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Small Molecule Inhibitor

LP-168 for Lymphoma

Phase 1
Recruiting
Research Sponsored by Newave Pharmaceutical Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at cycle 1: day 1, day 2, day 8, day 9, day 15, day 22, day 28; at cycle 3: day 28; at cycle 6 day 28; (each cycle is 28 days
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and works well.

Who is the study for?
This trial is for adults with certain B-cell malignancies who've had at least two prior treatments. They should have good kidney, liver, and bone marrow function and not be on strong immune system suppressants or certain other drugs. People with recent cancer therapies, significant heart ECG abnormalities, or a history of Richter's transformation can't join.Check my eligibility
What is being tested?
The study tests LP-168, an oral drug for relapsed/refractory B-cell malignancies. It's a phase I trial to see how safe it is and how the body handles it (pharmacokinetics) at different doses.See study design
What are the potential side effects?
Potential side effects of LP-168 aren't detailed here but may include typical reactions to cancer medications such as nausea, fatigue, blood count changes, and possible organ-specific inflammation based on its pharmacological class.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lymphoma is a low-grade B-cell type, such as follicular or marginal zone.
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My blood clotting, kidney, and liver functions are within normal ranges.
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I have a specific type of blood cancer and have had at least 2 treatments if it's WM, FL, MCL, DLBCL, or HCL.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at cycle 1: day 1, day 2, day 8, day 9, day 15, day 22, day 28; at cycle 3: day 28; at cycle 6 day 28; (each cycle is 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and at cycle 1: day 1, day 2, day 8, day 9, day 15, day 22, day 28; at cycle 3: day 28; at cycle 6 day 28; (each cycle is 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD)
Pyruvate Kinase
Recommended Phase 2 dose (RP2D)
Secondary outcome measures
Duration of Response (DOR)
Objective Response Rate (ORR)
Progression-Free Survival (PFS)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose Expansion PhaseExperimental Treatment1 Intervention
Additional subjects will be recruited to further explore the safety, tolerability, PK, and efficacy in specific subject subgroups.
Group II: Dose Escalation PhaseExperimental Treatment1 Intervention
Three to six subjects per treatment cohort will be assigned to receive sequentially higher oral doses of LP-168 on a once or twice daily schedule for 28 days, starting at a dose of 100 mg/day.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Waldenstrom Macroglobulinemia (WM) is commonly treated with therapies that target specific pathways involved in the growth and survival of malignant B-cells. Small molecule inhibitors, such as Bruton’s tyrosine kinase (BTK) inhibitors (e.g., ibrutinib), block signals that promote B-cell proliferation and survival. This is crucial for WM patients as it directly interferes with the disease's progression. Other treatments include proteasome inhibitors (e.g., bortezomib), which disrupt protein degradation in cancer cells, leading to cell death, and monoclonal antibodies (e.g., rituximab), which target specific proteins on the surface of B-cells, marking them for destruction by the immune system. These mechanisms are vital as they offer targeted approaches to manage and potentially reduce the burden of WM.

Find a Location

Who is running the clinical trial?

Newave Pharmaceutical IncLead Sponsor
3 Previous Clinical Trials
210 Total Patients Enrolled
~16 spots leftby Jul 2025