A Study of LP-168 in Participants With Relapse or Refractory B-Cell Lymphoma
ConditionB-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGuangzhou Lupeng Pharmaceutical Company LTD.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adequate hematologic function.
Adequate hepatic and renal function.
Ability to receive study drug therapy orally and willing to receive examinations.
Willingness of men and women of reproductive potential (defined as following menarche and not postmenopausal [and 2 years of non-therapy-induced amenorrhea] or surgically sterile) to observe conventional and effective birth control.
Disqualifiers
According to the 2017 revised WHO Lymphoma Classification Criteria, patients diagnosed with the following diseases: Burkitt lymphoma or Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, and post-transplant lymphoproliferative disease(PTLD).
Prior malignancy (other than the disease under study) within the past 3 years, except for curatively treated basal or squamous cell skin cancer, carcinoma in situ of the cervix or breast cancer.
Disease states where clinical manifestations may be difficult to control, including HIV, HBV, HCV, syphilis positive or active bacterial and fungal infections; Disease affects the central nervous system with obvious symptoms; Autoimmune hemolytic anemia or Idiopathic thrombocytopenic purpura. Any gastrointestinal conditions that may severely affect the study drug absorption or pharmacokinetic parameters.
Subjects who cannot tolerate urine collection, venipuncture, lymph node biopsy, and bone marrow aspiration.
Trial design
Design model
Parallel
Treatments tested in this trial
LP-168 tablet
DrugSubjects to take LP-168 orally with 240mL water, without food, Once daily or twice daily
Treatment groups
200 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Phase I Dose EscalationExperimental treatment 1 intervention
Group B: Phase I Dose Expansion AExperimental treatment 1 intervention
Group C: Phase I Dose Expansion BExperimental treatment 1 intervention
Group D: Phase I Dose Expansion CExperimental treatment 1 intervention
Group E: Phase I Dose Expansion DExperimental treatment 1 intervention
Group F: Phase I Dose Expansion EExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum Tolerated Dose (MTD)
Phase 1a
Time frame
Up to 24 Months2
Recommended dose for Phase2 (RP2D)
Phase Ia/Ib
Time frame
Up to 24 Months3
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 MonthsSecondary outcomes
1
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 Months2
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 Months3
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 Months4
Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) Of LP-168
Phase Ia/Ib
Time frame
Up to 48 hours post doseSponsors and contacts
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Source ClinicalTrials.gov