Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.
A Phase I, Multicenter, Open-Label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-168 in Subjects With Relapsed or Refractory B-cell Malignancies.
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This early-stage study tests LP-168, a drug taken by mouth, for B-cell cancers that came back or did not respond to treatment. It tests different doses to learn about safety, side effects, how the body handles the drug, and how well it works.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have one of these B-cell cancers: Waldenström macroglobulinemia (WM), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), diffuse large B-cell lymphoma (DLBCL), hairy cell leukemia (HCL), chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL).
- If you have WM, FL, MCL, DLBCL, or HCL, you must have had at least 2 treatments that reach cancer throughout the body.
- Eligible slow-growing lymphomas include follicular lymphoma grades 1, 2, or 3A, marginal zone lymphoma, and small lymphocytic lymphoma.
- Blood clotting, kidney, and liver tests must meet study limits. A liver test exception may be allowed for Gilbert's syndrome, a condition that raises bilirubin.
- Have enough neutrophils, white blood cells that fight infection: at least 1,000 per microliter. Drugs to raise this count are usually not allowed, but an exception may apply if cancer fills much of the bone marrow.
- Have enough platelets, blood cells that help stop bleeding: at least 50,000 per microliter, or at least 20,000 if CLL clearly causes the low count.
- Have hemoglobin, the protein that carries oxygen in blood, of at least 8 g/dL. Blood transfusions may be used to reach this level.
Who can't join
- Had cancer treatment or an experimental treatment too recently, or still have more than mild major side effects other than hair loss. The usual waiting period is 14 days or the time for 5 drug half-lives, whichever is shorter. A half-life is the time for half a drug to leave the body. Some CLL drugs need only a 2-day wait.
- Need treatment right away to lower the number of cancer cells. Up to 2 days of steroids may be allowed if organs are at risk.
- Used certain medicines within 7 days before LP-168, including high-dose steroids for cancer or medicines that strongly affect how the body breaks down drugs. Also excluded if you need warfarin, a blood thinner.
- Need acid-reducing medicines that do not fit study rules. Proton pump inhibitors must stop at least 7 days before LP-168 and stay stopped. H2 blockers may be taken only 2–3 hours after LP-168. Local antacids must be taken at least 2 hours before or after it.
- Have certain abnormal heart rhythm tests, or amylase or lipase blood levels above 1.5 times the normal upper limit. These enzymes help digest food.
- Have ever had Richter's transformation, when CLL changes into a faster-growing lymphoma, for the phase 1a part of the study. Other active cancers within the past 3 years may also exclude you, with exceptions for certain treated skin or cervical cancers and cancers treated with the aim of curing them.
- Had a stem cell transplant within 90 days before LP-168, or need medicines that weaken the immune system after a transplant. After relapse following a donor transplant, these medicines must usually have stopped at least 4 weeks earlier.
- Have significant graft-versus-host disease, when donated cells attack your body. Some steroid creams or steroid doses up to the equivalent of 20 mg of prednisone daily are allowed.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 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: * Absolute Neutrophil Count (ANC) ≥1000/uL; * An exception is for subjects with an ANC\<1000/uL and bone marrow heavily infiltrated with underlying disease (approximately 60% or more) may use growth factor to achieve the ANC eligibility criteria per discussion between the Investigator and the Medical Monitor. * Platelet count ≥ 50,000/µL - OR - Platelet count ≥ 20,000/ µL if thrombocytopenia is clearly due to CLL disease under study (per Investigator discretion) * Hemoglobin ≥8.0g/dL, and can be achieved by transfusion Exclusion Criteria: 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); * Cytochrome P450, family 3, subfamily A (CYP3A4) strong inhibitors and strong CYP2C8 inducers/inhibitors. * Potent CYP3A4 inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort. * Subjects require treatment with systemic acid-reducing agents including H-2-receptor antagonists and proton pump inhibitors with the following exceptions: * Proton pump inhibitors should be discontinued at least 7 days prior and held throughout the study * If concurrent use of an H2 blocking agent is necessary, it must be administered only between 2 and 3 hours after the dose of LP-168. If not taken during this time, the dose of H2 blocking agents should not be taken again until 2-3 hours after the next dose of LP-168. * If concurrent use of a local antacid is necessary, it must be administered 2 or more hours before and/or 2 or more hours after the dose of LP-168. * Subject has significant screening electrocardiogram (ECG) abnormalities including. 2nd degree AV block type II 3rd degree block, Grade 2 or higher bradycardia, and corrected QT interval (QTc) ≥ 480ms. * Serum amylase \> 1.5 × ULN or serum lipase \> 1.5 × ULN. * Subject has any history of Richter's transformation for Phase 1a portion of the trial. * Subjects who have undergone autologous/allogeneic hematopoietic stem cell transplantation (HSCT) therapy within 90 days of the first dose of LP-168, or patients on immunosuppressive therapy post-HSCT at the time of Screening, or currently with clinically significant graft-versus-host disease (GVHD) as per treating physician (Patients in relapse after allogeneic transplantation must be off treatment with systemic immunosuppressive agents for at least 4 weeks. The use of topical steroids and/or up to 20 mg/day prednisone or equivalent systemic steroids for ongoing GVHD is permitted. * Subject has a history of other active malignancies other than B-cell malignancies within the past 3 years prior to study entry, with the exception of: * Adequately treated in situ carcinoma of the cervix uteri; * Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; * Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent. * Subject requires anticoagulation with Warfarin.
Study sites (4)
NC
- Duke Univerisity · Durham, NC 27708More trials in Durham
OH
- University of Cincinnati · Cincinnati, OH 45221More trials in Cincinnati
- Ohio State University · Columbus, OH 43210More trials in Columbus
UT
- Huntsman Cancer Institute, University of Utah · Salt Lake City, UT 84112More trials in Salt Lake City