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JAB-3068

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |AbbVie Inc.|Trials Updated: Sep 19, 2024

JAB-3068 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2001

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

JAB-3068 clinical trials

JAB-3068 · 1 trial · 4 indications

Phase 1 1
NCT04721223JAB-3068 Activity in Adult Patients With Advanced Solid TumorsAdvanced Solid Tumor
COMPLETED12 Analytics
PHASE1COMPLETED
JAB-3068 Activity in Adult Patients With Advanced Solid Tumors
Advanced Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with dose limiting toxicities
24 months

Incidence of dose limiting toxicities (DLTs) . A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle with JAB-3068 and JS001.

Objective response rate (ORR)
24 months

ORR is defined as the proportion of participants with complete response or partial response (CR+PR).

Secondary Endpoints

Plasma concentration (Cmax)
24 months
Time to achieve Cmax (Tmax)
24 months
Area under the plasma concentration-time curve (AUC)
24 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
JAB-3068+PD1 inhibitor Part1EXPERIMENTALJAB-3068+JS001 dose escalation
JAB-3068+PD1 inhibitor Part2EXPERIMENTALJAB-3068+JS001 dose expansion

Interventions

NameTypeDescription
JAB-3068DRUGJAB-3068 administrated orally as a tablet.
PD1 inhibitorDRUGJS001 administrated as an intravenous(IV) infusion.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Written informed consent, according to local guidelines, signed and dated by the participant prior to the performance of any study-specific procedures, sampling, or analyses. * Participant must be ≥18 years of age at the time of signature of the informed consent form (ICF). * ...

Countries:China
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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Advanced Solid Tumor")

Frequently asked questions about JAB-3068

What is JAB-3068?

JAB-3068 is an investigational small molecule drug being developed by AbbVie Inc. (ticker ABBV) for the treatment of advanced solid tumors. It is in Phase 1 clinical development and has been studied in a completed Phase 1 trial in China.

What is JAB-3068 used for?

JAB-3068 is being studied for advanced solid tumors, including esophageal squamous cell carcinoma, non-small cell lung cancer, and head and neck squamous cell carcinoma. It is investigational and has not been approved for any indication.

Who is developing JAB-3068?

JAB-3068 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program for this investigational oncology drug.

What phase is JAB-3068 in?

JAB-3068 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA or any other regulatory agency.

What clinical trials is JAB-3068 in?

JAB-3068 has been evaluated in one completed Phase 1 trial, NCT04721223, titled "JAB-3068 Activity in Adult Patients With Advanced Solid Tumors." The trial enrolled 12 adults aged 18 years and older in China and included patients with advanced solid tumors, esophageal squamous cell carcinoma, non-small cell lung cancer, and head and neck squamous cell carcinoma.