This is a Phase 1, first-in-human, open-label dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and assess the DLT of JAB-3312. It is anticipated that approximately 24 subjects will be enrolled in the dose-escalation phase of the study. JAB-3312 will be administered orally once daily (QD) in 21-day treatment cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
JAB-3312 will be supplied as 0.25 mg and 1.0 mg capsules.
HealthONE Clinic Services Oncology-Hematology
Denver, Colorado, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States
Washington University School of Medicine
Seattle, Washington, United States
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 with JAB-3312.
Time frame: Approximately 2 years
Find Recommended Phase 2 Dose (RP2D) of JAB-3312
Measurements of MTD (i.e. the highest dose of JAB-3312 associated with the occurrence of Dose Limiting Toxicities (DLTs) in \<33% of patients) or the RP2D (i.e. the highest tested dose that is declared safe and tolerable by the Investigators and Sponsor)
Time frame: Approximately 2 years
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
Time frame: Approximately 2 years
Area under the curve
Area under the plasma concentration time curve of JAB-3312
Time frame: Approximately 2 years
Cmax
Highest observed plasma concentration of JAB-3312
Time frame: Approximately 2 years
Tmax
Time of highest observed plasma concentration of JAB-3312
Time frame: Approximately 2 years
T1/2
Half life of JAB-3312
Time frame: Approximately 2 years
Objective response rate ( ORR )
ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
Time frame: Approximately 2 years
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.
Time frame: Approximately 2 years
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