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A Phase I Study of LP-108 in Patients With Relapsed or Refractory B-cell Lymphoma

NCT04356846 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2023-05-01

No results posted yet for this study

Summary

This study is a multi-center, open-label, single-arm phase I clinical study of LP-108. Patients with relapsed or refractory chronic lymphocytic leukemia (CLL, arm A) and other B cell non-Hodgkin's lymphoma (NHL, Arm B). Each arm has a dose escalation phase (phase Ia) and expansion phase (phase Ib). During the dose escalation phase, the primary objectives are to define dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and to explore a recommended phase II dose. Dose escalation is based on the classic "3 + 3" design, while accelerated titration is applied to the initial lower doses. After the RP2Ds are determined, additional patients will be enrolled in the expansion phase to further evaluation the safety, PK and preliminary efficacy of LP-108, each therapy can enroll 12-20 subjects.

Conditions

Interventions

DRUG

LP-108 tablet

Taken orally within 30 minutes after a meal at the designated dose, once daily.

Sponsors & Collaborators

  • Guangzhou Lupeng Pharmaceutical Company LTD.

    collaborator INDUSTRY

  • Newave Pharmaceutical Inc

    collaborator INDUSTRY

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2023-12-01
Completion
2023-12-01
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04356846 on ClinicalTrials.gov