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JAB-3068

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04721223JAB-3068 Activity in Adult Patients With Advanced Solid TumorsPHASE1 COMPLETED 12Apr 26, 2021Dec 29, 2023Sep 19, 20243 China
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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 — 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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