Recent Updates
Recently added Catalysts

JAB-3312

Phase 1

Solid Tumor | Small molecule | Oncology |AbbVie Inc.|Last Updated: Apr 11, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment58
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04720976JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid TumorsPHASE1 COMPLETED 58Mar 23, 2021Dec 19, 2023Apr 11, 202515 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of participants with dose limiting toxicities
24 months

Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. 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. (Dose escalation phase)

Objective response rate (ORR)
24 months

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

Duration of response (DOR)
24 months

DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first. (Dose expansion phase)

Duration of response (DCR)
24 months

DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD). (Dose expansion phase)

Progression-free survival (PFS)
24 months

PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first. (Dose expansion phase)

Overall survival (OS)
24 months

OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor. (Dose expansion phase)

Number of participants with adverse events
24 months

All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments (Dose escalation phase)

Secondary Endpoints
Objective response rate (ORR)
24 months
Duration of response (DOR)
24 months
Duration of response (DCR)
24 months
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
JAB-3312+Pembrolizumab dose escalationEXPERIMENTALDose escalation
JAB-3312+ Binimetinib dose escalationEXPERIMENTALDose escalation
JAB-3312+Pembrolizumab dose expansionEXPERIMENTALDose expansion
JAB-3312+Binimetinib dose expansionEXPERIMENTALDose expansion
JAB-3312+Sotorasib dose escalationEXPERIMENTALDose escalation
JAB-3312+ Osimertinib dose escalationEXPERIMENTALDose escalation
JAB-3312+ Sotorasib dose expansionEXPERIMENTALDose expansion
JAB-3312+ Osimertinib dose expansionEXPERIMENTALDose expansion
Interventions
NameTypeDescription
JAB-3312DRUGJAB-3312 will be administered orally, variable dose.
BinimetinibDRUGBinimetinib will be administered orally.
PembrolizumabDRUGPembrolizumab will be administered as an intravenous infusion.
SotorasibDRUGSotorasib will be administered orally.
OsimertinibDRUGOsimertinib will be administered orally.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Must have histologically or cytologically confirmed metastatic or locally advanced solid tumor. Some cohorts must meet specific expression or gene mutation where indicated * Sufficient organ function * Participants must have at least 1 measurable lesion as defined by RECIST v1...

Countries:United States
Unlock Eligibility Criteria