RecruitingCLL/SLLWaldenstrom MacroglobulinemiaFollicular Lymphoma
Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.
Eligible age
18+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
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About this study
This is a phase I, multi-center, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and clinical activity of LP-168 in subjects with relapsed or refractory B-cell malignancies. LP-168 is a small molecule inhibitor.
Sponsor: Newave Pharmaceutical Inc
You may qualify if…
- ✓ A subject will be eligible for study participation if he/she meets the following criteria:
- ✓ Subjects are eligible with B-cell malignancies, WM, FL, MCL, MZL, DLBCL, HCL, CLL, SLL, based upon 2016 updated WHO classification. Those subjects with WM, FL, MCL, DLBCL, or HCL must have received at least 2 prior systemic therapies.
- ✓ Low-grade B-cell lymphomas as follicular Grade 1, 2, or 3A, marginal zone or small lymphocytic lymphoma.
- ✓ Subject must have adequate coagulation, renal, and hepatic function, per local laboratory reference ranges at Screening as follows:
- ✓ Activated partial thromboplastin time (APTT) and prothrombin time (PT) not to exceed 1.5 × ULN
- ✓ Calculated creatinine clearance (CrCl) ≥ 60 mL/min using 24-hour CrCl OR Cockcroft-Gault formula.
- ✓ Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 ×ULN; Bilirubin ≤ 1.5 × ULN (except subjects with Gilbert's Syndrome, who may have a bilirubin \> 1.5 × ULN, per discussion between the Investigator and the Medical Monitor).
- ✓ Subjects must have adequate bone marrow independent of growth factor support per local laboratory reference range at screening as follows:
You may not qualify if…
- ✕ A subject will not be eligible for study participation if he/she meets any of the following criteria.
- ✕ Subject has received any of the following therapies within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug, or has not recovered to ≤ Grade 1 clinically significant adverse effect(s)/toxicity(s) of the previous therapy (other than alopecia):
- ✕ Any anti-cancer therapy including chemotherapy, biologic or immunotherapy, radiotherapy, etc;
- ✕ Any investigational therapy, including targeted small molecule agents.
- ✕ For CLL subjects who come off BCR antagonists (BTK inhibitors, PI3K inhibitors, etc.) treatment, allow washout for 2 days as these subjects progress quickly after treatment discontinuation and then remain eligible (steroids may be given during these two days to allow disease control).
- ✕ Subjects who require immediate cytoreduction. However, subjects may receive up to two days of steroids for symptoms of impending organ impairment and remain eligible.
- ✕ Subject has received the following medications or therapies within 7 days prior to the first dose of study drug:
- ✕ Steroid therapy (at dosages equivalent to prednisone \>20 mg/day) for anti-neoplastic intent (except as noted in exclusion criteria #3);
Where it's recruiting
Source: ClinicalTrials.gov · NCT04775745 · last updated 2026-02-13