This is a Phase 1, first-in-human, open-label study of JAB-8263 to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) and assess the DLT. 30 subjects with advanced solid tumor will be enrolled.
JAB-8263 is a small-molecule inhibitor of the highly conserved bromodomain pockets of the bromodomain and extraterminal (BET) proteins. The objectives of this study are: To determine the maximum-tolerated dose (MTD) and assess the dose-limiting toxicity (DLT) of JAB-8263 as a single agent to adult subjects with advanced solid tumors To assess the safety and tolerability of JAB-8263 To characterize the pharmacokinetic (PK) parameters and pharmacodynamics (PDc) To evaluate preliminary antitumor activity of JAB-8263
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Variable dose, orally Q2D with 28 days each cycle
SCRI HeatlthONE
Denver, Colorado, United States
Florida Cancer Center, Lake Mary
Lake City, Florida, United States
Tennessee Oncology Nashville
Nashville, Tennessee, 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-8263
Time frame: Approximately 2.5 years
Find Recommended Phase 2 Dose (RP2D) of JAB-8263
Measurements of MTD (i.e. the highest dose of JAB-8263 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 2.5 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 2.5 years
Area under the curve
Area under the plasma concentration time curve of JAB-8263
Time frame: Approximately 2.5 years
Cmax
Highest observed plasma concentration of JAB-8263
Time frame: Approximately 2.5 years
Tmax
Time of highest observed plasma concentration of JAB-8263
Time frame: Approximately 2.5 years
T1/2
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Half life of JAB-8263
Time frame: Approximately 2.5 years
Objective response rate ( ORR )
ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
Time frame: Approximately 2.5 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 2.5 years