fusion gene, indicating that the drug is designed to act on this molecular target.