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
1 other identifier
interventional
58
1 country
15
Brief Summary
To evaluate the safety and tolerability of JAB-3312 administered in investigational regimens in adult participants with advanced solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2021
Typical duration for phase_1
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2021
CompletedFirst Posted
Study publicly available on registry
January 22, 2021
CompletedStudy Start
First participant enrolled
March 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2023
CompletedApril 11, 2025
March 1, 2025
2.7 years
January 18, 2021
April 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Number of participants with dose limiting toxicities
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)
24 months
Objective response rate (ORR)
ORR is defined as the proportion of participants with complete response or partial response (CR+PR). (Dose expansion phase)
24 months
Duration of response (DOR)
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)
24 months
Duration of response (DCR)
DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD). (Dose expansion phase)
24 months
Progression-free survival (PFS)
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)
24 months
Overall survival (OS)
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)
24 months
Number of participants with adverse events
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)
24 months
Secondary Outcomes (9)
Objective response rate (ORR)
24 months
Duration of response (DOR)
24 months
Duration of response (DCR)
24 months
Progression-free survival (PFS)
24 months
Overall survival (OS)
24 months
- +4 more secondary outcomes
Study Arms (8)
JAB-3312+Pembrolizumab dose escalation
EXPERIMENTALDose escalation
JAB-3312+ Binimetinib dose escalation
EXPERIMENTALDose escalation
JAB-3312+Pembrolizumab dose expansion
EXPERIMENTALDose expansion
JAB-3312+Binimetinib dose expansion
EXPERIMENTALDose expansion
JAB-3312+Sotorasib dose escalation
EXPERIMENTALDose escalation
JAB-3312+ Osimertinib dose escalation
EXPERIMENTALDose escalation
JAB-3312+ Sotorasib dose expansion
EXPERIMENTALDose expansion
JAB-3312+ Osimertinib dose expansion
EXPERIMENTALDose expansion
Interventions
JAB-3312 will be administered orally, variable dose.
Binimetinib will be administered orally.
Pembrolizumab will be administered as an intravenous infusion.
Sotorasib will be administered orally.
Osimertinib will be administered orally.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allist Pharmaceuticals, Inc.lead
- AbbViecollaborator
Study Sites (15)
Research Site
Phoenix, Arizona, 85054, United States
Research Site
Scottsdale, Arizona, 85259, United States
Research Site
Los Angeles, California, 90033, United States
Research Site
New Haven, Connecticut, 06510, United States
Research Site
Jacksonville, Florida, 32224, United States
Research Site
Orange City, Florida, 32763, United States
Research Site
Chicago, Illinois, 60637, United States
Research Site
Indianapolis, Indiana, 46202, United States
Research Site
Detroit, Michigan, 48202, United States
Research Site
Rochester, Minnesota, 55902, United States
Research Site
St Louis, Missouri, 63130, United States
Research Site
New York, New York, 10016, United States
Research Site
Oklahoma City, Oklahoma, 73104, United States
Research Site
Houston, Texas, 77030, United States
Research Site
Salt Lake City, Utah, 84112, United States
Related Publications (1)
Kang 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: 40333694DERIVED
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2021
First Posted
January 22, 2021
Study Start
March 23, 2021
Primary Completion
December 19, 2023
Study Completion
December 19, 2023
Last Updated
April 11, 2025
Record last verified: 2025-03