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JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors

NCT ID: NCT04720976

Last Updated: 2025-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-23

Study Completion Date

2023-12-19

Brief Summary

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To evaluate the safety and tolerability of JAB-3312 administered in investigational regimens in adult participants with advanced solid tumors.

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Detailed Description

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To assess the safety and tolerability and determine the Recommended phase 2 dose (RP2D) of JAB-3312 in combination with PD1 inhibitor or MEK inhibitor in patients with advanced solid tumors.

Conditions

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Solid Tumor NSCLC

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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JAB-3312+Pembrolizumab dose escalation

Dose escalation

Group Type EXPERIMENTAL

JAB-3312

Intervention Type DRUG

JAB-3312 will be administered orally, variable dose.

Pembrolizumab

Intervention Type DRUG

Pembrolizumab will be administered as an intravenous infusion.

JAB-3312+ Binimetinib dose escalation

Dose escalation

Group Type EXPERIMENTAL

JAB-3312

Intervention Type DRUG

JAB-3312 will be administered orally, variable dose.

Binimetinib

Intervention Type DRUG

Binimetinib will be administered orally.

JAB-3312+Pembrolizumab dose expansion

Dose expansion

Group Type EXPERIMENTAL

JAB-3312

Intervention Type DRUG

JAB-3312 will be administered orally, variable dose.

Pembrolizumab

Intervention Type DRUG

Pembrolizumab will be administered as an intravenous infusion.

JAB-3312+Binimetinib dose expansion

Dose expansion

Group Type EXPERIMENTAL

JAB-3312

Intervention Type DRUG

JAB-3312 will be administered orally, variable dose.

Binimetinib

Intervention Type DRUG

Binimetinib will be administered orally.

JAB-3312+Sotorasib dose escalation

Dose escalation

Group Type EXPERIMENTAL

JAB-3312

Intervention Type DRUG

JAB-3312 will be administered orally, variable dose.

Sotorasib

Intervention Type DRUG

Sotorasib will be administered orally.

JAB-3312+ Osimertinib dose escalation

Dose escalation

Group Type EXPERIMENTAL

JAB-3312

Intervention Type DRUG

JAB-3312 will be administered orally, variable dose.

Osimertinib

Intervention Type DRUG

Osimertinib will be administered orally.

JAB-3312+ Sotorasib dose expansion

Dose expansion

Group Type EXPERIMENTAL

JAB-3312

Intervention Type DRUG

JAB-3312 will be administered orally, variable dose.

Sotorasib

Intervention Type DRUG

Sotorasib will be administered orally.

JAB-3312+ Osimertinib dose expansion

Dose expansion

Group Type EXPERIMENTAL

JAB-3312

Intervention Type DRUG

JAB-3312 will be administered orally, variable dose.

Osimertinib

Intervention Type DRUG

Osimertinib will be administered orally.

Interventions

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JAB-3312

JAB-3312 will be administered orally, variable dose.

Intervention Type DRUG

Binimetinib

Binimetinib will be administered orally.

Intervention Type DRUG

Pembrolizumab

Pembrolizumab will be administered as an intravenous infusion.

Intervention Type DRUG

Sotorasib

Sotorasib will be administered orally.

Intervention Type DRUG

Osimertinib

Osimertinib will be administered orally.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role collaborator

Allist Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Phoenix, Arizona, United States

Site Status

Research Site

Scottsdale, Arizona, United States

Site Status

Research Site

Los Angeles, California, United States

Site Status

Research Site

New Haven, Connecticut, United States

Site Status

Research Site

Jacksonville, Florida, United States

Site Status

Research Site

Orange City, Florida, United States

Site Status

Research Site

Chicago, Illinois, United States

Site Status

Research Site

Indianapolis, Indiana, United States

Site Status

Research Site

Detroit, Michigan, United States

Site Status

Research Site

Rochester, Minnesota, United States

Site Status

Research Site

St Louis, Missouri, United States

Site Status

Research Site

New York, New York, United States

Site Status

Research Site

Oklahoma City, Oklahoma, United States

Site Status

Research Site

Houston, Texas, United States

Site Status

Research Site

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40333694 (View on PubMed)

Other Identifiers

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JAB-3312-1003

Identifier Type: -

Identifier Source: org_study_id

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