a study of lp-168 in participants with relapse or refractory b-cell lymphoma

Conditions: B-cell Lymphoma

Summary: 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.

Eligibility criteria:
key inclusion criteria: * per 2017 revised who lymphoma classification criteria, subject must have either: diagnosed with relapsed or refractory dlbcl or fl and require treatment in the opinion of the investigator and have received 2 lines soc. diagnosed with relapsed or refractory non-hodgkin's lymphoma associated with b-cell proliferation (such as cll\\ sll \\ mcl \\ mzl \\ wm, etc.) in need of treatment in the opinion of the investigator and have received 1 line soc. * 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. key exclusion criteria: * 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. * subjects who have received the following treatments within 4 weeks or 5 half-lives before the first dose of lp-168: antitumor therapies including myelosuppressive chemotherapy, targeted therapy, biological therapy and/or immunotherapy; any investigational treatment; patients who have undergone major surgery, severe trauma or radiotherapy. * subjects who have received the following treatments within 2 weeks before the first dose of lp-168: steroids or traditional herbal medicine for antitumor purposes; strong and moderate cyp3a inhibitors and inducers; all drugs that may cause qtc interval prolongation or torsional tachycardia. * 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.