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RECRUITING Phase 1

Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.

NCT04775745 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG LP-168

Study Locations (4)

Ohio

  • University of Cincinnati — Cincinnati
  • Ohio State University — Columbus

North Carolina

  • Duke Univerisity — Durham

Utah

  • Huntsman Cancer Institute, University of Utah — Salt Lake City

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2021-07-19
Est. Completion 2027-12-31
Phase Phase 1

Sponsor

Newave Pharmaceutical

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04775745

The ClinicalTrials.gov registry entry for NCT04775745 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Newave Pharmaceutical, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 7 conditions, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 1 intervention — of which LP-168 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04775745 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Ohio, North Carolina, Utah. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04775745 about?

NCT04775745 is a clinical study titled "Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.". 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.

What is the current status of trial NCT04775745?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2021-07-19. Estimated completion is 2027-12-31.

What conditions does trial NCT04775745 study?

This clinical trial studies the following conditions: Mantle Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Diffuse Large B Cell Lymphoma, Waldenstrom Macroglobulinemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04775745?

The interventions under investigation include: LP-168 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04775745?

This trial is sponsored by Newave Pharmaceutical, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04775745 being conducted?

This trial has 4 study locations across North Carolina, Ohio, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial