Clinical trial · Interventional
JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors
A Phase 1/2a, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3312 Based Combination Therapies in Adult Patients With Advanced Solid Tumors
NCT04720976CI-TRIAL-00088467completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the safety and tolerability of JAB-3312 administered in investigational regimens in adult participants with advanced solid tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Binimetinib | Drug | Binimetinib | ALIAS |
| JAB-3312 | Drug | — | UNRESOLVED |
| Osimertinib | Drug | Osimertinib | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| Sotorasib | Drug | Sotorasib | ALIAS |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- JAB-3312+Pembrolizumab dose escalation
- description
- Dose escalation
- interventionNames
- Drug: JAB-3312
- Drug: Pembrolizumab
- type
- EXPERIMENTAL
- label
- JAB-3312+ Binimetinib dose escalation
- description
- Dose escalation
- interventionNames
- Drug: JAB-3312
- Drug: Binimetinib
- type
- EXPERIMENTAL
- label
- JAB-3312+Pembrolizumab dose expansion
- description
- Dose expansion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 v1.1 * Must be able to provide an archived tumor sample * ECOG performance status score of 0 or 1. Exclusion Criteria: * History of cancer that is histologically distinct from the cancers under study * Active or untreated central nervous system (CNS) metastases * History of pneumonitis or interstitial lung disease (ILD) * Has active hepatitis B, hepatitis C infection, HIV * Any severe and/or uncontrolled medical conditions * LVEF ≤50% * QTcF \>470 msec
References
Publications (1)
- DERIVEDKang D, Wang Y, Lin Y, Ma WW, Morgensztern D, Leventakos K, Bi C, Ding Y, Xiong J, Yan M, Sun X, Wang P, Ma C, Wang Y. JAB-3312, a Potent Allosteric SHP2 Inhibitor That Enhances the Efficacy of RTK/RAS/MAPK and PD-1 Blockade Therapies. Clin Cancer Res. 2025 Jul 15;31(14):3019-3032. doi: 10.1158/1078-0432.CCR-24-3691. PMID 40333694