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JAB-3312

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment58

FDA Designations

No designations recorded

Clinical trial landscape

JAB-3312 · 1 trial · 2 indications

Phase 1 1
NCT04720976JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid TumorsSolid Tumor
COMPLETED58 Analytics
PHASE1COMPLETED
JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors
Solid TumorUnlock trial analytics

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
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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.
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Eligibility Criteria

Age Range18 Years to 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
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumor")

Frequently asked questions about JAB-3312

What is JAB-3312 used for?

JAB-3312 is an investigational small molecule being developed for the treatment of solid tumors, including non-small cell lung cancer (NSCLC). It is currently in Phase 1 clinical development and has not been approved by the FDA.

Who makes JAB-3312?

JAB-3312 is being developed by AbbVie Inc. (NYSE: ABBV). The drug is currently in Phase 1 clinical development for the treatment of solid tumors.

What phase is JAB-3312 in?

JAB-3312 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed.

What clinical trials is JAB-3312 in?

JAB-3312 has been studied in one clinical trial, NCT04720976, titled "JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors." This Phase 1 trial enrolled 58 participants with solid tumors or NSCLC and has been completed.

Is JAB-3312 FDA approved?

JAB-3312 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of solid tumors, including NSCLC.