Solid TumorPhase 1/2NCT04720976
JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors
A Phase 1/2 study testing JAB-3312, Binimetinib and Pembrolizumab in people with Solid Tumor and NSCLC, run by Allist Pharmaceuticals, Inc. at 15 sites in United States.
Trial summary
To evaluate the safety and tolerability of JAB-3312 administered in investigational regimens in adult participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, NSCLC
- What is being tested?
- JAB-3312, Binimetinib and Pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 15 sitesUnited States
- Study dates
- 23 Mar 2021to 19 Dec 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Research Site
Chicago, Illinois, 60637
Research Site
Detroit, Michigan, 48202
Research Site
Houston, Texas, 77030
Research Site
Indianapolis, Indiana, 46202
Research Site
Jacksonville, Florida, 32224
Research Site
Los Angeles, California, 90033
Research Site
New Haven, Connecticut, 06510
Research Site
New York, New York, 10016
Research Site
Oklahoma City, Oklahoma, 73104
Research Site
Orange City, Florida, 32763
Research Site
Phoenix, Arizona, 85054
Research Site
Rochester, Minnesota, 55902
Research Site
Salt Lake City, Utah, 84112
Research Site
Scottsdale, Arizona, 85259
Research Site
St Louis, Missouri, 63130
About this study
Official title: 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.
Read the 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.
- Conditions
- Solid Tumor, NSCLC
- Being tested
- JAB-3312, Binimetinib, Pembrolizumab, Sotorasib, Osimertinib
- Keywords
- KRAS G12C, EGFR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JAB-3312Drug
JAB-3312 will be administered orally, variable dose.
BinimetinibDrug
Binimetinib will be administered orally.
PembrolizumabDrug
Pembrolizumab will be administered as an intravenous infusion.
SotorasibDrug
Sotorasib will be administered orally.
OsimertinibDrug
Osimertinib will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| JAB-3312+Pembrolizumab dose escalation | Experimental | Dose escalation Receives: Drug: JAB-3312; Drug: Pembrolizumab |
| JAB-3312+ Binimetinib dose escalation | Experimental | Dose escalation Receives: Drug: JAB-3312; Drug: Binimetinib |
| JAB-3312+Pembrolizumab dose expansion | Experimental | Dose expansion Receives: Drug: JAB-3312; Drug: Pembrolizumab |
| JAB-3312+Binimetinib dose expansion | Experimental | Dose expansion Receives: Drug: JAB-3312; Drug: Binimetinib |
| JAB-3312+Sotorasib dose escalation | Experimental | Dose escalation Receives: Drug: JAB-3312; Drug: Sotorasib |
| JAB-3312+ Osimertinib dose escalation | Experimental | Dose escalation Receives: Drug: JAB-3312; Drug: Osimertinib |
| JAB-3312+ Sotorasib dose expansion | Experimental | Dose expansion Receives: Drug: JAB-3312; Drug: Sotorasib |
| JAB-3312+ Osimertinib dose expansion | Experimental | Dose expansion Receives: Drug: JAB-3312; Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 24 months
Secondary outcomes (9)
Objective response rate (ORR)
ORR is defined as the proportion of participants with complete response or partial response (CR+PR). (Dose escalation phase)
Measured: 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 escalation phase)
Measured: 24 months
Duration of response (DCR)
DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD). (Dose escalation phase)
Measured: 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 escalation phase)
Measured: 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 escalation phase)
Measured: 24 months
Plasma concentration (Cmax)
Highest observed plasma concentration of JAB-3312(dose escalation phase)
Measured: 24 months
Time to achieve Cmax (Tmax)
Time of highest observed plasma concentration of JAB-3312(dose escalation phase)
Measured: 24 months
Area under the plasma concentration-time curve (AUC)
Area under the plasma concentration time curve of JAB-3312(dose escalation phase)
Measured: 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 expansion phase)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start23 Mar 2021
- Primary completion19 Dec 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Allist Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allist Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720976
- Sponsor's protocol ID
- JAB-3312-1003
- Status last verified
- Mar 2025
- First submitted
- 18 Jan 2021
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 40333694
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04720976
- Acronym / sponsor ID
- JAB-3312-1003
- Conditions
- Solid Tumor, NSCLC
- Keywords
- KRAS G12C, EGFR
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Allist Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and tolerability of JAB-3312 administered in investigational regimens in adult participants with advanced solid tumors.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| JAB-3312+Pembrolizumab dose escalation | Experimental | Drug: JAB-3312, Drug: PembrolizumabDose escalation |
| JAB-3312+ Binimetinib dose escalation | Experimental | Drug: JAB-3312, Drug: BinimetinibDose escalation |
| JAB-3312+Pembrolizumab dose expansion | Experimental | Drug: JAB-3312, Drug: PembrolizumabDose expansion |
| JAB-3312+Binimetinib dose expansion | Experimental | Drug: JAB-3312, Drug: BinimetinibDose expansion |
| JAB-3312+Sotorasib dose escalation | Experimental | Drug: JAB-3312, Drug: SotorasibDose escalation |
| JAB-3312+ Osimertinib dose escalation | Experimental | Drug: JAB-3312, Drug: OsimertinibDose escalation |
| JAB-3312+ Sotorasib dose expansion | Experimental | Drug: JAB-3312, Drug: SotorasibDose expansion |
| JAB-3312+ Osimertinib dose expansion | Experimental | Drug: JAB-3312, Drug: OsimertinibDose expansion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JAB-3312JAB-3312 will be administered orally, variable dose. | Drug | JAB-3312+ Binimetinib dose escalation, JAB-3312+ Osimertinib dose escalation, JAB-3312+ Osimertinib dose expansion, JAB-3312+ Sotorasib dose expansion, JAB-3312+Binimetinib dose expansion, JAB-3312+Pembrolizumab dose escalation, JAB-3312+Pembrolizumab dose expansion, JAB-3312+Sotorasib dose escalation |
| BinimetinibBinimetinib will be administered orally. | Drug | JAB-3312+ Binimetinib dose escalation, JAB-3312+Binimetinib dose expansion |
| PembrolizumabPembrolizumab will be administered as an intravenous infusion. | Drug | JAB-3312+Pembrolizumab dose escalation, JAB-3312+Pembrolizumab dose expansion |
| SotorasibSotorasib will be administered orally. | Drug | JAB-3312+ Sotorasib dose expansion, JAB-3312+Sotorasib dose escalation |
| OsimertinibOsimertinib will be administered orally. | Drug | JAB-3312+ Osimertinib dose escalation, JAB-3312+ Osimertinib dose expansion |
Primary outcome
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)
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)
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)
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)
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)
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)
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)
9 secondary outcomes
Objective response rate (ORR)
Time frame: 24 months
Duration of response (DOR)
Time frame: 24 months
Duration of response (DCR)
Time frame: 24 months
Progression-free survival (PFS)
Time frame: 24 months
Overall survival (OS)
Time frame: 24 months
Plasma concentration (Cmax)
Time frame: 24 months
Time to achieve Cmax (Tmax)
Time frame: 24 months
Area under the plasma concentration-time curve (AUC)
Time frame: 24 months
Number of participants with adverse events
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Derived from this study: PubMed 40333694Kang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JAB-3312, Binimetinib and Pembrolizumab in people with Solid Tumor and NSCLC, run by Allist Pharmaceuticals, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dose limiting toxicities (time frame: 24 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04720976, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.