This is an open-label, multi-center Phase 1/2 study of oral LP-168 in patients with CLL/SLL and NHL who have failed or are intolerant to standard of care.
This study includes 2 parts: phase 1a (LP-168 monotherapy dose escalation) and phase 1b (LP-168 dose expansion). In phase 1a, patients will be enrolled using an 3+3 design. The starting dose of LP-168 in oral tablet form is 100 mg/day (e.g., 100 mg once daily \[QD\]). Once the MTD and/or RP2D is identified in phase 1a dose escalation, enrollment will continue to phase 1b dose expansion. Cycle length will be 28 days.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Subjects to take LP-168 orally with 240mL water, without food, Once daily or twice daily
Peking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGMaximum Tolerated Dose (MTD)
Phase 1a
Time frame: Up to 24 Months
Recommended dose for Phase2 (RP2D)
Phase Ia/Ib
Time frame: Up to 24 Months
To evaluate the safety of LP-168 by assessing incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0
Phase Ia/Ib
Time frame: Up to 24 Months
Overall Response Rate
To assess the preliminary anti-tumor activity of LP-168 based on overall response rate (ORR) as assessed by investigator and IRC.
Time frame: Up to 24 Months
Progression Free Survival
To assess the preliminary anti-tumor activity of LP-168 based on Progression free survival (PFS) as assessed by the Investigator and IRC
Time frame: Up to 24 Months
Duration of Response
To assess the preliminary anti-tumor activity of LP-168 based on Duration of response (DOR) as assessed by the Investigator and IRC.
Time frame: Up to 24 Months
Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) Of LP-168
Phase Ia/Ib
Time frame: Up to 48 hours post dose
PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t) Of LP-168
Yuqin Song, MD, PhD
CONTACT
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Phase Ia/Ib
Time frame: Up to 48 hours post dose
PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) Of LP-168
Phase Ia/Ib
Time frame: Up to 48 hours post dose
PK As Assessed By Terminal Half-life (t1/2) Of LP-168
Phase Ia/Ib
Time frame: Up to 48 hours post dose