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

April 9, 2025 updated by: Allist Pharmaceuticals, Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Research Site
      • Scottsdale, Arizona, United States, 85259
        • Research Site
    • California
      • Los Angeles, California, United States, 90033
        • Research Site
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Research Site
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Research Site
      • Orange City, Florida, United States, 32763
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Research Site
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States, 63130
        • Research Site
    • New York
      • New York, New York, United States, 10016
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: JAB-3312+Pembrolizumab dose escalation
Dose escalation
Drug: JAB-3312
JAB-3312 will be administered orally, variable dose.
Drug: Pembrolizumab
Pembrolizumab will be administered as an intravenous infusion.
Experimental: JAB-3312+ Binimetinib dose escalation
Dose escalation
Drug: JAB-3312
JAB-3312 will be administered orally, variable dose.
Drug: Binimetinib
Binimetinib will be administered orally.
Experimental: JAB-3312+Pembrolizumab dose expansion
Dose expansion
Drug: JAB-3312
JAB-3312 will be administered orally, variable dose.
Drug: Pembrolizumab
Pembrolizumab will be administered as an intravenous infusion.
Experimental: JAB-3312+Binimetinib dose expansion
Dose expansion
Drug: JAB-3312
JAB-3312 will be administered orally, variable dose.
Drug: Binimetinib
Binimetinib will be administered orally.
Experimental: JAB-3312+Sotorasib dose escalation
Dose escalation
Drug: JAB-3312
JAB-3312 will be administered orally, variable dose.
Drug: Sotorasib
Sotorasib will be administered orally.
Experimental: JAB-3312+ Osimertinib dose escalation
Dose escalation
Drug: JAB-3312
JAB-3312 will be administered orally, variable dose.
Drug: Osimertinib
Osimertinib will be administered orally.
Experimental: JAB-3312+ Sotorasib dose expansion
Dose expansion
Drug: JAB-3312
JAB-3312 will be administered orally, variable dose.
Drug: Sotorasib
Sotorasib will be administered orally.
Experimental: JAB-3312+ Osimertinib dose expansion
Dose expansion
Drug: JAB-3312
JAB-3312 will be administered orally, variable dose.
Drug: Osimertinib
Osimertinib will be administered orally.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with dose limiting toxicities
Time Frame: 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)
24 months
Objective response rate (ORR)
Time Frame: 24 months
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)
Time Frame: 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)
24 months
Duration of response (DCR)
Time Frame: 24 months
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)
Time Frame: 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)
24 months
Overall survival (OS)
Time Frame: 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)
24 months
Number of participants with adverse events
Time Frame: 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)
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 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 escalation phase)
24 months
Overall survival (OS)
Time Frame: 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 escalation phase)
24 months
Objective response rate (ORR)
Time Frame: 24 months
ORR is defined as the proportion of participants with complete response or partial response (CR+PR). (Dose escalation phase)
24 months
Duration of response (DOR)
Time Frame: 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 escalation phase)
24 months
Duration of response (DCR)
Time Frame: 24 months
DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD). (Dose escalation phase)
24 months
Plasma concentration (Cmax)
Time Frame: 24 months
Highest observed plasma concentration of JAB-3312(dose escalation phase)
24 months
Time to achieve Cmax (Tmax)
Time Frame: 24 months
Time of highest observed plasma concentration of JAB-3312(dose escalation phase)
24 months
Area under the plasma concentration-time curve (AUC)
Time Frame: 24 months
Area under the plasma concentration time curve of JAB-3312(dose escalation phase)
24 months
Number of participants with adverse events
Time Frame: 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 expansion phase)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allist Pharmaceuticals, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 23, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 19, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 19, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JAB-3312-1003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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