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JAB-3068

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

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 9 trials (matched to "Advanced Solid Tumor")

Frequently asked questions about JAB-3068

What is JAB-3068 used for?

JAB-3068 is an investigational small molecule being developed for the treatment of advanced solid tumors, including esophageal squamous cell carcinoma, non-small cell lung cancer, and head and neck squamous cell carcinoma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who is developing JAB-3068?

JAB-3068 is being developed by AbbVie Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol ABBV. The drug is in Phase 1 clinical development for advanced solid tumors.

What phase is JAB-3068 in?

JAB-3068 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. A Phase 1 trial has been completed, but the drug remains in early-stage clinical testing.

What clinical trials is JAB-3068 in?

JAB-3068 has one completed Phase 1 clinical trial, identified as NCT04721223, titled "JAB-3068 Activity in Adult Patients With Advanced Solid Tumors." The trial enrolled 12 participants 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.

Is JAB-3068 the same as any other drug?

JAB-3068 is the primary name for this investigational drug. No alternative names have been reported for this compound in the available clinical trial information.