JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors
- Conditions
- Solid TumorNSCLC
- Interventions
- Registration Number
- NCT04720976
- Lead Sponsor
- Allist Pharmaceuticals, Inc.
- Brief Summary
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description JAB-3312+ Sotorasib dose expansion JAB-3312 Dose expansion JAB-3312+ Binimetinib dose escalation Binimetinib Dose escalation JAB-3312+Sotorasib dose escalation JAB-3312 Dose escalation JAB-3312+Pembrolizumab dose expansion JAB-3312 Dose expansion JAB-3312+Binimetinib dose expansion JAB-3312 Dose expansion JAB-3312+ Binimetinib dose escalation JAB-3312 Dose escalation JAB-3312+ Osimertinib dose expansion JAB-3312 Dose expansion JAB-3312+ Osimertinib dose escalation JAB-3312 Dose escalation JAB-3312+Pembrolizumab dose escalation JAB-3312 Dose escalation JAB-3312+Pembrolizumab dose expansion Pembrolizumab Dose expansion JAB-3312+Sotorasib dose escalation Sotorasib Dose escalation JAB-3312+Pembrolizumab dose escalation Pembrolizumab Dose escalation JAB-3312+Binimetinib dose expansion Binimetinib Dose expansion JAB-3312+ Osimertinib dose escalation Osimertinib Dose escalation JAB-3312+ Sotorasib dose expansion Sotorasib Dose expansion JAB-3312+ Osimertinib dose expansion Osimertinib Dose expansion
- Primary Outcome Measures
Name Time Method Number of participants with adverse events 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)
Objective response rate (ORR) 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) 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)
Progression-free survival (PFS) 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) 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 dose limiting toxicities 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)
Duration of response (DCR) 24 months DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD). (Dose expansion phase)
- Secondary Outcome Measures
Name Time Method Duration of response (DOR) 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)
Number of participants with adverse events 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)
Objective response rate (ORR) 24 months ORR is defined as the proportion of participants with complete response or partial response (CR+PR). (Dose escalation phase)
Duration of response (DCR) 24 months DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD). (Dose escalation phase)
Progression-free survival (PFS) 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)
Overall survival (OS) 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)
Area under the plasma concentration-time curve (AUC) 24 months Area under the plasma concentration time curve of JAB-3312(dose escalation phase)
Plasma concentration (Cmax) 24 months Highest observed plasma concentration of JAB-3312(dose escalation phase)
Time to achieve Cmax (Tmax) 24 months Time of highest observed plasma concentration of JAB-3312(dose escalation phase)
Trial Locations
- Locations (1)
Research Site
🇺🇸Salt Lake City, Utah, United States