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ABSK112

Phase 1

Non-Small Cell Lung Cancer | Small molecule | Oncology |cbdMD, Inc.|Last Updated: Mar 18, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment164

FDA Designations

No designations recorded

Clinical trial landscape

ABSK112 · 1 trial · 1 indication

Phase 1 1
NCT06225804A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK112 in Patients With Non-Small Cell Lung CancerNon-Small Cell Lung Cancer
RECRUITING164 Analytics
PHASE1RECRUITING
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK112 in Patients With Non-Small Cell Lung Cancer
Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of DLT
from Day1 to Day28

Dose-limiting toxicities

AEs
The date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 50 months.

Adverse events

AESIs
The date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 50 months.

Adverse events of special interest (AESIs)

SAEs
The date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 50 months.

Serious adverse events (SAEs)

Secondary Endpoints

Cmax
From date of enrollment(Day1) until the date of end of treatment visit, assessed up to 50 months
AUC
From date of enrollment(Day1) until the date of end of treatment visit, assessed up to 50 months
t1/2
From date of enrollment(Day1) until the date of end of treatment visit, assessed up to 50 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ABSK112EXPERIMENTALDuring the escalation part, the administration of oral ABSK112 will be guided by Bayesian optimal interval (BOIN) design based on safety data collected until a maximum tolerated dose (MTD) has been identified. The first dose level will be administered as QD, and different dosing frequencies (e.g., BID) may be explored in subsequent doses depending on emerging safety and pharmacokinetic data. A separate food effect cohort may be conducted. In expansion part, patients will be treated at the selected RDE dose level.

Interventions

NameTypeDescription
ABSK112DRUGIn the escalation part, patients will receive a single dose of oral ABSK112 on Cycle1 Day1 only, and then patients will continuously receive ABSK112 once daily (QD) or twice daily (BID) in subsequent cycles. In the expansion part, patients will each be treated at the selected RDE dose level.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: 1. Patients should understand, sign, and date the written informed consent form prior to screening. 2. Male or female aged 18 years or older. 3. Patients with histologically or cytologically confirmed locally advanced (and not a candidate for definitive therapy) or metastatic NS...

Countries:United StatesChina
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials

Frequently asked questions about ABSK112

What is ABSK112 used for?

ABSK112 is an investigational small molecule being developed for the treatment of Non-Small Cell Lung Cancer (NSCLC). It is currently in Phase 1 clinical development, meaning it is still being studied for safety, tolerability, and pharmacokinetics in patients with this condition.

Who makes ABSK112?

ABSK112 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting a Phase 1 clinical trial of ABSK112 in patients with Non-Small Cell Lung Cancer.

What phase is ABSK112 in?

ABSK112 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing Phase 1 trial is recruiting patients to evaluate the safety, tolerability, and pharmacokinetics of ABSK112 in Non-Small Cell Lung Cancer.

What clinical trials is ABSK112 in?

ABSK112 is being studied in one active clinical trial, identified as NCT06225804. This Phase 1 study is assessing the safety, tolerability, and pharmacokinetics of ABSK112 in patients with Non-Small Cell Lung Cancer. The trial is recruiting participants in the United States and China, with a target enrollment of 164 patients.

Is ABSK112 the same as any other drug?

ABSK112 is a distinct investigational drug candidate. No alternative names for ABSK112 have been reported. It is being developed as a small molecule for Non-Small Cell Lung Cancer and is currently in Phase 1 clinical trials.