Asset profile

JAB-3312

Small molecule

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Phase 3underway

Evidence outlook · registrational

Non-Small Cell Lung Cancer: registrational readout pending

Entered Phase 3 on weak signal mid-stage evidence. Registrational readout expected around 2029-09-30.

NCT04720976: The study treated participants in several open-label combination cohorts without randomization or a comparator arm; 58 participants were enrolled across dose-escalation and dose-expansion groups. Although the planned primary outcomes included clinical measures such as objective response, progression-free survival, and overall survival, no results are posted, so it is not possible to determine whether any endpoint was met.

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Competitive landscape

63 competitors in this universe: 3 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication; 58 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
JAB-3312: this drugPhase 3Small moleculeSHP2
GH21Phase 1/2Small moleculeSHP2
BBP-398Phase 1Small moleculeSHP2
HBI-2376Phase 1Small moleculeSHP2
Afatinib (Gilotrif)ApprovedSmall moleculeEGFR/HER1, HER2, HER4
Alectinib (Alecensa)ApprovedSmall moleculeALK
Alymsys (bevacizumab-Maly)ApprovedMonoclonal antibodyVEGF-A
AmivantamabApprovedMultispecific antibodyEGFR x c-MET
AtezolizumabApprovedMonoclonal antibodyPD-L1
BAT1706 (Avzivi)ApprovedMonoclonal antibodyVEGF-A
BAY2927088 (Hyrnuo)ApprovedSmall moleculeHER2 (ERBB2) exon 20 insertions and point mutations; also mutant-selective EGFR
BevacizumabApprovedMonoclonal antibodyVEGF-A, Vascular Endothelial Growth Factor Inhibitor
Bevacizumab-Awwb (MVASI)ApprovedMonoclonal antibodyVEGF-A
BinimetinibApprovedSmall moleculeMEK1/2
BrigatinibApprovedSmall moleculeALK
CapmatinibApprovedSmall moleculeMET

…and 48 more. Research shows the complete landscape.

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Upcoming events

(2 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2027 (1)
March 2027 (1)
Phase 1/2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2027-03 · NCT05288205 · CT.gov ↗
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2029 (1)
September 2029 (1)
Phase 3Non-Small Cell Lung CancerRecruiting
Est. primary completion 2029-09-30 · NCT06416410 · CT.gov ↗
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All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.