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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
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To evaluate the safety and tolerability of JAB-3312 administered in investigational regimens in adult participants with advanced solid tumors.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JAB-3312+Pembrolizumab dose escalation | Experimental | Dose escalation |
|
| JAB-3312+ Binimetinib dose escalation | Experimental | Dose escalation |
|
| JAB-3312+Pembrolizumab dose expansion | Experimental | Dose expansion |
|
| JAB-3312+Binimetinib dose expansion | Experimental | Dose expansion |
|
| JAB-3312+Sotorasib dose escalation | Experimental | Dose escalation |
|
| JAB-3312+ Osimertinib dose escalation | Experimental | Dose escalation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JAB-3312 | Drug | JAB-3312 will be administered orally, variable dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Phoenix | Arizona | 85054 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40333694 | Derived | 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. |
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|
| JAB-3312+ Sotorasib dose expansion | Experimental | Dose expansion |
|
| JAB-3312+ Osimertinib dose expansion | Experimental | Dose expansion |
|
| Binimetinib | Drug | Binimetinib will be administered orally. |
|
| Pembrolizumab | Drug | Pembrolizumab will be administered as an intravenous infusion. |
|
| Sotorasib | Drug | Sotorasib will be administered orally. |
|
| Osimertinib | Drug | Osimertinib will be administered orally. |
|
| 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 |
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) | DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD). (Dose escalation 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 escalation 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 escalation phase) | 24 months |
| Plasma concentration (Cmax) | Highest observed plasma concentration of JAB-3312(dose escalation phase) | 24 months |
| Time to achieve Cmax (Tmax) | Time of highest observed plasma concentration of JAB-3312(dose escalation phase) | 24 months |
| Area under the plasma concentration-time curve (AUC) | Area under the plasma concentration time curve of JAB-3312(dose escalation 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 expansion phase) | 24 months |
| 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 |
| ID | Term |
|---|---|
| C581313 | binimetinib |
| C582435 | pembrolizumab |
| C000706028 | sotorasib |
| C000596361 | osimertinib |
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