No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Newave Pharmaceutical Inc · Industry
Who this trial is looking for
This trial is looking for patients with specific types of B-cell cancers who have not responded to previous treatments. Participants will take a new oral medication called LP-168 to see how safe and effective it is.
Are You a Good Fit for This Trial?
Must not be takingStrong CYP3A4 inhibitorsStrong CYP2C8 inducers/inhibitorsSteroid therapy above 20 mg/dayProton pump inhibitors
Rules you outRichter's transformationSevere liver dysfunctionSevere kidney dysfunctionSerum amylase or lipase above normal limits
You may be able to join if
I have a B-cell malignancy such as Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia.
I have had at least 2 previous treatments for my cancer.
I have adequate kidney and liver function.
I have enough healthy blood cells according to screening tests.
I may have low-grade B-cell lymphomas.
You may not be able to join if
I have had any anti-cancer therapy within 14 days before starting this trial.
I need immediate treatment to lower my cancer burden.
I have serious heart issues as shown in my ECG results.
I have had a recent hematopoietic stem cell transplant within 90 days.
I have current significant complications from a prior transplant.
I require anticoagulation with Warfarin.
I have had another active cancer in the past 3 years, except certain skin cancers.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Status
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 h…
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.
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